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Trial registered on ANZCTR
Registration number
ACTRN12624000805572p
Ethics application status
Submitted, not yet approved
Date submitted
14/06/2024
Date registered
29/06/2024
Date last updated
29/06/2024
Date data sharing statement initially provided
29/06/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Video Laryngoscope versus Direct Laryngoscope and postoperative sore throat
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Scientific title
Comparison of Video Laryngoscope vs. Direct Laryngoscope: Effects on Reducing Postoperative Sore Throat in Adults undergoing Single Lumen Intubation - a pilot study
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Secondary ID [1]
312341
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anaesthesia
334111
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Intubation
334112
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Condition category
Condition code
Anaesthesiology
330783
330783
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0
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Anaesthetics
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Video laryngoscopy
-The video laryngoscope is a device used during the induction of anesthesia to assist with endotracheal intubation. It consists of a handle with a screen and a blade. During intubation, the video laryngoscope blade is inserted into the patient's mouth to visualize the glottis and vocal cords on the screen. This visualization helps guide the endotracheal tube into the trachea.
-It is typically a one-time process per intubation attempt. The procedure duration can vary but generally takes about 30 seconds to a minute.
-To make this study pragmatic and feasible, intubations can be performed by either a consultant anaesthetist or by trainees who are supervised by a consultant anaesthetist.
-Adherence to proper technique and use of video laryngoscope is monitored through procedural documentation.
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Intervention code [1]
328828
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Treatment: Other
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Comparator / control treatment
Direct laryngoscope
- The direct laryngoscope is a traditional device used during the induction of anesthesia for endotracheal intubation. It consists of a handle and a blade. Unlike the video laryngoscope, which relies on a camera and screen for visualization, the direct laryngoscope provides a direct line of sight.
-The direct laryngoscope procedure is typically a one-time process per intubation attempt and can take about 30 seconds to a minute.
-To make this study pragmatic and feasible, intubations can be performed by either a consultant anaesthetist or by trainees who are supervised by a consultant anaesthetist.
-Adherence to proper technique and use of video laryngoscope is monitored through procedural documentation.
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Control group
Active
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Outcomes
Primary outcome [1]
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Postoperative sore throat
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Assessment method [1]
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The questionnaire has been custom-designed for this study to gather postoperative sore throat.
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Timepoint [1]
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2 hours postoperatively
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Secondary outcome [1]
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Sore throat
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Assessment method [1]
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The questionnaire has been custom-designed for this study to gather postoperative sore throat.
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Timepoint [1]
436377
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24 hours, 48 hours postoperatively
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Secondary outcome [2]
436378
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Quality of recovery
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Assessment method [2]
436378
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QoR-15 questionnaire
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Timepoint [2]
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24 hours, 48 hours postoperatively
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Secondary outcome [3]
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Feasibility
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Assessment method [3]
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To assess feasibility : this will be assessed by evaluating recruitment rates determined from study records, adherence determined by audit hospital records, and completeness of data by reviewing completed questionnaire.
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Timepoint [3]
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feasibility assessed 6 months after commencement of study
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Secondary outcome [4]
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acceptability
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Assessment method [4]
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adherence to randomization collected by audit hospital record
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Timepoint [4]
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within 4 hours of surgery
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Eligibility
Key inclusion criteria
- Patient age 18 years old and over
- Participants who are scheduled to undergo single lumen intubation via the oral route.
- Operation less than 4 hours
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Anticipated difficult intubation
- Head and neck surgery
- Recent upper respiratory tract infection (URTI) in a week prior to the surgery
- Concurrent medication contains steroid or regular analgesics
- Planned nasogastric tube insertion both prior and after surgery
- Procedure where a throat pack is required
- Non-English speakers
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Continuous variables will be compared using independent Student’s
t-test or Mann–Whitney U-test. Categorical variables will be compared using Chi square or Fisher’s exact test. The primary outcomes, the relative risk with 95% CI will be calculated. A p value <0.05 is considered as statistically significant.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/09/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
42717
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2145 - Westmead
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Departments of Anaesthesia - Westmead Hospital
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Government body
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Name
Western Sydney Local Health Disctrict
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
318948
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Country [1]
318948
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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Western Sydney Local Health District Human Research Ethics Committee
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Ethics committee address [1]
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https://www.wslhd.health.nsw.gov.au/Education-Portal/Research/ethics-governance
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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13/06/2024
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Approval date [1]
315512
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Ethics approval number [1]
315512
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Summary
Brief summary
This is a pilot study assessing feasibility, acceptability of a larger study, as well as to estimate the incidence of postoperative sore throat.. These results will inform a larger study that has the aim to assess patient experience outcomes following elective intubation comparing between DL and VL
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Stefan Dieleman
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Address
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Westmead Hospital, Department of Anaesthesia and perioperative medicine, Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
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Country
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Australia
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Phone
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+61 288906447
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Stefan Dieleman
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Address
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Westmead Hospital, Department of Anaesthesia and perioperative medicine, Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
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Country
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Australia
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Phone
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+61 288906447
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Fax
134935
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Email
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[email protected]
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Contact person for scientific queries
Name
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Stefan Dieleman
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Address
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Westmead Hospital, Department of Anaesthesia and perioperative medicine, Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
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Country
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Australia
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Phone
134936
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+61 288906447
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Fax
134936
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Pilot study only
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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.
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