Evaluation of Two Positions for Free Floating Tracheal Intubation in Weightlessness

Not Applicable

Completed

• Conditions: Intubation; Difficult or Failed; Intubation Complication
• Interventions: Device: Videolaryngoscopy / Direct Laryngoscopy

• Registration Number: NCT05303948
• Lead Sponsor: Groupe Hospitalier de Bretagne Sud

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2019-10-18
• Study Completion: 2019-10-18
• Study First Submitted: 2022-02-22
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-21
• Last Update Submitted: 2022-03-21
• Study First Posted: 2022-03-31
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Video-laryngoscopy in free-floating position	Videolaryngoscopy / Direct Laryngoscopy	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™).
Direct laryngoscopy in the ice-pick position	Videolaryngoscopy / Direct Laryngoscopy	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.

Primary Outcome Measures

Name	Time	Method
First pass success	1 day (1 flight)	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

Secondary Outcome Measures

Name	Time	Method
Time	1 day (1 flight)	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
Confidence Score	1 day (1 flight)	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.

Trial Locations

Locations (1)

Groupe Hospitalier de Bretagne Sud; 🇫🇷 Lorient, France