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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05303948
Other study ID # 2019-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
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