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Patient responses to oxygen therapy (PROT)

Patient responses to oxygen therapy in those admitted to the intensive care unit requiring oxygen therapy delivered by a ventilator

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621001420831
Acronym
PROT
Enrollment
20
Registered
2021-10-21
Start date
2021-10-18
Completion date
2023-04-12
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Fisher & Paykel Healthcare
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026