ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615001267549

Ethics application status

Approved

Date submitted

12/11/2015

Date registered

19/11/2015

Date last updated

7/05/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

nil known

Universal Trial Number (UTN)

U1111-1176-3641

Trial acronym

MAC-V

Linked study record

Health condition

Health condition(s) or problem(s) studied:

patients undergoing surgery who require endotracheal intubation

Condition category

Condition code

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Direct laryngoscopy

Control group

Active

Outcomes

Primary outcome [1]

Incidence of first pass endotracheal intubation. A successful first-pass intubation was defined as a fluid movement from when the endotracheal tube enters the mouth to when it has been positioned during the vocal cords during a single apnoeic episode. Airway adjuncts such as bougie or stylet may be used as could assistance with optimal external laryngeal manipulation (OELM) or suctioning but these must be performed prior the the endotracheal tube entering the patient’s oropharynx. Curtailing the attempt for bag-mask ventilation, repositioning, assistance or additional equipment to those already specified was deemed failure. Attempting to pass the tube multiple times (more than twice without success) without adjusting the laryngoscope was also deemed as unsuccessful.

Timepoint [1]

at intervention

Secondary outcome [1]

Time to first pass endotracheal intubation.
Time to first-pass intubation is defined as the time taken from when the intubator takes the laryngoscope to when endotracheal tube placement is confirmed and end tidal CO2 is recorded on capnography waveform. This will be timwed using a stopwatch.

Timepoint [1]

at intervenion. This is from when the intubator takes the laryngoscope to when endotracheal tube placement is confirmed and end tidal CO2 is recorded on capnography waveform. Please see specific definition above.

Secondary outcome [2]

performance of techniques measured by intubation difficulty score (IDS)

Timepoint [2]

immediately following intervention

Secondary outcome [3]

patient harm measured by composite of airway bleeding, mucosal injury and dental damage reported in post anaesthetic care uint

Timepoint [3]

immediately after intervention

Eligibility

Key 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

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key 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

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Those meeting inclusion criteria and lacking exclusion criteria will be invited to participate in the study.
Following provision of informed consent subjects will be allocated to one of the two treatment groups . Group assignment will be by random concealed allocation, this will be carried out using sealed opaque envelopes.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

We estimate a total of 100 patients will be adequate to test feasibility endpoints but not adequate for the primary endpoint. We estimate from previously published data that the first-pass intubation rates will be approximately 85%. We believe a clinically important absolute difference would be 5%.
To find a 5% absolute difference between the performances of laryngoscopy blades we calculated that the sample size of 1480 (alpha= 0.05 and beta= 0.2) or 1940 (alpha=0.05 and beta 0.1) would be needed. Please refer to table in attachments section on page 9 to see calculations.
Responses will be collected and collated using Microsoft Excel and statistical analysis will be carried out using SAS v9.3 for Windows. Categorical variables will be compared using the X^2 analysis; and continuous variables using Students t-test or ANOVA for normally distributed variables; non-normally distributed variables will be transformed or analysed using non-parametric statistics as appropriate.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

11/01/2016

Actual

28/04/2016

Date of last participant enrolment

Anticipated

Actual

15/06/2017

Date of last data collection

Anticipated

Actual

31/08/2017

Sample size

Target

100

Accrual to date

Final

106

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Auckland District Health Board

Address [1]

Department of Anaesthesia
Level 8 Support Building
Auckland City Hospital
2 Park Road, Grafton
Auckland
1023

Country [1]

New Zealand

Primary sponsor type

Government body

Name

Auckland District Health Board

Address

Department of Anaesthesia
Level 8 Support Building
Auckland City Hospital
2 Park Road, Grafton
Auckland
1023

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

12/11/2015

Approval date [1]

27/01/2016

Ethics approval number [1]

Summary

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

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/369575-Study design.docx

Contacts

Principal investigator

Name

Dr Alice Loughnan

Address

Department of Anaesthesia
Level 8 Support Building
Auckland City Hospital
2 Park Road, Grafton
Auckland
1023

Country

New Zealand

Phone

+6493670000

Fax

alice.loughnan@btinternet.com

Contact person for public queries

Name

Davina Mcallister

Address

Department of Anaesthesia
Level 8 Support Building
Auckland City Hospital
2 Park Road, Grafton
Auckland
1023

Country

New Zealand

Phone

+6493757095

Fax

davinams@adhb.govt.nz

Contact person for scientific queries

Name

Douglas Campbell

Address

Department of Anaesthesia
Level 8 Support Building
Auckland City Hospital
2 Park Road, Grafton
Auckland
1023

Country

New Zealand

Phone

+6493670000

Fax

dcampbell@adhb.govt.nz

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A single-centre, randomised controlled feasibility pilot trial comparing performance of direct laryngoscopy versus videolaryngoscopy for endotracheal intubation in surgical patients.	2019	https://dx.doi.org/10.1186/s40814-019-0433-6

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically