Airtraq Versus Fiberoptic for Awake Tracheal Intubation

NCT ID: NCT03539185

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-05-18

Brief Summary

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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.

Detailed Description

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Conditions

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Intubation;Difficult Awake Intubation Airway Complication of Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Non-inferiority trial. Alpha risk de 2,5%, Power 90 %
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Airtraq

Awake tracheal intubation using airtraq videolaryngoscope.

Group Type ACTIVE_COMPARATOR

Videolaryngoscope Airtraq

Intervention Type DEVICE

Awake orotracheal intubation with laryngeal nerve block and remifentanil sedation

Fiberoptic

Awake nasotracheal tracheal intubation using flexible fiberoptic bronchoscope.

Group Type ACTIVE_COMPARATOR

Fiberoptic bronchoscope

Intervention Type DEVICE

Awake nasotracheal intubation with laryngeal nerve block and remifentanil sedation

Interventions

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Videolaryngoscope Airtraq

Awake orotracheal intubation with laryngeal nerve block and remifentanil sedation

Intervention Type DEVICE

Fiberoptic bronchoscope

Awake nasotracheal intubation with laryngeal nerve block and remifentanil sedation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandre FRUGIER, Résident

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Hervé KAMGA, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Locations

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CHU de Caen

Caen, Normandy, France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 24891196 (View on PubMed)

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

Reference Type RESULT
PMID: 27276778 (View on PubMed)

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.

Reference Type RESULT
PMID: 25907462 (View on PubMed)

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.

Reference Type RESULT
PMID: 25963612 (View on PubMed)

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.

Reference Type RESULT
PMID: 15023129 (View on PubMed)

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.

Reference Type RESULT
PMID: 19719938 (View on PubMed)

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.

Reference Type RESULT
PMID: 16398385 (View on PubMed)

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.

Reference Type RESULT
PMID: 19496763 (View on PubMed)

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.

Reference Type RESULT
PMID: 17567358 (View on PubMed)

Other Identifiers

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2018-A00239-46

Identifier Type: -

Identifier Source: org_study_id

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