Left Head Rotation as an Alternative to Difficult Tracheal Intubation: Randomized Open Label Clinical Trial

Background Tracheal intubation is a life-saving intervention, and optimizing the patient’s head and neck position for the best glottic view is a crucial step that accelerates the procedure. The left head rotation maneuver has been recently described as an innovative alternative to the traditional sniffing position used for tracheal intubation with marked improvement in glottic visualization. Objective This study compared the glottic view and intubating conditions in the sniffing position versus left head rotation during direct laryngoscopy. Methods This randomized, open-label clinical trial enrolled 52 adult patients admitted to Baguio General Hospital and Medical Center from September 2020 to January 2021 for an elective surgical procedure requiring tracheal intubation under general anesthesia. Intubation was done using a 45° left head rotation in the experimental group (n=26), while the control group (n=26) was intubated using the conventional sniffing position. Glottic visualization and intubation difficulty with the two procedures were assessed using the Cormack-Lehane grade and Intubation Difficulty Scale, respectively. Successful intubation is measured by observing a capnographic waveform in the end-tidal CO2 monitor after placement of the endotracheal tube. Results There was no statistically significant difference in the Cormack-Lehane grade, with 85% (n=44) of patients classified under grades 1 (n=11 and n=15) and 2 (n=11 and n=7) in the left head rotation and sniffing position groups, respectively. In addition, there were no statistically significant differences in the Intubation Difficulty Scale scores of patients intubated with left head rotation or sniffing position; 30.7% (n=8) of patients in both groups were easily intubated, while 53.8% (n=14) in left head rotation and 57.6% (n=15) in sniffing position groups were intubated with slight difficulty. Similarly, there were no significant differences between the 2 techniques in any of the 7 parameters of the Intubation Difficulty Scale, although numerically fewer patients required the application of additional lifting force (n=7, 26.9% vs n=11, 42.3%) or laryngeal pressure (n=3, 11.5% vs n=7, 26.9%) when intubated with left head rotation. The intubation success rate with left head rotation was 92.3% versus 100% in the sniffing position, but this difference was not statistically significant. Conclusions Left head rotation produces comparable laryngeal exposure and intubation ease to the conventional sniffing position. Therefore, left head rotation may be an alternative for patients who cannot be intubated in the sniffing position, especially in hospitals where advanced techniques such as video laryngoscopes and flexible bronchoscopes are unavailable, as is the case in this study. However, since our sample size was small, studies with a larger study population are warranted to establish the generalizability of our findings. In addition, we observed inadequate familiarity among anesthesiologists with the left head rotation technique, and the intubation success rate may improve as practitioners attain greater technical familiarization. Trial Registration International Standard Randomised Controlled Trial Number (ISRCTN)ISRCTN23442026; https://www.isrctn.com/ISRCTN23442026

yes: all primary outcomes were signi cantly better in intervention group vs control partly: SOME primary outcomes were signi cantly better in intervention group vs control no statistically signi cant difference between control and intervention potentially harmful: control was signi cantly better than intervention in one or more outcomes inconclusive: more research is needed Other: Approx. Percentage of Users (starters) still using the app as recommended after Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if o ine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
C l e a r s e l e c t i o n Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential 1a-ii) Non-web-based components or important co-interventions in title Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
C l e a r s e l e c t i o n Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The left head rotation maneuver has been recently described as an innovative approach to tracheal intubation with marked improvement in glottic visualization and can be an alternative before proceeding to a surgical airway. subitem not at all important 1 2 3 4 5 essential 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) C l e a r s e l e c t i o n Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Intubation was done using a 45-degree left head rotation in the experimental group (n=26), while the control group (n=26) was intubated using the conventional sniffing position. Glottic visualization and intubation difficulty with left head rotation and sniffing position were assessed using Cormack-Lehane Grade and Intubation Difficulty Scale, respectively. Successful intubation is measured by observing a capnographic waveform in the end-tidal CO2 monitor after placement of the endotracheal tube. Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Left head rotation produces comparable laryngeal exposure and intubation ease to the conventional sniffing position.

Randomization
Enrolled participants who met the inclusion criteria were randomized by draw lots into the experimental (intubated with left head rotation; n=26) and control groups (intubated in the sniffing position; n=26). Group assignments were written on a sheet of paper, which were either 'Group A' (left head rotation) or 'Group B' (sniffing position). The papers were shuffled for randomization and numbered for equal participant allocation to each group. The consultant or senior anesthesiology resident opened the papers drawn prior to the induction of anesthesia to determine group assignment. Thus, the consultant or senior anesthesiology resident served as the observer, and the researcher (D.C.) was blinded during data collection to avoid bias. In addition, senior anesthesiologists who participated in the data collection were in Year 2 or Year 3 of their clinical residency. The flow of patient selection and randomization is described in Figure 1. 4b) Settings and locations where the data were collected Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

