Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000710628
Ethics application status
Approved
Date submitted
2/11/2005
Date registered
4/11/2005
Date last updated
4/11/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of forces applied during direct laryngoscopy of medical simulators by operators of differing levels of experience using a modified laryngoscope.
Scientific title
Evaluation of forces applied during direct laryngoscopy of medical simulators by operators of differing levels of experience using a modified laryngoscope.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The force applied to the larynx through a laryngoscope during laryngoscopy 860 0
Condition category
Condition code
Other 927 927 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Forces applied during laryngoscopy will be measured by a modified laryngoscope designed by one of the investigators- not commercially available. Participants will perform laryngoscopy on the simulator centre manikins under standard conditions and under different degrees of difficulty, (tongue swelling, tongue swelling with cervical stabilization). 3 laryngoscopies will occur for each setting. The force will be measured for each. Participants will have varying experience of intubation.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 1212 0
To evaluate variability in force of laryngoscopy :
1. between operators under standard conditions and difficult conditions.
Timepoint [1] 1212 0
Primary outcome [2] 1213 0
To evaluate variability in force of laryngoscopy :
2. for the same operator for repeated measurements.
Timepoint [2] 1213 0
Primary outcome [3] 1214 0
To evaluate variability in force of laryngoscopy :
3. for the same operator under varying degrees of difficulty.
Timepoint [3] 1214 0
Primary outcome [4] 1215 0
To evaluate variability in force of laryngoscopy :
4. between operators of differing experience.
Timepoint [4] 1215 0

Eligibility
Key inclusion criteria
Medical students, Medical staff intubating less than 25 times a year, Non-anaesthetists who intubate 50 times or more a year, Anaesthetic trainees with less than 3 years experience, Qualified anaesthetists.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
65
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1021 0
Self funded/Unfunded
Name [1] 1021 0
Country [1] 1021 0
Primary sponsor type
Individual
Name
Dr. Mary Pinder
Address
Country
Secondary sponsor category [1] 885 0
Individual
Name [1] 885 0
Dr. Stuart Baker
Address [1] 885 0
Country [1] 885 0
Secondary sponsor category [2] 886 0
Individual
Name [2] 886 0
Dr Paul Sice
Address [2] 886 0
Country [2] 886 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2328 0
Sir Charles Gairdner Hospital
Ethics committee address [1] 2328 0
Ethics committee country [1] 2328 0
Australia
Date submitted for ethics approval [1] 2328 0
Approval date [1] 2328 0
Ethics approval number [1] 2328 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36107 0
Address 36107 0
Country 36107 0
Phone 36107 0
Fax 36107 0
Email 36107 0
Contact person for public queries
Name 9937 0
Dr. Mary Pinder
Address 9937 0
Centre for Anaesthesia Skills and Medical Simulation (CASMS)
Clinical Training and Education Centre (CTEC)
University of Western Australia
Mail Point M306
35 Stirling Highway
Crawley WA 6009
Country 9937 0
Australia
Phone 9937 0
+61 8 9346 4315
Fax 9937 0
Email 9937 0
mary.pinder@health.gov.au
Contact person for scientific queries
Name 865 0
Dr. Mary Pinder
Address 865 0
Centre for Anaesthesia Skills and Medical Simulation (CASMS)
Clinical Training and Education Centre (CTEC)
University of Western Australia
Mail Point M306
35 Stirling Highway
Crawley WA 6009
Country 865 0
Australia
Phone 865 0
+61 8 9346 4315
Fax 865 0
Email 865 0
mary.pinder@health.gov.au

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.