Evaluation of Two Positions for Free Floating Tracheal Intubation in Weightlessness

Intubation Complication Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05303948
• Other study ID #: 2019-1
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: October 18, 2019

Study information

• Verified date: March 2022
• Source: Groupe Hospitalier de Bretagne Sud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 18, 2019
• Est. primary completion date: October 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation Complication
• Intubation; Difficult or Failed

Intervention

Device:
• Videolaryngoscopy / Direct Laryngoscopy
First pass success analysis

Locations

Country	Name	City	State
France	Groupe Hospitalier de Bretagne Sud	Lorient

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Hospitalier de Bretagne Sud	Centre National d'Etudes Spatiales

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)