ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Oxygen desaturation during endoscopic procedures

Airway management

Condition category

Condition code

Anaesthesiology

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]

Treatment: Devices

Intervention code [2]

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]

Comparison of moderate oxygen desaturation rates (<90%) between the two groups, assessed through a finger pulse oximeter.

Timepoint [1]

Calculated per patient, summarised at the end of each endoscopy procedure by the anaesthetist and endoscopist.

Secondary outcome [1]

Comparison of variable oxygen desaturation rates (e.g. 94%, 92%) between the two groups, assessed through a finger pulse oximeter.

Timepoint [1]

Assessed per patient, summarised at the end of each endoscopy procedure by the anaesthetist and endoscopist.

Secondary outcome [2]

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]

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?

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]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [2]

Austin Health - Heidelberg Repatriation Hospital - Heidelberg West

Recruitment postcode(s) [1]

3084 - Heidelberg

Recruitment postcode(s) [2]

3081 - Heidelberg West

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Health

Address [1]

Austin Health
Anaesthesiology Department
Gastroenterology Department
145 Studley Road, Heidelberg VIC 3084

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

145 Studley Road, Heidelberg VIC 3084

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Leonardo Zorron Cheng Tao Pu

Address [1]

Austin Health
Gastroenterology Department
145 Studley Road, Heidelberg VIC 3084

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

Austin Health 
145 Studley Road, Heidelberg, VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

29/06/2020

Ethics approval number [1]

HREC/63130/Austin-2020

Summary

Brief summary

Doctors currently examine the human gastrointestinal tract using a device called an endoscope, which contains a camera that enables the doctor to view and treat diseases from within the gastrointestinal tract. Most endoscopic procedures are done under sedation, what means that people are put asleep during such procedures by an Anaesthetist. During the examination, it is costumery that the patients' breathing capabilities become mildly impaired. For this reason, the Anaesthetists utilise supplementary oxygen to avoid the oxygen levels in your blood getting too low. Although we know that using some supplementary oxygen is better than using none, it is still under debate what is the ideal amount (or flow) of oxygen that should be used to avoid the loss of oxygenation. The purpose of this study is to determine whether two devices that deliver two different flows of oxygen (standard nasal cannula - 2 L/min or high-flow mouthguard - 20L/min) are similar or different in preventing the loss of oxygenation while under sedation for short endoscopic procedures.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Leonardo Zorron Cheng Tao Pu

Address

Austin Health
Gastroenterology Department
145 Studley Road, Heidelberg, VIC 3084

Country

Australia

Phone

+61 433 930 442

Fax

leo.zorronchengtaopu@austin.org.au

Contact person for public queries

Name

Leonardo Zorron Cheng Tao Pu

Address

Austin Health
Gastroenterology Department
145 Studley Road, Heidelberg, VIC 3084

Country

Australia

Phone

+61 433 930 442

Fax

leo.zorronchengtaopu@austin.org.au

Contact person for scientific queries

Name

Leonardo Zorron Cheng Tao Pu

Address

Austin Health
Gastroenterology Department
145 Studley Road, Heidelberg, VIC 3084

Country

Australia

Phone

+61 433 930 442

Fax

leo.zorronchengtaopu@austin.org.au

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 - leo.zorronchengtaopu@austin.org.au)

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
8365	Ethical approval			leo.zorronchengtaopu@austin.org.au

Results publications and other study-related documents

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No additional documents have been identified.

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