Evaluation of Two Positions for Free Floating Tracheal Intubation in Weightlessness

Study Overview
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Brief Summary
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In a non-randomized, controlled, cross-over simulation study, the investigators evaluated and compared intubation performance of trained operators, using either a conventional laryngoscope in an ice-pick position or a video laryngoscope in a free-floating classic position, in weightlessness and in normogravity. Data were analyzed with the generalized linear mixed-effects models. Primary endpoint was the success rate of tracheal intubation. Time to intubation and the confidence score into the success of tube placement were also recorded as secondary endpoints.

Official Title
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Evaluation and Comparison of Two Positions for Free Floating Tracheal Intubation in Weightlessness: An Ice-Pick Position With a Direct Laryngoscopy and the Classic Approach With VideolaryngoscopyY

Conditions
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Intubation; Difficult or Failed, Intubation Complication

Intervention / Treatment
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* Device: Videolaryngoscopy / Direct Laryngoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers aged between 18 and 65 years old. Absence of pregnancy Belonging to a Health Insurance Coverage by the French Social Security Program or equivalent, proved by a European Health Insurance Card (EHIC). Medically fit to fly after a JAR FCL3 - Class 2 examination Exclusion Criteria before the flight positive pregnancy test on flight day anxiety non-participation in flight safety briefing Exclusion Criteria during the flight failure to follow safety guidelines occurence of motion sickness during the procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A simulation study, in which participants alternatively perform oro-tracheal intubation on a manikin, either using a videolaryngoscope (McGrath model, Medtronic TM) or a direct laryngoscope
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Direct laryngoscopy in the ice-pick position<br>In this arm, participants are assigned to intubations attempts in weightlessness on a manikin. The insertion of a 7.0 mm cuffed oro-tracheal tube was performed by using a direct laryngoscope with a Macintosh non-angulated size 3 blade, in a face-to-face or ice-pick position. | Device: Videolaryngoscopy / Direct Laryngoscopy<br>* First pass success analysis<br>|
| Experimental: Video-laryngoscopy in free-floating position<br>In this arm, participants are assigned to intubations attempts in weightlessness on a manikin. The insertion of a 7.0 mm cuffed oro-tracheal tube was performed by using a video laryngoscopy in a semi-free-floating position (McGrath model, Covidien™, Medtronic™). | Device: Videolaryngoscopy / Direct Laryngoscopy<br>* First pass success analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First pass success | Bi-pulmonary ventilation success was assessed by the intubating operator performing chest auscultation and by the measurement of a tidal volume on the mannequin's electronic sensors. Selective side intubation was considered as failure | 1 day (1 flight) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time | The duration (seconds) of each attempt was recorded and ended with vocal confirmation of tube placement from the intubating operator or at the end of the parabola | 1 day (1 flight) | 
| Confidence Score | A subjective score of confidence in the correct tube placement was recorded after each attempt and ranked from minus ten (complete certainty about failure) to plus ten (complete certainty about success). A score of zero was pronounced by the operator when he/she had maximum uncertainty about success or failure. | 1 day (1 flight) |