Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001420831
Ethics application status
Approved
Date submitted
23/08/2021
Date registered
21/10/2021
Date last updated
23/09/2022
Date data sharing statement initially provided
21/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Patient responses to oxygen therapy (PROT)
Scientific title
Patient responses to oxygen therapy in those admitted to the intensive care unit requiring oxygen therapy delivered by a ventilator
Secondary ID [1] 305111 0
None
Universal Trial Number (UTN)
Trial acronym
PROT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute illness requiring oxygen therapy delivered by a ventilator 323332 0
Condition category
Condition code
Respiratory 320897 320897 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observation study measuring physiological responses in patients on oxygen therapy via a ventilator within the ICU.
This study will only include participants who are receiving oxygen therapy with non-invasive ventilatory support (such as NHF and CPAP mode).
The participants' oxygen saturation (SpO2) responses to changes in the fraction of inspired oxygen (FiO2) will be measured for up to 24 hours.
Participants will receive standard care as usual, the only difference is that they will wear an additional pulse oximeter which connects to a data logging machine. This data logging machine will be used to continuously measure the SpO2 and FiO2 during the 24-hour observational period. The assessment of these responses may begin at any time as participants will already be receiving oxygen therapy via a ventilator at the time of screening and enrolment. These responses will be monitored by ICU staff, who may adjust the FiO2 depending on the participants oxygen requirements, in which these FiO2 changes will be recorded by the data logging machine during the study period.
Demographics and medical history will be collected at baseline.
Intervention code [1] 321502 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328689 0
Patients’ SpO2 responses to FiO2 changes. The SpO2 will be assessed with a pulse oximeter.
Timepoint [1] 328689 0
Monitored continuously within the 24 hour observational period.
Secondary outcome [1] 399966 0
N/A
Timepoint [1] 399966 0
N/A

Eligibility
Key inclusion criteria
1. Indication of hypoxemia (saturation below target range) requiring supplemental oxygen
2. 16 years or older
3. Provision of signed and dated informed consent form
4. Stated willingness to comply with all study procedures and availability for the duration of the study
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy or lactation
2. Known allergic reactions to or contraindications to components of the study intervention
3. Involvement in another investigational study at the same time that may affect the results of this present study
4. Patients who are intubated

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
9
Final
Recruitment outside Australia
Country [1] 24055 0
New Zealand
State/province [1] 24055 0

Funding & Sponsors
Funding source category [1] 309501 0
Commercial sector/Industry
Name [1] 309501 0
Fisher & Paykel Healthcare
Country [1] 309501 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare
Address
15 Maurice Paykel Place
East Tamaki
Auckland 2013
New Zealand
Country
New Zealand
Secondary sponsor category [1] 310481 0
None
Name [1] 310481 0
None
Address [1] 310481 0
None
Country [1] 310481 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309287 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 309287 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 309287 0
New Zealand
Date submitted for ethics approval [1] 309287 0
01/07/2021
Approval date [1] 309287 0
23/07/2021
Ethics approval number [1] 309287 0
21/NTA/96

Summary
Brief summary
The aim of this observational study is to measure physiological therapeutic responses in patients on oxygen therapy via a ventilator within the ICU at Middlemore Hospital. In addition, data from the participant’s notes and observation charts will be collected.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113634 0
Dr Tony Williams
Address 113634 0
Middlemore Hospital,
100 Hospital Road,
Otahuhu,
Auckland 2025
Country 113634 0
New Zealand
Phone 113634 0
+6492760112
Fax 113634 0
Email 113634 0
twilliams@middlemore.co.nz
Contact person for public queries
Name 113635 0
Dr Tony Williams
Address 113635 0
Middlemore Hospital,
100 Hospital Road,
Otahuhu,
Auckland 2025
Country 113635 0
New Zealand
Phone 113635 0
+6492760112
Fax 113635 0
Email 113635 0
twilliams@middlemore.co.nz
Contact person for scientific queries
Name 113636 0
Dr Tony Williams
Address 113636 0
Middlemore Hospital,
100 Hospital Road,
Otahuhu,
Auckland 2025
Country 113636 0
New Zealand
Phone 113636 0
+6492760112
Fax 113636 0
Email 113636 0
twilliams@middlemore.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There are no plans to publish any aspects of this trial in a form accessible to the general public. All data collected will be de-identified by the sponsor and stored on a secure internal (Fisher & Paykel Healthcare) network. Trial results will be reported to Fisher & Paykel Healthcare for use in internal reports.


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.