Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000658819
Ethics application status
Approved
Date submitted
25/03/2021
Date registered
31/05/2021
Date last updated
6/06/2023
Date data sharing statement initially provided
31/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Automatic versus manual oxygen titration using a novel nasal high-flow oxygen delivery device in hospitalised adults in the intensive care unit following elective cardiothoracic surgery
Scientific title
Single blinded parallel group, phase IIB randomised controlled trial of automatic versus manual oxygen titration using a novel nasal high-flow oxygen delivery device in hospitalised adults in the intensive care unit following elective cardiothoracic surgery
Secondary ID [1] 303786 0
Protocol Number: MRINZ/21/01
Universal Trial Number (UTN)
Trial acronym
AIRVO3: Post-Cardiothoracic
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative cardiothoracic patients requiring oxygen therapy 321285 0
Condition category
Condition code
Respiratory 319070 319070 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nasal High Flow therapy using the AIRVO3 device with automatic oxygen titration

Participants will be randomised prior to extubation by study investigators with a minimum of 2 years clinical experience. The AIRVO3 device will be set up on automatic oxygen titration mode and will be used by trained doctors and nurses in the intensive care unit. A pulse oximeter sensor will be attached to the participant's finger which will provide feedback to the AIRVO3 device. In addition to monitoring SpO2 via the AIRVO3, the patient will have SpO2 monitored using a standard ICU pulse oximeter.

The AIRVO3 device will be set to automatic oxygen titration mode with a target SpO2 between 92 and 96%. A study investigator will set the initial FiO2 to maintain SpO2 within target range. The FiO2 which maintains the participant’s SpO2 at the mid-point of the target range (94%) will be set as the mid-point for the appropriate FiO2 range. For example, if 0.30 FiO2 was required to maintain and SpO2 of 94% for a participant with the target SpO2 of 92-96%, the FiO2 range 0.25-0.35 would be selected.

Participants randomised to automatic oxygen titration will receive NHF therapy using the AIRVO3 device with automatic oxygen titration until whichever of the following occurs first: FiO2 at 0.21 for one continuous hour, 24 hours therapy, SaO2 of clinical concern when the SpO2 recorded on the AIRVO3 device is within the target range, or discharge from ICU, or withdrawn from the study.

All other aspects of medical care will continue as usual during the study period.
Intervention code [1] 320444 0
Treatment: Devices
Comparator / control treatment
Nasal High Flow therapy using the AIRVO3 device with manual oxygen titration

Participants will be randomised prior to extubation by study investigators with a minimum of 2 years clinical experience. The AIRVO3 device will be set up on manual oxygen titration mode and will be used by trained doctors and nurses in the intensive care unit. A pulse oximeter sensor will be attached to the participant's finger which will provide feedback to the AIRVO3 device. In addition to monitoring SpO2 via the AIRVO3, the patient will have SpO2 monitored using a standard ICU pulse oximeter.

The AIRVO3 device will be set to manual oxygen titration mode with a target SpO2 between 92 and 96%. ICU staff will be instructed to titrate oxygen according to usual clinical practice. This will be through manually increasing or decreasing the FiO2 being delivered to achieve the target SpO2.

Participants randomised to manual oxygen titration will receive NHF therapy using the AIRVO3 device with manual oxygen titration until whichever of the following occurs first: FiO2 at 0.21 for one continuous hour, 24 hours therapy, SaO2 of clinical concern when the SpO2 recorded on the AIRVO3 device is within the target range, or discharge from ICU, or withdrawn from the study.

All other aspects of medical care will continue as usual during the study period.
Control group
Active

Outcomes
Primary outcome [1] 326961 0
Percentage of time spent during treatment period with SpO2 in target range as recorded by the AIRVO3 device
Timepoint [1] 326961 0
End of treatment period
Secondary outcome [1] 393306 0
Percentage of time spent during treatment period with SpO2 above target range as recorded by the AIRVO3 device
Timepoint [1] 393306 0
End of treatment period
Secondary outcome [2] 393307 0
Graph of distribution of SpO2 as recorded by the AIRVO3 device
Timepoint [2] 393307 0
End of treatment period
Secondary outcome [3] 393308 0
Minimum respiratory rate as recorded by the AIRVO3 device
Timepoint [3] 393308 0
End of treatment period
Secondary outcome [4] 393310 0
Minimum FiO2 as recorded by the AIRVO3 device
Timepoint [4] 393310 0
End of treatment period
Secondary outcome [5] 393311 0
Number times FiO2 manually changed /adjusted as recorded by the AIRVO3 device
Timepoint [5] 393311 0
End of treatment period
Secondary outcome [6] 394886 0
Percentage of time spent during treatment period with SpO2 below target range as recorded by the AIRVO3 device
Timepoint [6] 394886 0
End of treatment period
Secondary outcome [7] 394887 0
Minimum SpO2 as recorded by the AIRVO3 device
Timepoint [7] 394887 0
End of treatment period
Secondary outcome [8] 394888 0
Maximum SpO2 as recorded by the AIRVO3 device
Timepoint [8] 394888 0
End of treatment period
Secondary outcome [9] 394889 0
Mean SpO2 as recorded by the AIRVO3 device
Timepoint [9] 394889 0
End of treatment period
Secondary outcome [10] 394890 0
Maximum respiratory rate as recorded by the AIRVO3 device
Timepoint [10] 394890 0
End of treatment period
Secondary outcome [11] 394891 0
Mean respiratory rate as recorded by the AIRVO3 device
Timepoint [11] 394891 0
End of treatment period
Secondary outcome [12] 394892 0
Maximum FiO2 as recorded by the AIRVO3 device
Timepoint [12] 394892 0
End of treatment period
Secondary outcome [13] 394893 0
Mean estimated FiO2 as recorded by the AIRVO3 device
Timepoint [13] 394893 0
End of treatment period

