Airtraq Versus Fiberoptic for Awake Tracheal Intubation

Study Overview
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Brief Summary
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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.

Official Title
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Airtraq Versus Fiberoptic for Awake Tracheal Intubation : A Randomised Non-inferiority Trial

Conditions
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Airway Complication of Anesthesia, Intubation;Difficult, Awake Intubation

Intervention / Treatment
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* Device: Videolaryngoscope Airtraq
* Device: Fiberoptic bronchoscope


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-inferiority trial. Alpha risk de 2,5%, Power 90 %
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Airtraq<br>Awake tracheal intubation using airtraq videolaryngoscope. | Device: Videolaryngoscope Airtraq<br>* Awake orotracheal intubation with laryngeal nerve block and remifentanil sedation<br>|
| Active Comparator: Fiberoptic<br>Awake nasotracheal tracheal intubation using flexible fiberoptic bronchoscope. | Device: Fiberoptic bronchoscope<br>* Awake nasotracheal intubation with laryngeal nerve block and remifentanil sedation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of orotracheal or nasotracheal intubation. | Defined by the visualization of the tube into the trachea through vocal cords and by the appearance of the capnogram | 1 day | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tracheal intubation, laryngeal nerve blocks, sedation, remifentanil, Airtraq, Fiberoptic, Awake