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
ACTRN12613000313730
Ethics application status
Approved
Date submitted
19/03/2013
Date registered
20/03/2013
Date last updated
15/04/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Self controlled trial of Ambu Ascope for training clinicians in fibreoptic device guided intubation
Scientific title
An evaluation of the Ambu Ascope for training clinicians in fibreoptic device guided orotracheal intubation as assessed using a Global Rating Scale
Secondary ID [1] 282117 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Airway management 288610 0
Condition category
Condition code
Anaesthesiology 288943 288943 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ascope assisted orotracheal intubations will be performed on anaesthetised patients
Operators given set of 5 Ascopes - operators are composed of 5 consultant anaesthetists and 3 anaesthesia registrars
1st to 5th attempt will be recorded on notebook PC. All attempts are carried out on different patients.
Ascope will be used for each attempt
GRS score evaluated on recordings
Intervention code [1] 286720 0
Treatment: Devices
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289071 0
GRS score - Global Rating Scale - score of 1-5 to define bronchoscopic efficacy
Timepoint [1] 289071 0
during performance of Ascope assisted intubation
Secondary outcome [1] 301675 0
intubation success
Timepoint [1] 301675 0
during performance of Ascope assisted intubation
Secondary outcome [2] 301857 0
intubation time
Timepoint [2] 301857 0
during performance of Ascope assisted intubation

Eligibility
Key inclusion criteria
able to consent for themselves
general anaesthesia
orotracheal intubation
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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2013
Actual
12/03/2013
Date of last participant enrolment
Anticipated
Actual
21/11/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 735 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 6534 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 286882 0
Hospital
Name [1] 286882 0
The Northern Hospital
Country [1] 286882 0
Australia
Funding source category [2] 286883 0
Commercial sector/Industry
Name [2] 286883 0
Ambu Australia
Country [2] 286883 0
Australia
Primary sponsor type
Hospital
Name
The Northern Hospital
Address
185 Cooper St
Epping
Victoria 3076
Country
Australia
Secondary sponsor category [1] 285673 0
None
Name [1] 285673 0
Address [1] 285673 0
Country [1] 285673 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288975 0
Northern Health HREC
Ethics committee address [1] 288975 0
Northern Hospital
185 Cooper St
Epping
Vic 3076
Ethics committee country [1] 288975 0
Australia
Date submitted for ethics approval [1] 288975 0
Approval date [1] 288975 0
27/11/2012
Ethics approval number [1] 288975 0
P17/12

Summary
Brief summary
This research is designed specifically to compare the performance before and after exposure to the Ambu Ascope in the clinical setting for scope guided intubation.
Endpoints will be GRS score, success in intubation and time taken for intubation on the first and 5th attempts with Ascope.
The null hypothesis for this research project is that there is no difference in GRS score before and after 5 attempts with Ambu Ascope
Trial website
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 38454 0
Dr Jun Keat Chan
Address 38454 0
Department of Anaesthesia and Pain Management
Northern Hospital
185 Cooper St
Epping
Vic 3076
Country 38454 0
Australia
Phone 38454 0
+61384058000
Fax 38454 0
Email 38454 0
[email protected]
Contact person for public queries
Name 38455 0
Dr Jun Keat Chan
Address 38455 0
Department of Anaesthesia and Pain Management
Northern Hospital
185 Cooper St
Epping
Vic 3076
Country 38455 0
Australia
Phone 38455 0
+61384058000
Fax 38455 0
Email 38455 0
[email protected]
Contact person for scientific queries
Name 38456 0
Dr Jun Keat Chan
Address 38456 0
Department of Anaesthesia and Pain Management
Northern Hospital
185 Cooper St
Epping
Vic 3076
Country 38456 0
Australia
Phone 38456 0
+61384058000
Fax 38456 0
Email 38456 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.