Trial Review

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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
Scientific title
Comparison of Video Laryngoscope vs. Direct Laryngoscope: Effects on Reducing Postoperative Sore Throat in Adults undergoing Single Lumen Intubation - a pilot study
Secondary ID [1] 312341 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesia 334111 0
Intubation 334112 0
Condition category
Condition code
Anaesthesiology 330783 330783 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 328828 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 338543 0
Postoperative sore throat
Timepoint [1] 338543 0
2 hours postoperatively
Secondary outcome [1] 436377 0
Sore throat
Timepoint [1] 436377 0
24 hours, 48 hours postoperatively
Secondary outcome [2] 436378 0
Quality of recovery
Timepoint [2] 436378 0
24 hours, 48 hours postoperatively
Secondary outcome [3] 436590 0
Feasibility
Timepoint [3] 436590 0
feasibility assessed 6 months after commencement of study
Secondary outcome [4] 436864 0
acceptability
Timepoint [4] 436864 0
within 4 hours of surgery

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26676 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 42717 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 316738 0
Hospital
Name [1] 316738 0
Departments of Anaesthesia - Westmead Hospital
Country [1] 316738 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health Disctrict
Address
Country
Australia
Secondary sponsor category [1] 318948 0
None
Name [1] 318948 0
Address [1] 318948 0
Country [1] 318948 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315512 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315512 0
https://www.wslhd.health.nsw.gov.au/Education-Portal/Research/ethics-governance
Ethics committee country [1] 315512 0
Australia
Date submitted for ethics approval [1] 315512 0
13/06/2024
Approval date [1] 315512 0
Ethics approval number [1] 315512 0

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134934 0
A/Prof Stefan Dieleman
Address 134934 0
Westmead Hospital, Department of Anaesthesia and perioperative medicine, Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Country 134934 0
Australia
Phone 134934 0
+61 288906447
Fax 134934 0
Email 134934 0
jan.dieleman@health.nsw.gov.au
Contact person for public queries
Name 134935 0
Stefan Dieleman
Address 134935 0
Westmead Hospital, Department of Anaesthesia and perioperative medicine, Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Country 134935 0
Australia
Phone 134935 0
+61 288906447
Fax 134935 0
Email 134935 0
jan.dieleman@health.nsw.gov.au
Contact person for scientific queries
Name 134936 0
Stefan Dieleman
Address 134936 0
Westmead Hospital, Department of Anaesthesia and perioperative medicine, Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Country 134936 0
Australia
Phone 134936 0
+61 288906447
Fax 134936 0
Email 134936 0
jan.dieleman@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Pilot study only


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.