Airtraq Versus Fiberoptic for Awake Tracheal Intubation

NCT03539185 | Completed

• 1 other identifier: 2018-A00239-46
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation;Difficult; Awake Intubation; Airway Complication of Anesthesia

Keywords

Airtraq; Fiberoptic; Awake; Tracheal intubation; laryngeal nerve blocks; sedation; remifentanil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Length of the proceedings

  1 day

• Rate of occurrence of adverse events

  1 day

• Patient satisfaction score

  1 day

• Operator satisfaction score

  1 day

• Number of intubation attempts

  1 day

Study Arms (2)

Airtraq

ACTIVE COMPARATOR

Awake tracheal intubation using airtraq videolaryngoscope.

Device: Videolaryngoscope Airtraq

Fiberoptic

ACTIVE COMPARATOR

Awake nasotracheal tracheal intubation using flexible fiberoptic bronchoscope.

Device: Fiberoptic bronchoscope

Interventions

Videolaryngoscope Airtraq DEVICE

Awake orotracheal intubation with laryngeal nerve block and remifentanil sedation

Airtraq

Fiberoptic bronchoscope DEVICE

Awake nasotracheal intubation with laryngeal nerve block and remifentanil sedation

Fiberoptic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU de Caen

Caen, Normandy, 14000, France

Location

Related Publications (9)

• 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.

  PMID: 24891196 RESULT

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

  PMID: 27276778 RESULT

• 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.

  PMID: 25907462 RESULT

• 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.

  PMID: 25963612 RESULT

• 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.

  PMID: 15023129 RESULT

• 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.

  PMID: 19719938 RESULT

• 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.

  PMID: 16398385 RESULT

• 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.

  PMID: 19496763 RESULT

• 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.

  PMID: 17567358 RESULT

Study Officials

• Alexandre FRUGIER, Résident

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

• Hervé KAMGA, Dr

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-inferiority trial. Alpha risk de 2,5%, Power 90 %

Study Record Dates

• First Submitted: May 12, 2018
• First Posted: May 29, 2018
• Study Start: June 1, 2018
• Primary Completion: May 18, 2020
• Study Completion: May 18, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-05

Locations

FR (1)