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Completed

NCT Number: NCT05303948

Evaluation of Two Positions for Free Floating Tracheal Intubation in Weightlessness

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.

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Key information

Conditions

Intubation; Difficult or Failed Intubation Complication

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier de Bretagne Sud

Lorient, 56100, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Videolaryngoscopy / Direct Laryngoscopy

Device

First pass success analysis

Primary outcomes

  1. First pass success

    Time frame: 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 outcomes

  1. Time

    Time frame: 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

  2. Confidence Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de Bretagne Sud

Other

Collaborators

  • Centre National d'Etudes Spatiales

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 31, 2022
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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