Evaluation of Two Positions for Free Floating Tracheal Intubation in Weightlessness

NCT05303948 | Completed

• 1 other identifier: 2019-1
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation; Difficult or Failed; Intubation Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time

  1 day (1 flight)

• Confidence Score

  1 day (1 flight)

Study Arms (2)

Direct laryngoscopy in the ice-pick position

EXPERIMENTAL

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

Video-laryngoscopy in free-floating position

EXPERIMENTAL

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

Interventions

Videolaryngoscopy / Direct Laryngoscopy DEVICE

First pass success analysis

Direct laryngoscopy in the ice-pick position; Video-laryngoscopy in free-floating position

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• positive pregnancy test on flight day
• anxiety
• non-participation in flight safety briefing
• failure to follow safety guidelines
• occurence of motion sickness during the procedure

Sponsors & Collaborators

• Groupe Hospitalier de Bretagne Sud: lead
• Centre National d'Etudes Spatiales: collaborator

Study Sites (1)

Groupe Hospitalier de Bretagne Sud

Lorient, 56100, France

Location

Related Publications (1)

• Thierry S, Jaulin F, Starck C, Aries P, Schmitz J, Kerkhoff S, Bernard CI, Komorowski M, Warnecke T, Hinkelbein J. Evaluation of free-floating tracheal intubation in weightlessness via ice-pick position with a direct laryngoscopy and classic approach with indirect videolaryngoscopy. NPJ Microgravity. 2023 Sep 8;9(1):73. doi: 10.1038/s41526-023-00314-y.

  PMID: 37684267 DERIVED

Study Officials

• Séamus Thierry, MD

  Groupe Hospitalier de Bretagne Sud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist and Intensive Care Doctor

Model Details: 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

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 31, 2022
• Study Start: September 1, 2019
• Primary Completion: October 18, 2019
• Study Completion: October 18, 2019
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

FR (1)