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A single-centre, randomised controlled pilot trial comparing performance of direct laryngoscopy versus videolaryngoscopy for endotracheal intubation in surgical patients (MAC-V trial)

A single-centre, randomised controlled pilot trial comparing performance of direct laryngoscopy versus videolaryngoscopy for endotracheal intubation in surgical patients (MAC-V trial)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615001267549
Acronym
MAC-V
Enrollment
106
Registered
2015-11-19
Start date
2016-04-28
Completion date
2017-06-15
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Approximately half of patients having general anaesthesia require endotracheal intubation to allow muscle relaxation, control ventilation or protect the airway. Historically, this has been achieved mostly by direct laryngoscopy with a laryngoscope. In the last 20 years, videolaryngoscopy has been used increasingly with many anaesthetists favouring its use. The two techniques are in widespread use and anaesthetists are expected to be familiar with both. There is increasing evidence that videolaryngoscopy provides superior view of the glottic opening. However, this is a surrogate endpoint and there seems to be a poor relationship between view and intubation success with many videolaryngoscopic devices. A large, pragmatic clinical trial powered for intubation success has never been performed. Current randomised control trials comparing these methods are small, use different endpoints, and specific populations, making results less generalisable. Furthermore meta analyses comparing these devices have rarely collected data relating to harm that could be consequent to their use. We believe the most meaningful endpoint to determine the performance of these devices is first pass intubation, that is, the first attempt to intubate being successful. This single-centre study aims to compare direct larygoscopy with videolaryngoscopy using first pass intubation success as the primary endpoint. We aim to test the feasibility of a large, multicentre effectiveness trial by recruiting 100 trial participants. We aim to compare the relative harms of the different laryngoscopic techniques. The results of this trial will provide improved guidance for current airway algorithms

Interventions

Patients will be randomised to be intubated using either a direct laryngoscopy or videolaryngoscopy. The intervention (intubation using either direct laryngoscopy or videolaryngoscopy) will be a single event utilising standard intubating techniques (induction of anaesthesia and muscle relaxation) at the start of surgery requiring intubation. The sole difference between the groups will be the laryngoscopy technique used. Duration of intervention will be less than 15 minutes

Sponsors

Auckland District Health Board
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult patient scheduled for surgery requiring asleep endotracheal intubation No contra-indication to direct laryngoscopy or videolaryngoscopy Laryngoscopy for endotracheal intubation is required

Exclusion criteria

Unable/ Unwilling to consent Known previous difficult intubation Emergency surgery Clinical scenarios where awake or asleep fibreoptic inbutation is the technique of choice Operating anaesthetist has performed less than 20 videolaryngoscopies

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 3, 2026