Airtraq Versus Fiberoptic for Awake Tracheal Intubation

Intubation;Difficult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03539185
• Other study ID #: 2018-A00239-46
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: May 18, 2020

Study information

• Verified date: May 2020
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 18, 2020
• Est. primary completion date: May 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Complication of Anesthesia
• Awake Intubation
• Intubation;Difficult

Intervention

Device:
• Videolaryngoscope Airtraq
Awake orotracheal intubation with laryngeal nerve block and remifentanil sedation
• Fiberoptic bronchoscope
Awake nasotracheal intubation with laryngeal nerve block and remifentanil sedation

Locations

Country	Name	City	State
France	CHU de Caen	Caen	Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

References & Publications (9)

Allan AG. Reluctance of anaesthetists to perform awake intubation. Anaesthesia. 2004 Apr;59(4):413. — View 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. Review. — View 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. — View 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. — View 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/s12630-01 — View 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. — View Citation

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

Suzuki A, Toyama Y, Iwasaki H, Henderson J. Airtraq for awake tracheal intubation. Anaesthesia. 2007 Jul;62(7):746-7. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of the proceedings	Duration between the insertion of device and the appearance of capnogram	1 day
Secondary	Rate of occurrence of adverse events	Coughing, desaturation, agitation	1 day
Secondary	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
Secondary	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
Secondary	Number of intubation attempts		1 day