Evaluation of Two Positions for Free Floating Tracheal Intubation in Weightlessness

Groupe Hospitalier de Bretagne Sud

Status: Completed

Conditions: Intubation Complication; Intubation; Difficult or Failed

Treatments: Device: Videolaryngoscopy / Direct Laryngoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT05303948

2019-1

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Direct laryngoscopy in the ice-pick position

Experimental group

Description:

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.

Treatment:

Device: Videolaryngoscopy / Direct Laryngoscopy

Video-laryngoscopy in free-floating position

Experimental group

Description:

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™).

Treatment:

Device: Videolaryngoscopy / Direct Laryngoscopy