Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000930987
Ethics application status
Approved
Date submitted
30/06/2020
Date registered
18/09/2020
Date last updated
18/09/2020
Date data sharing statement initially provided
18/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the effects on blood oxygen level between two delivery of oxygen methods during short endoscopic procedures
Scientific title
High-flow mouthguard versus conventional oxygen therapy in preventing the loss of oxygenation for short, low-sedation-risk endoscopic procedures: a randomised single-blinded trial
Secondary ID [1] 301655 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oxygen desaturation during endoscopic procedures 318081 0
Airway management 318375 0
Condition category
Condition code
Anaesthesiology 316110 316110 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1:High-flow mouthguard (Oxyguard D® at 20L/min) as a method of oxygen delivery for low-risk for sedation patients undergoing elective short (up to 20 minutes) endoscopic procedures in an Australian tertiary hospital.
The high-flow mouthguard is a modified mouthguard which in addition to offer protection for the teeth also has an integrated oxygen delivery system. This will be used by the anaesthetist to deliver oxygen instead of the standard nasal prongs and will be used as per standard of practice. As per standard of practice, the device will be adapted to the mouth having the oxygen output facing the patient nostrils and secured around the neck prior to the sedation is commenced. As per standard of practice, supplementary oxygen is used throughout the whole endoscopic procedure and is maintained until the patient is fully recovered from sedation in the recovery room. The high flow will be maintained for the entire duration of the endoscopic procedure but can be brought down once the procedure has been finished and the patient sent to the recovery room, at the anaesthetist's discretion. The sedation and procedure data will be collected by one of the investigators or their delegates, in the room the endoscopic procedure is taking place.
Intervention code [1] 317964 0
Treatment: Devices
Intervention code [2] 317965 0
Prevention
Comparator / control treatment
Arm 2: Conventional oxygen therapy (standard nasal cannula at 2L/min) for low-risk for sedation patients undergoing elective short (up to 20 minutes) endoscopic procedures in an Australian tertiary hospital.
The standard nasal cannula will be used by the anaesthetist as per standard of practice. The sedation and procedure data will be collected by one of the investigators or their delegates, in the room the endoscopic procedure is taking place.
Control group
Active

Outcomes
Primary outcome [1] 324299 0
Comparison of moderate oxygen desaturation rates (<90%) between the two groups, assessed through a finger pulse oximeter.
Timepoint [1] 324299 0
Calculated per patient, summarised at the end of each endoscopy procedure by the anaesthetist and endoscopist.
Secondary outcome [1] 384277 0
Comparison of variable oxygen desaturation rates (e.g. 94%, 92%) between the two groups, assessed through a finger pulse oximeter.
Timepoint [1] 384277 0
Assessed per patient, summarised at the end of each endoscopy procedure by the anaesthetist and endoscopist.
Secondary outcome [2] 384955 0
Comparison of symptoms post-procedure, procedure- and sedation-related adverse events (e.g. dry mouth, headache).

Post procedure symptoms will be assessed through a visual analog scale questionnaire.

Procedure- and sedation-related adverse events (e.g. number of desaturation events, perforation, bleeding) will be assessed directly by the anaesthetist and endoscopist of the case and filled into a data collection sheet
Timepoint [2] 384955 0
Assessed per patient, post-procedure, before discharge.

The vast majority of elective endoscopic procedures are discharged on the same day of the procedure, after the patient recovers from the sedation. The exact time a patient recovers from the sedation though is variable. In addition, other factors such as pain and sedation- and procedure-related adverse events can lead a patient to stay for a longer period of time.

Within these limitations, the plans are to assess sedation- and procedure-related adverse events during the procedure and populate the datasheet within one hour after the procedure had been finalised. The assessment of symptoms post-procedure is expected to take place at least 30 minutes after the patient has been sent to the recovery room and once he/she is able to maintain his/her eyes open spontaneously. The symptoms’ questionnaire is planned to be given to the patient within 6 hours after the procedure has been finalised.

Eligibility
Key inclusion criteria
• Patients referred for upper gastrointestinal endoscopic procedures predicted to last less or equal to 20 minutes (e.g. diagnostic gastroscopies)
• Age > 18 years
• Ability to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pregnancy
• Supplementary O2 dependency
• Emergency procedures
• Deemed by performing endoscopist as long (>20 minutes) procedure before randomisation
• Patients with high risk for sedation (i.e. presence of any of the following criteria: BMI greater or equal to 35, ASA IV or Mallampati 4)
• Capsule endoscopy procedure

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/11/2020
Actual
Date of last participant enrolment
Anticipated
15/11/2021
Actual
Date of last data collection
Anticipated
15/11/2021
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17003 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 17004 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 30666 0
3084 - Heidelberg
Recruitment postcode(s) [2] 30667 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 306089 0
Hospital
Name [1] 306089 0
Austin Health
Country [1] 306089 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road, Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 306558 0
Individual
Name [1] 306558 0
Leonardo Zorron Cheng Tao Pu
Address [1] 306558 0
Austin Health
Gastroenterology Department
145 Studley Road, Heidelberg VIC 3084
Country [1] 306558 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306309 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 306309 0
Ethics committee country [1] 306309 0
Australia
Date submitted for ethics approval [1] 306309 0
Approval date [1] 306309 0
29/06/2020
Ethics approval number [1] 306309 0
HREC/63130/Austin-2020

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

Contacts
Principal investigator
Name 103454 0
Dr Leonardo Zorron Cheng Tao Pu
Address 103454 0
Austin Health
Gastroenterology Department
145 Studley Road, Heidelberg, VIC 3084
Country 103454 0
Australia
Phone 103454 0
+61 433 930 442
Fax 103454 0
Email 103454 0
[email protected]
Contact person for public queries
Name 103455 0
Leonardo Zorron Cheng Tao Pu
Address 103455 0
Austin Health
Gastroenterology Department
145 Studley Road, Heidelberg, VIC 3084
Country 103455 0
Australia
Phone 103455 0
+61 433 930 442
Fax 103455 0
Email 103455 0
[email protected]
Contact person for scientific queries
Name 103456 0
Leonardo Zorron Cheng Tao Pu
Address 103456 0
Austin Health
Gastroenterology Department
145 Studley Road, Heidelberg, VIC 3084
Country 103456 0
Australia
Phone 103456 0
+61 433 930 442
Fax 103456 0
Email 103456 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Only summarised/grouped and de-identified data will be publicly shared as per HREC submission. No IPD will be publicly shared. No raw data will be publicly available.

However, upon request by another research team, all of the individual participant data collected during the trial, after de-identification, might be provided (subjected to criteria listed below).
When will data be available (start and end dates)?
Immediately following publication, until 15 years after publication.
Available to whom?
Only research teams who provide a methodologically sound proposal might ask for IPD. Requests will be evaluated on a case-by-case basis at the discretion of the PI.
Available for what types of analyses?
Only for IPD meta-analyses.
How or where can data be obtained?
Access subject to approvals by Principal Investigator (through secure institutional email - [email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8365Ethical approval  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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