Clinical trial NCT03539185: Airtraq Versus Fiberoptic for Awake Tracheal Intubation
Official title: Airtraq Versus Fiberoptic for Awake Tracheal Intubation : A Randomised Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation;Difficult
Awake Intubation
Airway Complication of Anesthesia
Keywords: Airtraq
Fiberoptic
Awake
Tracheal intubation
laryngeal nerve blocks
sedation
remifentanil
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2018-05-29
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferiority trial. Alpha risk de 2,5%, Power 90 %
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Success of orotracheal or nasotracheal intubation.
timeFrame: 1 day
Secondary outcomes:
measure: Length of the proceedings
timeFrame: 1 day
measure: Rate of occurrence of adverse events
timeFrame: 1 day
measure: Patient satisfaction score
timeFrame: 1 day
measure: Operator satisfaction score
timeFrame: 1 day
measure: Number of intubation attempts
timeFrame: 1 day
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen
state: Normandie
Study officials:
affiliation: University Hospital, Caen
name: Alexandre FRUGIER, Résident
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Caen
name: Hervé KAMGA, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Collins SR, Blank RS. Fiberoptic intubation: an overview and update. Respir Care. 2014 Jun;59(6):865-78; discussion 878-80. doi: 10.4187/respcare.03012.
citation: Pintaric TS. UPPER AIRWAY BLOCKS FOR AWAKE DIFFICULT AIRWAY MANAGEMENT. Acta Clin Croat. 2016 Mar;55 Suppl 1:85-9.
citation: Law JA, Morris IR, Brousseau PA, de la Ronde S, Milne AD. The incidence, success rate, and complications of awake tracheal intubation in 1,554 patients over 12 years: an historical cohort study. Can J Anaesth. 2015 Jul;62(7):736-44. doi: 10.1007/s12630-015-0387-y. Epub 2015 Apr 24.
citation: Law JA, Morris IR, Milne AD. The complications of awake tracheal intubation. Can J Anaesth. 2015 Sep;62(9):1023. doi: 10.1007/s12630-015-0402-3. Epub 2015 May 12. No abstract available.
citation: Allan AG. Reluctance of anaesthetists to perform awake intubation. Anaesthesia. 2004 Apr;59(4):413. doi: 10.1111/j.1365-2044.2004.03729.x. No abstract available.
citation: Xu YC, Xue FS, Luo MP, Yang QY, Liao X, Liu Y, Zhang YM. Median effective dose of remifentanil for awake laryngoscopy and intubation. Chin Med J (Engl). 2009 Jul 5;122(13):1507-12.
citation: Dawson AJ, Marsland C, Baker P, Anderson BJ. Fibreoptic intubation skills among anaesthetists in New Zealand. Anaesth Intensive Care. 2005 Dec;33(6):777-83. doi: 10.1177/0310057X0503300613.
citation: Dimitriou VK, Zogogiannis ID, Liotiri DG. Awake tracheal intubation using the Airtraq laryngoscope: a case series. Acta Anaesthesiol Scand. 2009 Aug;53(7):964-7. doi: 10.1111/j.1399-6576.2009.02012.x. Epub 2009 Jun 3.
citation: Suzuki A, Toyama Y, Iwasaki H, Henderson J. Airtraq for awake tracheal intubation. Anaesthesia. 2007 Jul;62(7):746-7. doi: 10.1111/j.1365-2044.2007.05155.x. No abstract available.