Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001262695
Ethics application status
Approved
Date submitted
1/11/2023
Date registered
5/12/2023
Date last updated
27/10/2024
Date data sharing statement initially provided
5/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Oxygen delivery devices in bronchoscopy procedures and the effect on oxygenation
Scientific title
High flow nasal oxygen therapy versus conventional oxygen therapy in patients undergoing bronchoscopy and the effect on oxygenation: a randomised controlled trial
Secondary ID [1] 311029 0
Nil known
Universal Trial Number (UTN)
U1111-1299-6882
Trial acronym
OXYBRONCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoxia/desaturations during bronchoscopy 331909 0
Comfort of oxygen delivery devices during bronchoscopy procedures 331910 0
Condition category
Condition code
Respiratory 328643 328643 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High flow nasal oxygen therapy (HFNO) via Airvo 3 device (Fisher & Paykel, Auckland New Zealand) during diagnostic bronchoscopy procedures (standard and endobronchial ultrasound guided).

Stratum one: Intention for bronchoscopy via nasal route
- Intervention: High flow nasal oxygen via single nasal cannula into one nasal cavity

Stratum two: Intention for endobronchial-ultrasound (EBUS) via oral route
- Intervention: High flow nasal oxygen via dual nasal cannula into both nasal cavities

The Aivo3 device has a power supply and oxygen source and delivers high flow humidified air mixed with oxygen, It is connected to a single prong or dual prong nasal cannula depending on the procedure the participant is undergoing (stratum one or stratum two) and delivers the therapy via the nose with a strap around the participant's head holding the cannula in place. The difference between the interventions in each stratum is that the nasal cannula interface provides the oxygen therapy via one verus two nasal cavities. The single and dual cannula will provide the same flow rate (L/min) and oxygen concentration.

The duration of the intervention is less than one hour. It includes the length of the bronchoscopy or EBUS procedure (approximately 10-25 minutes for standard bronchoscopy and 25-40 minutes for EBUS) and approximately 5 minutes pre and post procedure when the oxygen devices are attached/removed and pre-procedure sedation is given. The procedures are different between the strata with stratum one passing the bronchoscope via the nose and performing a combination of washings, brushings and endobronchial biopsies and stratum two passing the bronchoscope via the mouth and performing endobronchial ultrasound guided transbronchial needle aspirations (EBUS-TBNA).

The intervention will be administered by respiratory physicians. Adherence to the intervention will be documented on a participant case report form. The starting fraction of inspired oxygen (FiO2) will be set at 28% via the Airvo 3 device and the flow rate will be set at 40L/min.

The respiratory physicians performing the procedures can adjust the FiO2 throughout the procedure as required. These changes will be recorded. The flow rate will be constant.
Intervention code [1] 327287 0
Treatment: Devices
Comparator / control treatment
Conventional low flow oxygen therapy (COT)

Stratum one: Intention for bronchoscopy via nasal route
- Control: Dual low flow nasal cannula into mouth

Stratum two: Intention for endobronchial-ultrasound (EBUS) via oral route
- Control: Dual low flow nasal cannula into both nasal cavities

The starting oxygen flow will be set at 2L/min. This can be increased as required by the respiratory physician performing the procedure and these changes will be documented on the participant case report form.
Control group
Active

Outcomes
Primary outcome [1] 336440 0
Time with SpO2 <90% during bronchoscopy
Timepoint [1] 336440 0
At any point during bronchoscopy - from the point that the monitoring device is attached to the point at which it is removed. Continuous SpO2 monitoring throughout procedure.
Secondary outcome [1] 428413 0
Number of desaturations
Timepoint [1] 428413 0
At any point during bronchoscopy - from the point that the monitoring device is attached to the point at which it is removed. Continuous SpO2 monitoring throughout procedure.
Secondary outcome [2] 428414 0
Lowest oxygen saturations during bronchoscopy
Timepoint [2] 428414 0
At any point during bronchoscopy - from the point that the monitoring device is attached to the point at which it is removed. Continuous SpO2 monitoring throughout procedure.
Secondary outcome [3] 428415 0
Average oxygen saturations during bronchoscopy
Timepoint [3] 428415 0
Duration of procedure. Continuous monitoring throughout.
Secondary outcome [4] 428416 0
Manual oxygen titration frequency
Timepoint [4] 428416 0
Total number calculated from manual documentation immediately after procedure
Secondary outcome [5] 428417 0
Procedure interruptions
Timepoint [5] 428417 0
Immediately after procedure
Secondary outcome [6] 428418 0
Procedure discontinuation
Timepoint [6] 428418 0
Immediately after procedure
Secondary outcome [7] 428419 0
Procedure time
Timepoint [7] 428419 0
Duration calculated from start and end timestamps on case report form immediately after end of procedure
Secondary outcome [8] 428420 0
Acceptability of oxygen delivery devices during bronchoscopy to clinicians
Timepoint [8] 428420 0
Within 15 minutes of end of procedure
Secondary outcome [9] 428421 0
Comfort of oxygen delivery devices during bronchoscopy to patients
Timepoint [9] 428421 0
Within 15 minutes of end of procedure when patient is alert
Secondary outcome [10] 428422 0
Cough frequency during bronchoscopy
Timepoint [10] 428422 0
Duration of procedure. Continuous monitoring throughout.

