Airtraq Versus Fiberoptic for Awake Tracheal Intubation
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|ClinicalTrials.gov Identifier: NCT03539185|
Recruitment Status : Completed
First Posted : May 29, 2018
Last Update Posted : October 19, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Intubation;Difficult Awake Intubation Airway Complication of Anesthesia||Device: Videolaryngoscope Airtraq Device: Fiberoptic bronchoscope||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Non-inferiority trial. Alpha risk de 2,5%, Power 90 %|
|Masking:||None (Open Label)|
|Official Title:||Airtraq Versus Fiberoptic for Awake Tracheal Intubation : A Randomised Non-inferiority Trial|
|Actual Study Start Date :||June 1, 2018|
|Actual Primary Completion Date :||May 18, 2020|
|Actual Study Completion Date :||May 18, 2020|
Active Comparator: Airtraq
Awake tracheal intubation using airtraq videolaryngoscope.
Device: Videolaryngoscope Airtraq
Awake orotracheal intubation with laryngeal nerve block and remifentanil sedation
Active Comparator: Fiberoptic
Awake nasotracheal tracheal intubation using flexible fiberoptic bronchoscope.
Device: Fiberoptic bronchoscope
Awake nasotracheal intubation with laryngeal nerve block and remifentanil sedation
- Success of orotracheal or nasotracheal intubation. [ Time Frame: 1 day ]Defined by the visualization of the tube into the trachea through vocal cords and by the appearance of the capnogram
- Length of the proceedings [ Time Frame: 1 day ]Duration between the insertion of device and the appearance of capnogram
- Rate of occurrence of adverse events [ Time Frame: 1 day ]Coughing, desaturation, agitation
- Patient satisfaction score [ Time Frame: 1 day ]Analogue visual scale graduated from zero to ten. Zero is the worst imaginable satisfaction and 10 is the better imaginable satisfaction.
- Operator satisfaction score [ Time Frame: 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 [ Time Frame: 1 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539185
|CHU de Caen|
|Caen, Normandie, France, 14000|
|Principal Investigator:||Alexandre FRUGIER, Résident||University Hospital, Caen|
|Principal Investigator:||Hervé KAMGA, Dr||University Hospital, Caen|