Airtraq Versus Fiberoptic for Awake Tracheal Intubation

Not Applicable

Completed

• Conditions: Awake Intubation; Airway Complication of Anesthesia; Intubation;Difficult
• Interventions: Device: Fiberoptic bronchoscope; Device: Videolaryngoscope Airtraq

• Registration Number: NCT03539185
• Lead Sponsor: University Hospital, Caen

Brief Summary

The airway management is a vital act in anesthesia. The gold standard technique for planned very difficult intubation is nasotracheal fiberoptic intubation. The success rate with this procedure is 98.8%. However, learning this technique is difficult and it's considered uncomfortable by patients and practitioners.

The Airtraq® videolaryngoscope is commonly used for difficult orotracheal intubation. Cases of awake intubation by Airtraq® have been described.

Furthermore, the French Society of Anesthesia-Resuscitation, in its last formalized expert recommendations (2017) on difficult intubation, proposes the use of video laryngoscopes as an alternative to the fiberoptic bronchoscope.

We propose a non-inferiority study evaluating the use of Airtraq® for the realization of a awake intubation compared to the gold standard (fiberoptic bronchoscope). This prospective randomized study should include 78 patients in two groups. The purpose of this study is to improve the comfort of patient and practitioner during an awake tracheal intubation, to facilitate the learning of the technique.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-12
• Study First Submitted QC: 2018-05-16
• Study First Posted: 2018-05-29
• Study Start: 2018-06-01
• Status Verified: 2020-05
• Primary Completion: 2020-05-18
• Study Completion: 2020-05-18
• Last Update Submitted: 2020-10-14
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Formal indication of awake intubation or patient with two criteria of difficult intubation and ventilation
• Major patient
• Patient able to understand oral and written information

Exclusion Criteria

• Mouth opening (inter-incisor distance) <16 mm does not allow insertion of the Airtraq® videolaryngoscope
• Surgery requires nasotracheal intubation
• Loco-regional anesthesia of larynx impossible

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fiberoptic	Fiberoptic bronchoscope	Awake nasotracheal tracheal intubation using flexible fiberoptic bronchoscope.
Airtraq	Videolaryngoscope Airtraq	Awake tracheal intubation using airtraq videolaryngoscope.

Primary Outcome Measures

Name	Time	Method
Success of orotracheal or nasotracheal intubation.	1 day	Defined by the visualization of the tube into the trachea through vocal cords and by the appearance of the capnogram

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction score	1 day	Analogue visual scale graduated from zero to ten. Zero is the worst imaginable satisfaction and 10 is the better imaginable satisfaction.
Length of the proceedings	1 day	Duration between the insertion of device and the appearance of capnogram
Operator satisfaction score	1 day	Analogue visual scale graduated from zero to ten. Zero is the worst imaginable satisfaction and 10 is the better imaginable satisfaction.
Number of intubation attempts	1 day
Rate of occurrence of adverse events	1 day	Coughing, desaturation, agitation

Trial Locations

Locations (1)

CHU de Caen; 🇫🇷 Caen, Normandie, France