Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000066381
Ethics application status
Not yet submitted
Date submitted
3/02/2008
Date registered
6/02/2008
Date last updated
8/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of McCoy and Airtraq Laryngoscopes in Patients with Cervical Spine Immobilisation
Scientific title
Comparison of McCoy and Airtraq laryngoscopes with respect to intubation time and intubation difficulty scale (IDS) scores in patients with cervical spine immobilisation
Secondary ID [1] 288093 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical spine immobilisation 2788 0
Condition category
Condition code
Anaesthesiology 2924 2924 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single tracheal intubation using the Airtraq laryngoscope. The process of intubation involves placing a breathing tube in the 'windpipe' and it occurs after the patient is anaesthetised. The intubation procedure takes less than 2 minutes to complete. Intubation is usually aided by a device called a laryngoscope, which is placed in the patient's mouth. The Airtraq is a novel, single-use optical laryngoscope with a number of design features that suggest its utility in the setting of cervical spine immobilisation.
Intervention code [1] 2531 0
Treatment: Devices
Comparator / control treatment
A single tracheal intubation using the McCoy laryngoscope. The process of intubation involves placing a breathing tube in the 'windpipe' and it occurs after the patient is anaesthetised. The intubation procedure takes less than 2 minutes to complete. Intubation is usually aided by a device called a laryngoscope, which is placed in the patient's mouth. The McCoy laryngoscope is a standard anaesthetic tool with an established place in the airway management of patients with immobilised cervical spines.
Control group
Active

Outcomes
Primary outcome [1] 3803 0
Intubation time
Timepoint [1] 3803 0
at time of tracheal intubation
Primary outcome [2] 3804 0
Intubation Difficulty Scale (IDS) score
Timepoint [2] 3804 0
at time of tracheal intubation
Secondary outcome [1] 6414 0
Rate of successful placement of the tracheal tube
Timepoint [1] 6414 0
at the time of tracheal intubation
Secondary outcome [2] 6415 0
Cormack & Lehane grade at laryngoscopy
Timepoint [2] 6415 0
at time of laryngoscopy
Secondary outcome [3] 6416 0
Number of intubation attempts
Timepoint [3] 6416 0
at the time of tracheal intubation
Secondary outcome [4] 6417 0
Number of optimisation manoeuvres required to aid tracheal intubation
Timepoint [4] 6417 0
at time of tracheal intubation

Eligibility
Key inclusion criteria
Adult patients (American Society of Anesthesiologists Physical Status 1 & 2) presenting for elective surgery requiring tracheal intubation
Minimum age
18 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients with a past history of difficult tracheal intubation, or with clinical signs of potential difficulty with tracheal intubation

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)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur according to a sealed envelope selection process
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
3/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 755 0
4029

Funding & Sponsors
Funding source category [1] 3050 0
Hospital
Name [1] 3050 0
Royal Brisbane and Women's Hospital
Country [1] 3050 0
Australia
Primary sponsor type
Individual
Name
Dr Michael Bishop
Address
Department of Anaesthesia and Perioperative Medicine, Royal Brisbane and Women's Hospital, Butterfield Street, Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 2748 0
None
Name [1] 2748 0
Address [1] 2748 0
Country [1] 2748 0
Other collaborator category [1] 192 0
Individual
Name [1] 192 0
Dr Linda Beckmann
Address [1] 192 0
Department of Anaesthesia and Perioperative Medicine, Royal Brisbane and Women's Hospital, Butterfield Street, Herston QLD 4029
Country [1] 192 0
Australia
Other collaborator category [2] 193 0
Individual
Name [2] 193 0
Dr Keith Greenland
Address [2] 193 0
Wesley Anaesthesia and Pain Management Group, Wesley Medical Centre, 40 Chasely Street, Auchenflower QLD 4066
Country [2] 193 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5001 0
Royal Brisbane and Women's Health Service District Human Research Ethics Committee
Ethics committee address [1] 5001 0
Level 7, Block 7, Royal Brisbane and Women's Hospital, Butterfield Street, Herston QLD 4029
Ethics committee country [1] 5001 0
Australia
Date submitted for ethics approval [1] 5001 0
15/11/2007
Approval date [1] 5001 0
Ethics approval number [1] 5001 0

Summary
Brief summary
Failure to immobilise the neck during tracheal intubation in patients with cervical spine injuries (CSI) can result in a devastating neurologic outcome. One method to immobilise the neck during laryngoscopy and tracheal intubation is manual in-line neck stabilisation (MILNS). With MILNS, however, it is often more difficult to visualise the larynx using conventional laryngoscopy. Consequently, the application of MILNS may result in failure to secure the airway, which may result in substantial morbidity or even mortality. These issues highlight the need to develop alternative approaches to securing the airway in patients with CSI.

The purpose of the proposed study is to compare the performance of the Airtraq and McCoy laryngoscopes for tracheal intubation in patients with cervical spine immobilisation using MILNS. The McCoy laryngoscope, introduced into clinical practice in 1993, is a modification of the standard Macintosh blade. It is a familiar anaesthetic tool with an established place in the airway management of patients with immobilised cervical spines. The Airtraq, in contrast, is a novel intubation device. It is a single-use optical laryngoscope with a number of design features that suggest its utility in the setting of cervical spine immobilisation. A limited amount of research to date has generally supported this proposition. We hypothesise that, in comparison with the McCoy, the Airtraq laryngoscope will be associated with faster intubations of reduced complexity.

We intend to test our hypothesis by conducting a randomised, single-blind, controlled clinical trial. All patients will receive a standardised general anaesthetic with routine non-invasive monitoring. The neck will be immobilised using MILNS applied by an experienced assistant. Participants will be randomly assigned to tracheal intubation with either the Airtraq or the McCoy laryngoscope. All intubations will be performed by one of two consultant anaesthetists experienced in the use of both laryngoscopes. The primary outcome measures will be intubation time and the Intubation Difficulty Scale score. Any complications or difficulties will be recorded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28348 0
Dr Michael Bishop
Address 28348 0
Department of Anaesthesia and Perioperative Medicine, Royal Brisbane and Women's Hospital, Butterfield Street, Herston QLD 4029
Country 28348 0
Australia
Phone 28348 0
+61736468111
Fax 28348 0
Email 28348 0
michael.bishop2@health.qld.gov.au
Contact person for public queries
Name 11505 0
Dr Keith Greenland
Address 11505 0
Wesley Anaesthesia and Pain Management Group, Wesley Medical Centre, 40 Chasely Street, Auchenflower QLD 4066
Country 11505 0
Australia
Phone 11505 0
+61733770500
Fax 11505 0
+61738703139
Email 11505 0
french9a@yahoo.co.uk
Contact person for scientific queries
Name 2433 0
Dr Michael Bishop
Address 2433 0
Department of Anaesthesia and Perioperative Medicine, Royal Brisbane and Women's Hospital, Butterfield Street, Herston QLD 4029
Country 2433 0
Australia
Phone 2433 0
+61736468111
Fax 2433 0
+61736461308
Email 2433 0
michael.bishop2@health.qld.gov.au

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No Supporting Document Provided



Results publications and other study-related documents

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