Evaluation of Two Positions for Free Floating Tracheal Intubation in Weightlessness

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

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.

Study Overview

• Status: Completed
• Conditions: Intubation Complication; Intubation; Difficult or Failed
• Intervention / Treatment: Device: Videolaryngoscopy / Direct Laryngoscopy

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lorient, France, 56100
    • Groupe Hospitalier de Bretagne Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Direct laryngoscopy in the ice-pick position; 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; First pass success analysis
Experimental: Video-laryngoscopy in free-floating position; 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; First pass success analysis

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Groupe Hospitalier de Bretagne Sud
• Collaborators: Centre National d'Etudes Spatiales
• Investigators: Principal Investigator: Séamus Thierry, MD, Groupe Hospitalier de Bretagne Sud

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): October 18, 2019
• Study Completion (Actual): October 18, 2019

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2019-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All relevant data, anonymized, will be available from Dr S.Thierry on request
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No