Comparison of Two Videolaryngoscopes (C-MAC vs Airtraq) for Awake Intubation

NCT ID: NCT05428995

Last Updated: 2024-01-23

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-15

Study Completion Date

2024-01-19

Brief Summary

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Patients with anticipated difficult airway are recommended to be managed with an awake tracheal intubation. Initially fibreoptic bronchoscopy was considered the gold standard, but in the last decade videolaryngoscopes have been demonstrated to be an efficacy alternative technique. Recently, a systematic review and meta-analysis was published investigating the efficacy and safety of videolaryngoscopy compared with fibreoptic bronchoscopy for awake tracheal intubation. Eight prospective, randomized studies were included, with different videolaryngoscopes (C-MAC, GlideScope, Pentax AWS, McGraft, and Bullard). However, a direct comparison of two different videolaryngoscopes for awake tracheal intubation in patients with anticipated difficult airway has not been performed.

Detailed Description

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This is a clinical prospective randomized-controlled trial. The aim of this study is to compare two different devices (C-MAC videolaryngoscope and Airtraq videolaryngoscope) for awake tracheal intubation in patients with difficult airways scheduled for surgery. The primary endpoint will be to compare first-attempt intubation success rate between the two videolaryngoscopes. Secondary outcomes will be to compare: difference in the overall success rate, number of intubation attempts, Cormack-Lehane grade of glottic view, incidence of complications related to intubation, difficulty experienced by the operator, patient's tolerability of the procedure.

Conditions

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Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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C-MAC videolaryngoscope

Patients with anticipated difficult airway will be awake intubated with a C-MAC videolaryngoscopy. Spontaneous breathing will be preserved, and the same protocol of sedation plus upper airways topical anesthesia will be applied in both groups.

Group Type ACTIVE_COMPARATOR

C-MAC videolaryngoscope

Intervention Type DEVICE

Patients with anticipated difficult airway will be awake intubated with a C-MAC videolaryngoscopy

Airtraq videolaryngoscope

Patients with anticipated difficult airway will be awake intubated with a Airtraq videolaryngoscopy. Spontaneous breathing will be preserved, and the same protocol of sedation plus upper airways topical anesthesia will be applied in both groups.

Group Type ACTIVE_COMPARATOR

Airtraq videolaryngoscope.

Intervention Type DEVICE

Patients with anticipated difficult airway will be awake intubated with a Airtraq videolaryngoscopy

Interventions

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C-MAC videolaryngoscope

Patients with anticipated difficult airway will be awake intubated with a C-MAC videolaryngoscopy

Intervention Type DEVICE

Airtraq videolaryngoscope.

Patients with anticipated difficult airway will be awake intubated with a Airtraq videolaryngoscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years and older
* Patients with anticipated difficult airway requiring awake intubation under local anaesthesia and conscious sedation for general anesthesia.
* Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.

Exclusion Criteria

* Pregnancy
* age \<18 years
* refusal of the patient
* patient's respiratory failure
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinico Universitario de Santiago

OTHER

Sponsor Role lead

Responsible Party

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Manuel Taboada Muñiz

Professor University Of Santiago de Compostela

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manuel Taboada Muñiz, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Clinical Hospital of Santiago de Compostela

Locations

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University Clinical Hospital of Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Site Status

Countries

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Spain

References

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Alhomary M, Ramadan E, Curran E, Walsh SR. Videolaryngoscopy vs. fibreoptic bronchoscopy for awake tracheal intubation: a systematic review and meta-analysis. Anaesthesia. 2018 Sep;73(9):1151-1161. doi: 10.1111/anae.14299. Epub 2018 Apr 17.

Reference Type BACKGROUND
PMID: 29687891 (View on PubMed)

Lewis SR, Butler AR, Parker J, Cook TM, Smith AF. Videolaryngoscopy versus direct laryngoscopy for adult patients requiring tracheal intubation. Cochrane Database Syst Rev. 2016 Nov 15;11(11):CD011136. doi: 10.1002/14651858.CD011136.pub2.

Reference Type BACKGROUND
PMID: 27844477 (View on PubMed)

Moore A, Schricker T. Awake videolaryngoscopy versus fiberoptic bronchoscopy. Curr Opin Anaesthesiol. 2019 Dec;32(6):764-768. doi: 10.1097/ACO.0000000000000771.

Reference Type BACKGROUND
PMID: 31356364 (View on PubMed)

Moore AR, Schricker T, Court O. Awake videolaryngoscopy-assisted tracheal intubation of the morbidly obese. Anaesthesia. 2012 Mar;67(3):232-5. doi: 10.1111/j.1365-2044.2011.06979.x.

Reference Type BACKGROUND
PMID: 22321077 (View on PubMed)

Other Identifiers

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AWAKE-CMAC-AIRTRAQ

Identifier Type: -

Identifier Source: org_study_id

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