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Evaluation of Two Positions for Free Floating Tracheal Intubation in Weightlessness

NCT ID: NCT05303948

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2019-10-18

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.

Detailed Description

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Conditions

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Intubation; Difficult or Failed Intubation Complication

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Videolaryngoscopy / Direct Laryngoscopy

Intervention Type DEVICE

First pass success analysis

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™).

Group Type EXPERIMENTAL

Videolaryngoscopy / Direct Laryngoscopy

Intervention Type DEVICE

First pass success analysis

Interventions

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Videolaryngoscopy / Direct Laryngoscopy

First pass success analysis

Intervention Type DEVICE

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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre National d'Etudes Spatiales

OTHER_GOV

Sponsor Role collaborator

Groupe Hospitalier de Bretagne Sud

OTHER

Sponsor Role lead

Responsible Party

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Dr Seamus Thierry

Anesthesiologist and Intensive Care Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Séamus Thierry, MD

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier de Bretagne Sud

Locations

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Groupe Hospitalier de Bretagne Sud

Lorient, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 37684267 (View on PubMed)

Other Identifiers

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2019-1

Identifier Type: -

Identifier Source: org_study_id