Ethical Considerations
The protocol and informed consent forms were reviewed and approved by the institutional ethics board of Baguio General Hospital & Medical Center (Protocol Number: BGHMC-ERC-2020-27). The researcher obtained written informed consent the day before the scheduled operation. The consent form was available in English, Filipino, and Ilocano, with identical content covering the nature of the study; study procedure; risks, benefits, and complications; data security and confidentiality; and voluntary participation and withdrawal.
The contents of the consent forms were also verbally explained to the participants, and they were reminded that they were free to withdraw from the study at any point, and if they decided to withdraw prior to the surgical procedure, treatment quality would not vary, and standard care will be provided. The researcher also provided an audio-visual presentation of the intubation procedures in a manner or language that the patient, senior resident, and consultant understood.
Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Several steps were taken to ensure the confidentiality and security of the data. Only D.C. has access to the password-protected data, and upon completion of the study, all data were archived in the Hospital Information and Management System (HIMS) office for future reference. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study institutional affiliations are displayed

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
C l e a r s e l e c t i o n Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable ; September 2020 to January 2021 ; intervention did not undergo major changes during the evaluation process Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The consultant or senior anesthesiology resident served as the observer, and the researcher (D.C.) was blinded during data collection to avoid bias.
subitem not at all important 1 2 3 4 5 essential 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting.
C l e a r s e l e c t i o n Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study flowcharts and algorithms were uploaded

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
C l e a r s e l e c t i o n Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not a web-based application

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci c group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
C l e a r s e l e c t i o n Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not a web-based application Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The flow of patient selection and randomization procedure as well as the conceptual framework is described in the study

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
C l e a r s e l e c t i o n Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The anesthesiology resident or consultant in charge performed a physical examination and a thorough airway evaluation during the preoperative evaluation to assess the ease of intubation. Copy and paste relevant sections from manuscript text residents and consultants were asked for a feedback after the protocol was done thru interview Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study no changes to the trial outcomes after the trial commenced Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study It was stated in the sample size: "Due to limited studies with intubation using left head rotation, the sample size computation was based on the study by Khan et al [28], where the authors reported a 68% success rate in intubation with direct laryngoscopy using the left lateral position. Therefore, a sample size of 52, with 26 participants in each group, was computed using OPEN-EPI (version 3.1) with a 95% CI and 80% power, assuming a success rate of 68% with left head rotation and 100% with conventional intubation in the sniffing position.
7b) When applicable, explanation of any interim analyses and stopping guidelines 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study algorithm of the study was done under figure 1 Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Stated under the Randomization: "Enrolled participants who met the inclusion criteria were randomized by draw lots into the experimental (intubated with left head rotation; n=26) and control groups (intubated in the sniffing position; n=26). Group assignments were written on a sheet of paper, which were either "group A" (left head rotation) or "group B" (sniffing position). The papers were shuffled for randomization and numbered for equal participant allocation to each group. The consultant or senior anesthesiology resident opened the papers drawn prior to the induction of anesthesia to determine group assignment. Thus, the consultant or senior anesthesiology resident served as the observer, and the researcher (DPC) was blinded during data collection to avoid bias. " 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Stated under the Randomization: "Enrolled participants who met the inclusion criteria were randomized by draw lots into the experimental (intubated with left head rotation; n=26) and control groups (intubated in the sniffing position; n=26). " Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Draw lots was done for randomization 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Stated under the Randomization: "Enrolled participants who met the inclusion criteria were randomized by draw lots into the experimental (intubated with left head rotation; n=26) and control groups (intubated in the sniffing position; n=26). Group assignments were written on a sheet of paper, which were either "group A" (left head rotation) or "group B" (sniffing position). The papers were shuffled for randomization and numbered for equal participant allocation to each group. The consultant or senior anesthesiology resident opened the papers drawn prior to the induction of anesthesia to determine group assignment. Thus, the consultant or senior anesthesiology resident served as the observer, and the researcher (DPC) was blinded during data collection to avoid bias. The flow of patient selection and randomization is described in Figure 1." subitem not at all important 1 2 3 4 5 essential 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering cointerventions (if any).
C l e a r s e l e c t i o n Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Stated under the Randomization: "The consultant or senior anesthesiology resident served as the observer, and the researcher (DPC) was blinded during data collection to avoid bias. " 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".
C l e a r s e l e c t i o n Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The consultant or senior anesthesiology resident served as the observer, and the researcher (DPC) was blinded during data collection to avoid bias.
12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Thus, whether head rotation improves airway patency and glottic visualization in anesthetized individuals remains uncertain.
Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Baseline characteristics, which included patient sex, age, and BMI, were presented as frequency and percentage, and the differences between experimental and control groups were compared using the chi-square test. Noncontinuous variables, including the Cormack-Lehane grade (grade 1-4) and intubation difficulty (minimum, slight, and moderate to major) distribution of patients were presented as frequency and percentage, and the difference between the 2 study groups was assessed using the chi-square test. Additionally, the central tendency in the Cormack-Lehane grade of patients in the left head rotation and sniffing positions was presented as mean (SD) and median (IQR), and the difference between the 2 study groups was assessed using Student t test. Individual components (N1-N7) of the Intubation Difficulty Scale were presented as frequency and percentage (assessed using Fisher exact test) as well as mean (SD) and median (IQR) (assessed using Student t test). Finally, the intubation success rate was presented as frequency and percentage, and the difference between the 2 study groups was assessed using Fisher exact test. All tests were 2-sided, and P values of <.05 were considered statistically significant.
subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4] Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study informed consent was included in the manuscript Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study risks and complications were explained and there is an immediate management for such under the "safety considerations" 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study September 2020 to January 2021 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" C l e a r s e l e c t i o n Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study no secular events fell into the study period 14b) Why the trial ended or was stopped (early)

