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Trial registered on ANZCTR


Registration number
ACTRN12611000310965
Ethics application status
Approved
Date submitted
17/03/2011
Date registered
24/03/2011
Date last updated
10/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Known difficult intubation: A randomised, prospective comparison of direct and videolaryngoscopy.
Scientific title
Known difficult intubation: A randomised, prospective comparison of conventional intubation (Macintosh blade) or videolaryngoscope (A.P. Advance) to determine time to successful intubation, glottic view, ease of use and complications in patients with known difficult intubation.
Secondary ID [1] 259812 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Difficult Intubation 261393 0
Condition category
Condition code
Anaesthesiology 265548 265548 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomised to receive either a conventional Macintosh blade or an A.P. Advance(trademark) videoscope using the Difficult Airway Blade.
The intervention (intubation using either the standard macintosh laryngoscope or the AP advance) will be a single event utilising standard intubating techniques (induction of anaesthesia and muscle relaxation) at the start of planned surgery requiring intubation. The sole difference between the groups will be the type of laryngoscope used.
Duration of intervention will be less than 15 minutes
Intervention code [1] 264242 0
Treatment: Devices
Comparator / control treatment
Standard Macintosh Laryngoscope
Control group
Active

Outcomes
Primary outcome [1] 262356 0
Time to intubation
Timepoint [1] 262356 0
at intervention
Secondary outcome [1] 273619 0
Number of attempts at layngoscopy
Timepoint [1] 273619 0
at intervention
Secondary outcome [2] 273620 0
Visual Analogue score of ease of use
Timepoint [2] 273620 0
immediately following intervention
Secondary outcome [3] 273621 0
View of glottic opening (Cormack and Lehane 1-4 with Macintosh blade) or 'Video-assited view' (full, partial, none)
Timepoint [3] 273621 0
at intervention

Eligibility
Key inclusion criteria
Previous Cormack and Lehane grade 3 or 4 view at intubation.
Anticipated easy ventilation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Anticipated need for Awake fiberoptic intubation by treating anaesthetist
Critical illness
Requirement for rapid sequence 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)
Patients planned for intubation to facilitate their surgery will have previous anaesthetic records scanned for documentation regarding past Laryngoscopic view.
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 based on a predetermined, randomly generated treatment allocation list.
This list will be held in a secure location and the allocation assigned will be told to the treating doctors by a member of staff not directly involved in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
binary random number generation
Masking / blinding
Open (masking not 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
Recruiting
Date of first participant enrolment
Anticipated
18/04/2011
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)

Funding & Sponsors
Funding source category [1] 264693 0
Hospital
Name [1] 264693 0
Fremantle Hospital
Country [1] 264693 0
Australia
Funding source category [2] 264694 0
Commercial sector/Industry
Name [2] 264694 0
Venner SA, A Venner Group Company
Country [2] 264694 0
Australia
Primary sponsor type
Hospital
Name
Fremanlte Hospital
Address
Alma St,
Fremantle
WA
6160
Country
Australia
Secondary sponsor category [1] 263826 0
None
Name [1] 263826 0
Address [1] 263826 0
Country [1] 263826 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266685 0
Ethics committee address [1] 266685 0
Ethics committee country [1] 266685 0
Date submitted for ethics approval [1] 266685 0
08/03/2011
Approval date [1] 266685 0
Ethics approval number [1] 266685 0

Summary
Brief summary
The trial looks to establish if the use of a videolaryngoscope in patients with a known difficult airway makes intubation easier, faster and safer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32358 0
Address 32358 0
Country 32358 0
Phone 32358 0
Fax 32358 0
Email 32358 0
Contact person for public queries
Name 15605 0
Dr Alex Swann
Address 15605 0
Department of Anaesthesia
Fremantle Hospital
Alma St,
Fremantle
WA
6160
Country 15605 0
Australia
Phone 15605 0
+61 8 9431 3333
Fax 15605 0
Email 15605 0
[email protected]
Contact person for scientific queries
Name 6533 0
Dr Alex Swann
Address 6533 0
Department of Anaesthesia
Fremantle Hospital
Alma St,
Fremantle
WA
6160
Country 6533 0
Australia
Phone 6533 0
+61 8 9431 3333
Fax 6533 0
Email 6533 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.