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

Intubation Clinical Trial

— AWAKECMACTRA  

Official title:

A Randomized Comparison Between the C-MAC and Airtraq Videolaryngoscopes for First-attempt Intubation Success in Awake Patients With Anticipated Difficult Airway.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05428995
• Other study ID #: AWAKE-CMAC-AIRTRAQ
• Status: Completed
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: January 19, 2024

Study information

• Verified date: July 2023
• Source: Hospital Clinico Universitario de Santiago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 19, 2024
• Est. primary completion date: January 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation

Intervention

Device:
• C-MAC videolaryngoscope
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

Locations

Country	Name	City	State
Spain	University Clinical Hospital of Santiago de Compostela	Santiago de Compostela	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinico Universitario de Santiago

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the first attempt intubation success rate (percentage)	To compare the difference in the first attempt success rate (percentage) of different awake videolaryngoscope techniques for tracheal intubation.	during intubation
Secondary	Difference in the overall success rate (percentage)	To compare the difference overall success rate (percentage) with the two awake videolaryngoscope techniques for tracheal intubation.	during intubation
Secondary	Number of intubation attempts	To compare number of intubations attempts with the two awake videolaryngoscope techniques.	during intubation
Secondary	Cormack-Lehane grade of glottic view	To compare Cormack-Lehane grade of glottic view with the two awake videolaryngoscope techniques for tracheal intubation.	during intubation
Secondary	Difference in the incidence of complications related to intubation (percentage)	To compare the difference in complications (percentage) with the two awake videolaryngoscope techniques. Hypoxemia (SpO2) < 90 %, Hypoxemia severe (SpO2) < 80 %, Hypotension defined as systolic blood pressure less than 80 mm Hg Severe hypotension defined as systolic blood pressure less than 65 mm Hg Cardiac arrest, death during intubation Moderate or difficult intubation esophageal intubation pulmonary aspiration, dental injuries Oral-pharynx and larynx traumatism	Participants will be followed from the beginning of the intervention to 30 minutes after the intervention
Secondary	Degree of subjective difficulty experienced by the operator	Operator-assessed subjective difficulty of intubation by means of a special analogue numerical scale from 0 to 10, where 0=no subjective difficulty and 10=maximal subjective difficulty	during intubation
Secondary	Degree of subjective patient's tolerability of the procedure	Operator-assessed subjective patient's tolerance of the procedure by means of a special analogue numerical scale from 0 to 10, where 0=very good subjective tolerance and 10=very bad subjective tolerance	during intubation
Secondary	Degree of patient's confort of the procedure	During the postoperative visit on the following day (24 hours after intubation), patient will be asked to rate their confort during the procedure by means of a special analogue numerical scale from 0 to 10, where 0=very good tolerance and 10=worst possible discomfort	24 hours after intubation