Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000874415p
Ethics application status
Submitted, not yet approved
Date submitted
22/01/2025
Date registered
12/08/2025
Date last updated
12/08/2025
Date data sharing statement initially provided
12/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Exhaled CO2 sampling during GI Endoscopy Procedures
Scientific title
An Investigation of Exhaled Carbon Dioxide Sampling in Participants Receiving High-Flow Nasal Oxygen (HFNO) During Gastrointestinal (GI) Endoscopic Procedures
Secondary ID [1] 313781 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Airway management 336405 0
Condition category
Condition code
Anaesthesiology 332928 332928 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The investigational device is an exhaled CO2 sampling device (CO2-sampler) connected to a capnograph. The CO2-sampler is attached to nasal prongs delivering standard HFNO. The participant will be fitted with the investigational device by the clinical team immediately before the procedure. The investigational device will be on the participant throughout their endoscopic procedure (ranging from 15 mins to 1 hour). Each participant will have the investigational device in situ during their endoscopy procedure only, the investigational device will not be used during any other part of their hospital stay. The anaesthetist will closely observe and monitor the participant throughout their procedure. Adherence to the study will be closely observed by a study team member and notes will be recorded on the study CRF.
Different iterations of the investigational device will be included in the study, with each new iteration available approximately 2 months after the use of the first iteration. The first iteration of the sampling device has four small capnography sampling tubes that are attached to HFNO prongs so that there is a sampling tube near each nostril and at each side of the mouth. Subsequent iterations of the sampling device are not predefined and will be modified based on the data collected from the first iteration. All subsequent iterations will include HFNO prongs with one or more capnography samping lines attached positioned near the participants mouth or nose. It is anticipated approximatley five iterations will be included and each will be studied in between 5 and 20 participants.
Intervention code [1] 330368 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340461 0
Detection of end-tidal carbon dioxide (EtCO2).
Timepoint [1] 340461 0
Continuously throughout the participant's GI endoscopy procedure
Secondary outcome [1] 444162 0
Respiratory rate
Timepoint [1] 444162 0
This will be collected continuously throughout the participant's GI endoscopy procedure
Secondary outcome [2] 449690 0
The number of apneic episodes
Timepoint [2] 449690 0
This will be collected continuously throughout the participant's GI endoscopy procedure
Secondary outcome [3] 449691 0
Instances of airway obstruction
Timepoint [3] 449691 0
This will be collected continuously throughout the participant's GI endoscopy procedure
Secondary outcome [4] 449692 0
Oxygen saturation (SpO2)
Timepoint [4] 449692 0
This will be collected continuously throughout the participant's GI endoscopy procedure
Secondary outcome [5] 449693 0
Heart rate
Timepoint [5] 449693 0
This will be collected continuously throughout the participant's GI endoscopy procedure
Secondary outcome [6] 449694 0
Non-invasive blood pressure (NIBP)
Timepoint [6] 449694 0
This will be collected continuously throughout the participant's GI endoscopy procedure
Secondary outcome [7] 449695 0
Anaesthetic medications administered (drug, dose and time)
Timepoint [7] 449695 0
This will be collected continuously throughout the participant's GI endoscopy procedure
Secondary outcome [8] 449696 0
Number of interactions / adjustments to the investigational device
Timepoint [8] 449696 0
This will be collected continuously throughout the participant's GI endoscopy procedure
Secondary outcome [9] 449697 0
Adverse events related to the investigational device (ADE) (e.g. skin abrasion or irritation)
Timepoint [9] 449697 0
This will be collected continuously throughout the participant's GI endoscopy procedure
Secondary outcome [10] 449698 0
Serious adverse events (SAEs)
Timepoint [10] 449698 0
This will be collected continuously throughout the participant's GI endoscopy procedure
Secondary outcome [11] 449776 0
Instances of airway maneuver(s)
Timepoint [11] 449776 0
This will be collected continuously throughout the participant's GI endoscopy procedure
Secondary outcome [12] 449777 0
Instances of procedural interruption(s)
Timepoint [12] 449777 0
This will be collected continuously throughout the participant's GI endoscopy procedure
Secondary outcome [13] 450235 0
The duration of apnoeic episodes
Timepoint [13] 450235 0
This will be collected continuously throughout the participant's GI endoscopy procedure

Eligibility
Key inclusion criteria
- Adult participants (aged 16 years or above)
- Undergoing gastrointestinal (GI) endoscopy procedures under anaesthetist-led sedation
- Participant's anaesthetist willing to use HFNO for the case
- Willing and able to provide informed consent
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any underlying medical condition that, in the opinion of the participant's clinicians, will be unfavourable for the administration of the oxygen flows specified in the protocol or may impair compliance with the conduct of the investigation

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/08/2025
Actual
Date of last participant enrolment
Anticipated
2/11/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 26838 0
New Zealand
State/province [1] 26838 0
Auckland

Funding & Sponsors
Funding source category [1] 318247 0
Commercial sector/Industry
Name [1] 318247 0
Fisher & Paykel Healthcare
Country [1] 318247 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare
Address
Country
New Zealand
Secondary sponsor category [1] 320631 0
None
Name [1] 320631 0
Address [1] 320631 0
Country [1] 320631 0
Other collaborator category [1] 283375 0
University
Name [1] 283375 0
The University of Auckland
Address [1] 283375 0
Country [1] 283375 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316886 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 316886 0
Ethics committee country [1] 316886 0
New Zealand
Date submitted for ethics approval [1] 316886 0
02/07/2025
Approval date [1] 316886 0
Ethics approval number [1] 316886 0

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

Contacts
Principal investigator
Name 139322 0
Prof Alan Merry
Address 139322 0
Dept Anaesthesia , FMHS , University of Auckland, 22 Park Avenue Grafton, Auckland 1023
Country 139322 0
New Zealand
Phone 139322 0
+64 21 492 297
Fax 139322 0
Email 139322 0
[email protected]
Contact person for public queries
Name 139323 0
Jane O'Donnell
Address 139323 0
Dept Anaesthesia , FMHS , University of Auckland, 22 Park Avenue Grafton, Auckland 1023
Country 139323 0
New Zealand
Phone 139323 0
+64 21 563 836
Fax 139323 0
Email 139323 0
[email protected]
Contact person for scientific queries
Name 139324 0
Jane O'Donnell
Address 139324 0
Dept Anaesthesia , FMHS , University of Auckland, 22 Park Avenue Grafton, Auckland 1023
Country 139324 0
New Zealand
Phone 139324 0
+64 21 563 836
Fax 139324 0
Email 139324 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.