Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000101381
Ethics application status
Not yet submitted
Date submitted
19/02/2008
Date registered
22/02/2008
Date last updated
20/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of Airway Scope and GlideScope in patients with Cervical Spine Immobilisation
Scientific title
Comparison of Airway Scope and GlideScope with respect to intubation time and intubation difficulty scale (IDS) scores in patients with cervical spine immobilisation
Secondary ID [1] 287953 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Spine immobilisation 2849 0
Condition category
Condition code
Anaesthesiology 2982 2982 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single tracheal intubation using the Airway Scope. The process involves placing a breathing tube in the trachea 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 patients mouth. The Airway Scope is a novel video laryngoscope with a number of design features that suggest its utility in the setting of cervical spine immobilisation.
Intervention code [1] 2579 0
Treatment: Devices
Comparator / control treatment
A single tracheal intubation using the GlideScope. The process involves placing a breathing tube in the trachea 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 patients mouth. The GlideScope is a video laryngoscope with an established place in the airway management of patients with cervical spine immobilisation.
Control group
Active

Outcomes
Primary outcome [1] 3860 0
Time of intubation
Timepoint [1] 3860 0
At intubation
Primary outcome [2] 3861 0
Intubation Difficulty Scale (IDS) Score
Timepoint [2] 3861 0
At intubation
Secondary outcome [1] 6500 0
Rate of successful placement of the tracheal tube
Timepoint [1] 6500 0
At intubation
Secondary outcome [2] 6501 0
Cormack & Lehane grade
Timepoint [2] 6501 0
At laryngoscopy
Secondary outcome [3] 6502 0
Number of intubation attempts
Timepoint [3] 6502 0
At laryngoscopy
Secondary outcome [4] 6503 0
Number of optimisation manoeuvres required to aid tracheal intubation
Timepoint [4] 6503 0
At intubation

Eligibility
Key inclusion criteria
Patients presenting for elective surgery requiring tracheal intubation Americian Society Anesthesiologists (ASA) physical status 1-3
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Age >18, Mental impairment, Clinical signs of difficult airway, History of difficult airway

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 by using a randomisation table from a statistic book.
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
1/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 779 0
4006

Funding & Sponsors
Funding source category [1] 3100 0
Hospital
Name [1] 3100 0
Royal Brisbane and Women's Hospital
Country [1] 3100 0
Australia
Primary sponsor type
Individual
Name
Michael Edwards
Address
Department of Anaesthesia & Perioperative Medicine
Royal Brisbane and Women's Hospital
Butterfield Street
Herston Queensland 4006
Country
Australia
Secondary sponsor category [1] 2792 0
None
Name [1] 2792 0
Address [1] 2792 0
Country [1] 2792 0
Other collaborator category [1] 207 0
Individual
Name [1] 207 0
James Troup
Address [1] 207 0
Department of Anaesthesia & Perioperative Medicine
Royal Brisbane and Women's Hospital
Butterfield Street
Herston Queensland 4006
Country [1] 207 0
Australia
Other collaborator category [2] 208 0
Individual
Name [2] 208 0
Keith Greenland
Address [2] 208 0
Department of Anaesthesia & Perioperative Medicine
Royal Brisbane and Women's Hospital
Butterfield Street
Herston Queensland 4006
Country [2] 208 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5080 0
Royal Brisbane and Women's Health Service District Human Research Ethics Committe
Ethics committee address [1] 5080 0
Level 7, Block 7 Royal Brisbane and Women's Hospital
Butterfield Street
Herston Queensland 4029
Ethics committee country [1] 5080 0
Australia
Date submitted for ethics approval [1] 5080 0
08/01/2008
Approval date [1] 5080 0
Ethics approval number [1] 5080 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 Airway Scope and GlideScope laryngoscopes for tracheal intubation in patients with cervical spine immobilisation using MILNS. The
GlideScope laryngoscope, is a modification of the standard Macintosh blade, with a high-resolution camera and with a light source for illumination embedded within the blade. Endotracheal intubation is performed based on an image on a screen. Its use is well described in the airway management of patients with immobilised cervical spines. The Airway Scope, in contrast, is a novel intubation device. It is a video laryngoscope with a reusable handle and desposible blade. 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 intend to 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 Airway Scope or the GlideScope. All intubations will be performed by one anaesthetist 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 28385 0
Dr Michael Edwards
Address 28385 0
As below
Country 28385 0
Australia
Phone 28385 0
as below
Fax 28385 0
Email 28385 0
as below
Contact person for public queries
Name 11542 0
Dr Dr Keith Greenland
Address 11542 0
Department of Anaesthesia & Perioperative Medicine
Royal Brisbane and Women's Hospital
Butterfield Street
Herston Queensland 4006
Country 11542 0
Australia
Phone 11542 0
(07) 36368111
Fax 11542 0
(07) 36361308
Email 11542 0
[email protected]
Contact person for scientific queries
Name 2470 0
Dr Dr Michael Edwards
Address 2470 0
Department of Anaesthesia & Perioperative Medicine
Royal Brisbane and Women's Hospital
Butterfield Street
Herston Queensland 4006
Country 2470 0
Australia
Phone 2470 0
(07) 36368111
Fax 2470 0
(07) 36361308
Email 2470 0
[email protected]

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
No additional documents have been identified.