15) A table showing baseline demographic and clinical characteristics for each
group NPT: When applicable, a description of care providers (case volume, quali cation, expertise, etc.) and centers (volume) in each group Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study not applicable since this maneuver can be applied even after the study Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study baseline characteristics shown in subitem not at all important 1 2 3 4 5 essential 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide de nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study results shown in table 3 primary and secondary outcomes were defined Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Glottic Visualization and Intubation Difficulty Glottic visualization in nearly 85% (n=44) of the patients in the left head rotation and sniffing position was classified under grades 1 and 2 on the Cormack-Lehane grade scale. There was no significant association between Cormack-Lehane grade and the 2 intubation positions (P=.45; Table 3). Further, 30.7% (n=16) of patients in both positions were intubated with minimum difficulty, 53.8% (n=14) in left head rotation and 57.6% (n=15) in sniffing position were intubated with slight difficulty, and moderate to major difficulty with intubation was noted in only a small number of patients in the 2 groups (n=4, 15.3% in left head rotation and n=3, 11.5% in sniffing position; Table 3). However, intubation difficulty was not significantly different between the 2 positions (P=.91; Table 3).
Although the proportion of patients with an Intubation Difficulty Scale score of 0-1 was numerically higher in the left head rotation group (n=18, 69.2% vs n=13, 50%), the difference was statistically insignificant (P=.26; Table 3). Similarly, the differences in median or median scores of the 7 variables of the Intubation Difficulty Scale were statistically insignificant between the 2 intubation positions (  (Table 3).

Intubation Success Rate
The intubation success rate was 100% in the sniffing position (Table 3). Two patients in the sniffing position classified under moderate to major difficulty on the Intubation Difficulty Scale were intubated successfully after the second attempt; hence, shifting position was deemed unnecessary. On the other hand, 92.3% (n=24) of the patients were successfully intubated using left head rotation (P=.49 vs intubation rate in the sniffing position; Table 3). Three patients in the left head rotation were staged under moderate to major difficulty on the Intubation Difficulty Scale. Patient 1 had an Intubation Difficulty Scale score of 6 and had successful intubation after changing the operator on the second attempt.
Patient 2 had a grade 3 glottic visualization and an Intubation Difficulty Scale score of 7 in the left head rotation position. Despite using a stylet, cricoid pressure, and additional lifting force, intubation was unsuccessful in this patient after 2 attempts. However, Cormack-Lehane grade improved to grade 2 and the Intubation Difficulty Scale score to 3 upon changing to the sniffing position. Patient 3 had grade 4 glottic visualization with an Intubation Difficulty Scale score of 8. The patient's airway could not be secured using left head rotation despite 2 intubation attempts, the use of a stylet, the application of cricoid pressure and additional lifting force, or the change of operator. After changing to the sniffing position, the Cormack-Lehane grade improved from grade 4 to grade 1, the Intubation Difficulty Scale score improved from 8 to 2, and intubation was successful on the first attempt. In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de nitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is de ned (e.g., timeout after idle time) [1] (report under item 6a).
C l e a r s e l e c t i o n Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study intensity of usage is not at all important in the study 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study not applicable in the study Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study analysis in the intubation difficulty scale was also done

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).
C l e a r s e l e c t i o n Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study after the trial, participants were asked for feedback with regards to the use of the method (left head rotation), and the challenges faced with the maneuver Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study after the trial, participants were asked for feedback with regards to the use of the method (left head rotation), and the challenges faced with the maneuver 22) Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group subitem not at all important 1 2 3 4 5 essential 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use). Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study It was stated: "since our sample size was small, studies with a larger study population are warranted to establish the generalizability of our findings. "

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.
C l e a r s e l e c t i o n Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study addressed in the discussion part under limitations of the study Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study It was stated: "since our sample size was small, studies with a larger study population are warranted to establish the generalizability of our findings. " Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other cointerventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
C l e a r s e l e c t i o n Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study the RCT was done in a routine (Elective ) setting Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study full trial protocol can be accessed in IJMR Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study it was stated there was no funding from this study About the CONSORT EHEALTH checklist X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests ( nancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
C l e a r s e l e c t i o n Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study no conflicts of interest were noted in the study As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist?
none but some parts of my study were emphasized with this checklist How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * took me more than a week to finish the questionnaire As a result of using this checklist, do you think your manuscript has improved? * STOP -Save this form as PDF before you click submit To generate a record that you lled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
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