Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000842965
Ethics application status
Approved
Date submitted
5/08/2011
Date registered
10/08/2011
Date last updated
15/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A novel modification of the Glidoscope to facilitate tracheal intubation in adult patient undergoing elective surgery under general anesthesia.
Scientific title
A novel modification of the Glidoscope to facilitate tracheal intubation in adult patient undergoing elective surgery under general anesthesia.
Secondary ID [1] 262793 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tracheal intubation time in seconds 270499 0
Condition category
Condition code
Anaesthesiology 270659 270659 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The use of a modification of the glidoscope in which a side channel is created to be a conduit for the passage of endotracheal tube parallel to the blade of the glidoscope into the glottic opening (down to trachea) under direct vision. Usual intubation time is 20-120 seconds. The trachea is intubated once at the induction of general anesthesia.
Intervention code [1] 269139 0
Other interventions
Intervention code [2] 269151 0
Treatment: Devices
Comparator / control treatment
In the classical glidoscope, the angle of the glidoscope's blade is 60 degrees angle which necessitate the use of intubating stylet to facilitate introduction of the endotracheal tube tip into the glottic opening and trachea within one to two minutes. This design of glidoscope creates some difficulty during tracheal intubation. In our modification we created a working channel on the side of the blade to facilitate the passage of endotracheal tube.
Control group
Active

Outcomes
Primary outcome [1] 269378 0
Intubation time in seconds
Timepoint [1] 269378 0
At the end of tracheal intubation
Secondary outcome [1] 287512 0
ease of intubation will be assessed at the end of endotracheal intubation by asking the anesthesiologist to indicate the level of easiness using a scale from 0 (the easiest intubation) to 10 (most difficult intubation)
Timepoint [1] 287512 0
at the end of tracheal intuabtion
Secondary outcome [2] 287513 0
view of glottic opening will be assessed at the end of tracheal intubation by asking the anesthesiologist to give his feedback regarding the visualization of the glottic opening using the Lehane and Cromack classification (well known to anesthesiologists)
Timepoint [2] 287513 0
at the end of tracheal intubation
Secondary outcome [3] 287514 0
Number of intubation attempt
Timepoint [3] 287514 0
at the end of tracheal intubation
Secondary outcome [4] 287515 0
number of failed intubation
Timepoint [4] 287515 0
at the end of tracheal intubation

Eligibility
Key inclusion criteria
Adult patients schedule for elective surgery under general anesthesia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients' refusal.
History of difficult intubation or any sign or symptom of difficult intubation.
Need for rapid sequence intubation.
Any contraindication for the use of glidoscope

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)
numbered opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
combutor generated randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3772 0
Saudi Arabia
State/province [1] 3772 0

Funding & Sponsors
Funding source category [1] 269615 0
University
Name [1] 269615 0
Department of anesthesia & critical care, faculty of medicine, King abdulaziz University
Country [1] 269615 0
Saudi Arabia
Primary sponsor type
University
Name
department of anesthesia & critical care, faculty of medicine, King abdulaziz University
Address
King Abdulaziz University
P.O. Box 80215
Jeddah 21589
Country
Saudi Arabia
Secondary sponsor category [1] 266647 0
None
Name [1] 266647 0
Address [1] 266647 0
Country [1] 266647 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269563 0
Research and Ethics Committee
Ethics committee address [1] 269563 0
Department of anesthesia and critical care, faculty of medicine, King Abdulaziz University
P.O. Box 80215
Jeddah 21589
Ethics committee country [1] 269563 0
Saudi Arabia
Date submitted for ethics approval [1] 269563 0
Approval date [1] 269563 0
05/07/2011
Ethics approval number [1] 269563 0
ANE 16-11

Summary
Brief summary
To use a modification of the glidoscope in which a side channel is created to be a conduit for the passage of endotracheal tube parallel to the blade into the glottic opening under direct vision and to compare that to the classical glidoscope (no working channel) regarding the intubation time, ease of intubation, glottic view, number of intubation attempts and number of failed attempts
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32986 0
Address 32986 0
Country 32986 0
Phone 32986 0
Fax 32986 0
Email 32986 0
Contact person for public queries
Name 16233 0
Dr Abdullah M. Kaki
Address 16233 0
department of anesthesia & critical care, faculty of medicine, King Abdulaziz University
P.O. Box 80215
Jeddah 21589
Country 16233 0
Saudi Arabia
Phone 16233 0
+966-2-6408335
Fax 16233 0
+966-2-6408335
Email 16233 0
[email protected]
Contact person for scientific queries
Name 7161 0
Dr Abdullah M. Kaki
Address 7161 0
department of anesthesia & critical care, faculty of medicine, King Abdulaziz University
P.O. Box 80215
Jeddah 21589
Country 7161 0
Saudi Arabia
Phone 7161 0
+966-2-6408335
Fax 7161 0
+ 966-2-6408335
Email 7161 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
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