Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000832279
Ethics application status
Approved
Date submitted
21/09/2009
Date registered
23/09/2009
Date last updated
29/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Video assisted laryngoscopy with cricoid pressure in patients using a C-Mac.
Scientific title
Blinded off line assessment of the effects of cricoid pressure with video assisted laryngoscopy in patients using a C-Mac,
Secondary ID [1] 283993 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
quality of the larygoscopic view with a video assisted laryngoscope during application of cricoid pressure 243891 0
Condition category
Condition code
Anaesthesiology 252066 252066 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 1: laryngoscopy without cricoid pressure; 5 seconds
Phase 2: with cricoid pressure without video assist; 5 seconds and
Phase 3: with cricoid pressure with video assist.10 seconds
Intervention code [1] 241321 0
Treatment: Devices
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 252961 0
comparison of laryngoscopic view with application of cricoid pressure assisted by video scope with cricoid applied without video assistance of person applying cricoid pressure. This is to be done using the Cormack and Lahane grading system that is in common use throughout the anaesthetic community
Timepoint [1] 252961 0
at time of intubation
Secondary outcome [1] 257699 0
comparison of quality of laryngoscopic view when cricoid is applied compared to prior to application. This is to be done using the Cormack and Lahane grading system that is in common use throughout the anaesthetic community
Timepoint [1] 257699 0
at time of intubation

Eligibility
Key inclusion criteria
patient requiring elective intubation for surgery
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
requiring rapid sequence induction, unable to give consent, unable to communicate in english.

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)
all aptients who accept enrollment will have the three phases of laryngoscopy without cricoid pressure, with cricoid pressure without video assist and then with video assist.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2009
Actual
1/02/2010
Date of last participant enrolment
Anticipated
1/09/2010
Actual
1/09/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243770 0
Hospital
Name [1] 243770 0
Peninsula Health
Country [1] 243770 0
Australia
Primary sponsor type
Hospital
Name
Peninsula Health
Address
Hastings Rd frankston 3199 Victoria
Country
Australia
Secondary sponsor category [1] 237129 0
None
Name [1] 237129 0
Address [1] 237129 0
Country [1] 237129 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243900 0
Peninsula Health
Ethics committee address [1] 243900 0
Ethics committee country [1] 243900 0
Australia
Date submitted for ethics approval [1] 243900 0
01/10/2009
Approval date [1] 243900 0
Ethics approval number [1] 243900 0

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

Contacts
Principal investigator
Name 30313 0
A/Prof Terence Edward Loughnan
Address 30313 0
Department of Anaesthesia, Frankston Hospital, Victoria , Australia 3199
Country 30313 0
Australia
Phone 30313 0
+61397847445
Fax 30313 0
+6187847441
Email 30313 0
[email protected]
Contact person for public queries
Name 13560 0
Terry Loughnan
Address 13560 0
Dept Anaesthesia
Peninsula Health
Frankston hospital
Hastings Rd
Frankston 3199 Victoria
Country 13560 0
Australia
Phone 13560 0
+61 3 97847445
Fax 13560 0
+61 3 97847441
Email 13560 0
[email protected]
Contact person for scientific queries
Name 4488 0
Terry Loughnan
Address 4488 0
Dept Anaesthesia
Peninsula Health
Frankston hospital
Frankston 3199 Victoria
Country 4488 0
Australia
Phone 4488 0
+61 3 97847445
Fax 4488 0
+61 3 97847441
Email 4488 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.