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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05303948
Enrollment
9
Registered
2022-03-31
Start date
2019-09-01
Completion date
2019-10-18
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation Complication, Intubation; Difficult or Failed

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.

Interventions

DEVICEVideolaryngoscopy / Direct Laryngoscopy

First pass success analysis

Sponsors

Centre National d'Etudes Spatiales
CollaboratorOTHER_GOV
Groupe Hospitalier de Bretagne Sud
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Intervention 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

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
First pass success1 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

MeasureTime frameDescription
Time1 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 Score1 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026