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IntubationAWAKECMACTRANCT05428995

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

A study testing C-MAC videolaryngoscope and Airtraq videolaryngoscope. in people with Intubation, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Intubation
What is being tested?
C-MAC videolaryngoscope and Airtraq videolaryngoscope.
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteSpain
Study dates
15 Jun 2022to 19 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Pregnancy
  • age <18 years
  • refusal of the patient
  • patient's respiratory failure

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University Clinical Hospital of Santiago de Compostela

    Santiago de Compostela, A Coruña, 15866

Other trials in Spain

About this study

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

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.

Read the detailed 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.

Conditions
Intubation
Being tested
C-MAC videolaryngoscope, Airtraq videolaryngoscope.
Keywords
intubation, difficult airway, videolaryngoscope

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • C-MAC videolaryngoscopeDevice

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

  • Airtraq videolaryngoscope.Device

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

Study groups in NCT05428995
Study groupRoleWhat they receive
C-MAC videolaryngoscopeActive comparatorPatients 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.
Receives: Device: C-MAC videolaryngoscope
Airtraq videolaryngoscopeActive comparatorPatients 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.
Receives: Device: Airtraq videolaryngoscope.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: during intubation

Secondary outcomes (7)

  1. Difference in the overall success rate (percentage)

    To compare the difference overall success rate (percentage) with the two awake videolaryngoscope techniques for tracheal intubation.

    Measured: during intubation

  2. Number of intubation attempts

    To compare number of intubations attempts with the two awake videolaryngoscope techniques.

    Measured: during intubation

  3. Cormack-Lehane grade of glottic view

    To compare Cormack-Lehane grade of glottic view with the two awake videolaryngoscope techniques for tracheal intubation.

    Measured: during intubation

  4. 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

    Measured: Participants will be followed from the beginning of the intervention to 30 minutes after the intervention

  5. 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

    Measured: during intubation

  6. 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

    Measured: during intubation

  7. 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

    Measured: 24 hours after intubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2022
  2. Study start15 Jun 2022
  3. Primary completion19 Jan 2024
  4. Study completion19 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05428995
Sponsor's protocol ID
AWAKE-CMAC-AIRTRAQ
Acronym
AWAKECMACTRA
Status last verified
Jul 2023
First submitted
15 Jun 2022
Last updated
23 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified participant data How to access data: Requests must be sent to manutabo@yahoo.es When available: With publication Additional Information Who can access the data: Researchers whose proposed use of the data has been approved Types of analyses: For scientific purpose Mechanisms of data availability: With investigator support

Publications

  • 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.

    PubMed 29687891

  • 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.

    PubMed 27844477

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

    PubMed 31356364

  • 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.

    PubMed 22321077

Questions about this trial

What is this clinical trial studying?

A study testing C-MAC videolaryngoscope and Airtraq videolaryngoscope. in people with Intubation, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in the first attempt intubation success rate (percentage) (time frame: during intubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05428995, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.

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