Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000737932
Ethics application status
Approved
Date submitted
13/07/2011
Date registered
14/07/2011
Date last updated
22/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
SensaScope (Registered Trademark) vs. Retromolar scope for Tracheal Intubation
Scientific title
SensaScope (Registered Trademark) vs. Retromolar scope for Tracheal Intubation
Secondary ID [1] 262623 0
Nil
Universal Trial Number (UTN)
U1111-1122-7031
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tracheal intubation 268320 0
Condition category
Condition code
Anaesthesiology 268450 268450 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: tracheal intubation using the SensaScope.
Arm 2: tracheal intubation suing the Bonfils retromolar scope.
After anesthesia induction, the anesthesiologist will use either the SensaScope or Bonfils Retromolar scope (based on randomization) to intubate the patient under direct vision. Tracheal intubation should be achieved within one minute. If not, the procedure is aborted and the patient is manually ventilated for 15 seconds, then a second attempt is made with the same device. After 3 unsuccessful attempts at intubation, the patient will be deemed difficult to intubate and the standard algorithm for difficult intubation will be followed.
Intervention code [1] 266971 0
Treatment: Devices
Comparator / control treatment
Arm 3: tracheal intubation using a conventional laryngoscope.
After anesthesia induction, the anesthesiologist will use the conventional laryngoscope (based on randomization) to intubate the patient under direct vision. Tracheal intubation should be achieved within one minute. If not, the procedure is aborted and the patient is manually ventilated for 15 seconds, then a second attempt is made with the same device. After 3 unsuccessful attempts at intubation, the patient will be deemed difficult to intubate and the standard algorithm for difficult intubation will be followed.
Control group
Active

Outcomes
Primary outcome [1] 269207 0
Time to successful tracheal intubation will be measured using a stop watch. The start time is when the airway device is inserted into the oral cavity and the finish time is when the airway device is removed from the oral cavity
Timepoint [1] 269207 0
at the end of successful tracheal intubation, the total time required for intubation will be recoreded.
Primary outcome [2] 269208 0
Cardiac output changes in response to tracheal intubation will measured non-invasively using the Nexfin (Registered Trademark) monitor which will be applied prior to inductino of anesthesia.
Timepoint [2] 269208 0
At Baseline, on induction of anesthesia and every minute thereafter until 3 minutes after successful tracheal intubation
Primary outcome [3] 269209 0
Hemodynamic response to tracheal intubation will be determined by measuring systolic, diastolic, and mean blood pressure together with heart rate using the Nexfin (Registered Trademark) monitor.
Timepoint [3] 269209 0
At Baseline, on induction of anesthesia and every minute thereafter until 3 minutes after successful tracheal intubation
Secondary outcome [1] 279125 0
Number of attempts at tracheal intubation
Timepoint [1] 279125 0
at the end of successful tracheal intubation

Eligibility
Key inclusion criteria
- ASA 1 or 2 patients
- Elective surgery that requires tracheal intubation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Hypertension
- Ischemic heart disease
- Diabetes mellitus
- Chronic opioid use
- Aspiration risk
- Anticipated difficult intubation

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomization schedule
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
16/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment outside Australia
Country [1] 3708 0
Saudi Arabia
State/province [1] 3708 0

Funding & Sponsors
Funding source category [1] 267436 0
Self funded/Unfunded
Name [1] 267436 0
Department of Anesthesia and Critical Care
Country [1] 267436 0
Saudi Arabia
Primary sponsor type
University
Name
King Abdulaziz University
Address
P.O. Box 80215
Jeddah 21589
Country
Saudi Arabia
Secondary sponsor category [1] 266484 0
None
Name [1] 266484 0
Address [1] 266484 0
Country [1] 266484 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269411 0
Research and Ethics Committee
Ethics committee address [1] 269411 0
Department of Anesthesia and Critical Care
King Abdulaziz University Hospital
P.O. Box 80215
Jeddah 21589
Ethics committee country [1] 269411 0
Saudi Arabia
Date submitted for ethics approval [1] 269411 0
Approval date [1] 269411 0
08/06/2011
Ethics approval number [1] 269411 0
ANE15-11

Summary
Brief summary
This study is designed to determine the stress response to tracheal intubation using a non-invasive device that measures blood flow from the heart, blood pressure, and heart rate. In addition, it will determine the time required for tracheal intubation using two special airway devices and compare it with the time required using a conventional airway device. These special devices are used for difficult intubation cases but we will use them in patients with expected easy intubation in this study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32872 0
Address 32872 0
Country 32872 0
Phone 32872 0
Fax 32872 0
Email 32872 0
Contact person for public queries
Name 16119 0
Prof. Jamal A. Alhashemi
Address 16119 0
Department of Anesthesia and Critical Care
King Abdulaziz University Hospital
P.O. Box 80215
Jeddah 21589
Country 16119 0
Saudi Arabia
Phone 16119 0
966-2-6408335
Fax 16119 0
Email 16119 0
[email protected]
Contact person for scientific queries
Name 7047 0
Prof. Jamal A. Alhashemi
Address 7047 0
Department of Anesthesia and Critical Care
King Abdulaziz University Hospital
P.O. Box 80215
Jeddah 21589
Country 7047 0
Saudi Arabia
Phone 7047 0
966-2-6408335
Fax 7047 0
Email 7047 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.