Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001235998
Ethics application status
Approved
Date submitted
29/11/2011
Date registered
2/12/2011
Date last updated
14/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial comparing the Ambu Ascope with conventional fibreoptic bronchoscope in asleep orotracheal intubation of adult patients undergoing general anaesthesia
Scientific title
Randomised controlled trial comparing the Ambu Ascope with conventional fibreoptic bronchoscope in asleep orotracheal intubation of adult patients undergoing general anaesthesia
Secondary ID [1] 273484 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Comparing airway equipment in asleep fibreoptic intubation 279274 0
Condition category
Condition code
Anaesthesiology 279472 279472 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 – fibreoptic guided orotracheal intubation in anaesthetised patient with Ambu Ascope
- intervention post induction of anaesthesia
- intervention to be performed until endotracheal tube in place or until operator decides to stop
- intervention to be performed once only on the participant
- each participant to receive only one intervention - either Ambu Ascope or Karl Storz intubating bronchoscope
- intervention will only take place during a single episode of anaesthesia - average duration will be 3 minutes
Intervention code [1] 283802 0
Treatment: Devices
Comparator / control treatment
standard intubating fibreoptic bronchoscope - Karl Storz
- intervention post induction of anaesthesia
- intervention to be performed until endotracheal tube in place or until operator decides to stop
- intervention to be performed once only on the participant
- each participant to receive only one intervention - either Ambu Ascope or Karl Storz intubating bronchoscope
- intervention will only take place during a single episode of anaesthesia - average duration will be 3 minutes
Control group
Active

Outcomes
Primary outcome [1] 286040 0
Global Rating Scale (scale used to rank efficacy of fibreoptic skills)
Timepoint [1] 286040 0
post randomisation, recruitment and completion of recording of fibreoptic intubation
Secondary outcome [1] 295028 0
Success of intubation
- verification of placement of endotracheal tube both visually and by capnography
Timepoint [1] 295028 0
post randomisation, recruitment and completion of recording of fibreoptic intubation
Secondary outcome [2] 295029 0
Time to intubation
- time from commencement of fibreoptic bronchoscopy to verification of endotracheal tube placement
- using video recording and stopwatch
Timepoint [2] 295029 0
post randomisation, recruitment and completion of recording of fibreoptic intubation

Eligibility
Key inclusion criteria
able to consent for themselves, general anaesthesia,orotracheal intubation, adults, ASA I-III, fasted for surgery
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with indication for awake FOI, inhalational induction, known difficult/ impossible mask ventilation, rapid sequence induction

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)
Envelope containing allocation of device to participant
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block randomisation
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
Completed
Date of first participant enrolment
Anticipated
1/12/2011
Actual
2/02/2012
Date of last participant enrolment
Anticipated
Actual
2/11/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284276 0
Hospital
Name [1] 284276 0
Department of Anaesthesia and Pain Management, Royal Melbourne Hospital
Country [1] 284276 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia and Pain Management, Royal Melbourne Hospital
Address
Grattan Street
Parkville
Victoria 3052
Country
Australia
Secondary sponsor category [1] 283232 0
Commercial sector/Industry
Name [1] 283232 0
Ambu A/S
Address [1] 283232 0
Baltorpbakken 13
DK-2750 Ballerup
Denmark
Country [1] 283232 0
Denmark

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286240 0
Melbourne HREC
Ethics committee address [1] 286240 0
Royal Melbourne Hospital
Grattan Street
Parkville
Victoria 3052
Ethics committee country [1] 286240 0
Australia
Date submitted for ethics approval [1] 286240 0
Approval date [1] 286240 0
08/08/2011
Ethics approval number [1] 286240 0
2011.079

Summary
Brief summary
This research is designed to specifically compare the performance of the bronchoscopes in the clinical setting using a validated rating scale for bronchoscopic performance – the Global Rating Scale
Trial website
Trial related presentations / publications
awaiting publication in Anaesthesia and Intensive Care
Public notes

Contacts
Principal investigator
Name 33452 0
Dr Jun Keat Chan
Address 33452 0
Northern Health
185 Cooper Street
Epping
Victoria 3076
Country 33452 0
Australia
Phone 33452 0
+61384058000
Fax 33452 0
Email 33452 0
[email protected]
Contact person for public queries
Name 16699 0
Dr Dr Jun Keat Chan
Address 16699 0
PO Box 1466
Epping
Victoria 3076
Country 16699 0
Australia
Phone 16699 0
+61384058000
Fax 16699 0
Email 16699 0
[email protected]
Contact person for scientific queries
Name 7627 0
Dr Dr Jun Keat Chan
Address 7627 0
PO Box 1466
Epping
Victoria 3076
Country 7627 0
Australia
Phone 7627 0
+61384058000
Fax 7627 0
Email 7627 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.