Eligibility
Key inclusion criteria
- Elective cardiac surgery with postoperative ICU care
- Deemed clinically ready for extubation in the ICU following cardiac surgery
- Target SpO2 of 92-96% documented by clinical team
- PaO2/FiO2 ratio of <350 prior to extubation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Age < 18
• Presence of any risk factor for hypercapnic respiratory failure including: COPD, cystic fibrosis, bronchiectasis, chest wall deformity or neuromuscular disease AND investigator considers 92-96% to be an inappropriate SpO2 target
• There is a discrepancy between the arterial blood oxygen saturation level with the SpO2 value which is of clinical concern prior to extubation
• Evidence of respiratory infection or colonization with multidrug resistant bacteria, Pseudomonas species, Burkholderia Cepacia or mycobacteria
• Patient not expected to survive hospital admission or being treated with palliative intent
• Nasal or facial conditions precluding use of NHF
• Intracranial trauma or trans-nasal neurosurgery (within 6 weeks)
• Any condition which limits the feasibility of continuous SpO2 monitoring using a finger probe such as anatomical deformity or vascular compromise
• Pregnancy or breastfeeding
• Cognitive impairment or impaired consciousness precluding informed consent
• Any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results

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)
The randomisation schedule will be concealed from study investigators within the REDCap database. The treatment to which each participant is randomised will be automatically displayed by REDCap for each recruited participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised in equal proportions i.e. one-to-one, to intervention and control groups. The randomization schedule will be computer generated by the study statistician and incorporated into the REDCap study database.
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
Efficacy
Statistical methods / analysis
Based on a previous medical inpatient study, we estimate a total sample size of 50 participants will provide 90% power to detect a 13% difference in time spent in target range between intervention and control, based on an SD of 14. The sample size calculations are based on using an unpaired t-test to compare groups, equal size numbers in intervention and control groups, and a two sided Type I error rate (alpha) of 5%. Allowing for a dropout/withdrawal rate of 10%, a total of 56 participants will be studied.

The primary analysis will be a general linear model (ANCOVA); with predictor variables of baseline SpO2 and the randomised treatment. If there is a skewed distribution, a Wilcoxon rank-based method with the Hodges-Lehmann estimator for location difference and appropriate confidence intervals will be used for all outcomes relating to SpO2.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/07/2021
Actual
30/09/2021
Date of last participant enrolment
Anticipated
17/01/2022
Actual
19/12/2022
Date of last data collection
Anticipated
18/01/2022
Actual
20/12/2022
Sample size
Target
56
Accrual to date
Final
56
Recruitment outside Australia
Country [1] 23563 0
New Zealand
State/province [1] 23563 0
Wellington

Funding & Sponsors
Funding source category [1] 308189 0
Commercial sector/Industry
Name [1] 308189 0
Fisher and Paykel Healthcare
Country [1] 308189 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
15 Maurice Paykel Place, East Tamaki, Auckland, New Zealand. Auckland 2013
Country
New Zealand
Secondary sponsor category [1] 308968 0
None
Name [1] 308968 0
Address [1] 308968 0
Country [1] 308968 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308172 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 308172 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 308172 0
New Zealand
Date submitted for ethics approval [1] 308172 0
16/04/2021
Approval date [1] 308172 0
13/05/2021
Ethics approval number [1] 308172 0
21/NTB/103

Summary
Brief summary
This study is investigating a new oxygen delivery device which automatically adjusts the amount of oxygen it gives. A finger sensor is connected to the device and continuously measures the amount of oxygen in the blood. Based on this measurement, the device can increase or decrease the amount of oxygen to keep blood oxygen levels in the correct range. The device has been developed by Fisher and Paykel Healthcare (FPH) and is called AIRVO3.

The main aim of the study is to find out whether automatic oxygen adjustment by the AIRVO3 device keeps blood oxygen levels in the correct range for a greater amount of time compared to the usual way of adjustment by doctors and nurses. We will test this over a period of 24 hours.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109794 0
Dr Louis Kirton
Address 109794 0
Medical Research Institute of New Zealand
Level 7, Clinical Services Building
Wellington Hospital
Riddiford Street Newtown
Wellington 6021
New Zealand
Country 109794 0
New Zealand
Phone 109794 0
+64 4 8050268
Fax 109794 0
Email 109794 0
[email protected]
Contact person for public queries
Name 109795 0
Louis Kirton
Address 109795 0
Medical Research Institute of New Zealand
Level 7, Clinical Services Building
Wellington Hospital
Riddiford Street Newtown
Wellington 6021
New Zealand
Country 109795 0
New Zealand
Phone 109795 0
+64 4 8050268
Fax 109795 0
Email 109795 0
[email protected]
Contact person for scientific queries
Name 109796 0
Paul Young
Address 109796 0
Wellington Regional Hospital
Intensive Care Unit
Riddiford Street, Newtown
Wellington 6021
New Zealand
Country 109796 0
New Zealand
Phone 109796 0
+64 4 806 0446
Fax 109796 0
Email 109796 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?
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
When will data be available (start and end dates)?
One year after publication until a minimum of 5 years after publication.
Available to whom?
Researchers who provide a methodologically sound proposal that has been approved by the study steering committee and sponsor.
Available for what types of analyses?
To achieve the aims outlined in the approved proposal.
How or where can data be obtained?
Through a signed data access agreement and subject to approval by the principal investigator ([email protected]) and the study sponsor (kevin.o'[email protected])


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.