Airtraq Versus Fiberoptic for Awake Tracheal Intubation

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

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.

Study Overview

• Status: Completed
• Conditions: Airway Complication of Anesthesia; Intubation;Difficult; Awake Intubation
• Intervention / Treatment: Device: Videolaryngoscope Airtraq; Device: Fiberoptic bronchoscope

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Normandie
    • Caen, Normandie, France, 14000
      • CHU de Caen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: Alexandre FRUGIER, Résident, University Hospital, Caen; Principal Investigator: Hervé KAMGA, Dr, University Hospital, Caen

Publications and helpful links

General Publications

• 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.
• Pintaric TS. UPPER AIRWAY BLOCKS FOR AWAKE DIFFICULT AIRWAY MANAGEMENT. Acta Clin Croat. 2016 Mar;55 Suppl 1:85-9.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): May 18, 2020
• Study Completion (Actual): May 18, 2020

Study Registration Dates

• First Submitted: May 12, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 14, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: sedation; Fiberoptic; remifentanil; Tracheal intubation; Airtraq; Awake; laryngeal nerve blocks
• Other Study ID Numbers: 2018-A00239-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No