Eligibility
Key inclusion criteria
• Age 18 years or older
• Indication for diagnostic bronchoscopy (standard bronchoscopy or EBUS guided)
• Pre-procedure intent to insert bronchoscope via the nose in the standard bronchoscopy group (stratum one)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Not able to consent
• Patient is in ICU
• Patient is in theatre
• Patient is intubated
• Patient has a tracheostomy
• Pre-procedure intent to insert bronchoscope via the mouth in the standard bronchoscopy group (stratum one)

Study design
Purpose of the study
Treatment
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)
Computer generated sets of random allocations
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We intend to recruit 60 participants into each of the 2 randomised groups (HFNO and COT), 120 in total. This will enable differences in the means between the two randomised groups for the primary outcome, the duration of SpO2 less than 90%, of approximately 25 seconds to be detected as statistically significant (2-tailed a=0.05) with 90% power.

The randomisation is stratified into nasal bronchoscopy (stratum one) and EBUS (stratum two) groups and it is anticipated that approximately two thirds of the participants will be in the nasal bronchoscopy group (stratum one). The sensitivity analyses within each of these strata will have 80% power to detect differences in the means of approximately 25 seconds and 30 seconds for the nasal bronchoscopy (stratum one) and EBUS (stratum two) respectively.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/01/2024
Actual
9/01/2024
Date of last participant enrolment
Anticipated
Actual
26/07/2024
Date of last data collection
Anticipated
Actual
26/07/2024
Sample size
Target
120
Accrual to date
Final
133
Recruitment outside Australia
Country [1] 25931 0
New Zealand
State/province [1] 25931 0
Christchurch

Funding & Sponsors
Funding source category [1] 315129 0
Self funded/Unfunded
Name [1] 315129 0
Country [1] 315129 0
Primary sponsor type
Individual
Name
Georgia Burton
Address
Christchurch Hospital, 2 Riccarton Avenue, Christchurch Central City, Christchurch 4710
Country
New Zealand
Secondary sponsor category [1] 317145 0
None
Name [1] 317145 0
Address [1] 317145 0
Country [1] 317145 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314068 0
Southern Health and Disability Ethics Commitee
Ethics committee address [1] 314068 0
Ethics committee country [1] 314068 0
New Zealand
Date submitted for ethics approval [1] 314068 0
01/11/2023
Approval date [1] 314068 0
20/12/2023
Ethics approval number [1] 314068 0
2023 FULL 18502

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

Contacts
Principal investigator
Name 130290 0
Dr Georgia Burton
Address 130290 0
Christchurch Hospital, 2 Riccarton Avenue, Christchurch Central City, Christchurch 4710
Country 130290 0
New Zealand
Phone 130290 0
+64 276361144
Fax 130290 0
Email 130290 0
[email protected]
Contact person for public queries
Name 130291 0
Georgia Burton
Address 130291 0
Christchurch Hospital, 2 Riccarton Avenue, Christchurch Central City, Christchurch 4710
Country 130291 0
New Zealand
Phone 130291 0
+64 276361144
Fax 130291 0
Email 130291 0
[email protected]
Contact person for scientific queries
Name 130292 0
Georgia Burton
Address 130292 0
Christchurch Hospital, 2 Riccarton Avenue, Christchurch Central City, Christchurch 4710
Country 130292 0
New Zealand
Phone 130292 0
+64 276361144
Fax 130292 0
Email 130292 0
[email protected]

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


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.