Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000932460p
Ethics application status
Submitted, not yet approved
Date submitted
5/08/2025
Date registered
28/08/2025
Date last updated
28/08/2025
Date data sharing statement initially provided
28/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A novel ward-based weaning protocol for High-Flow Nasal Oxygen in an adult population
Scientific title
A novel ward-based weaning protocol for High-Flow Nasal Oxygen in an adult population
Secondary ID [1] 314832 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute respiratory illness 338097 0
Condition category
Condition code
Respiratory 334395 334395 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a protocol for weaning hospital admitted patients from high flow nasal oxygen (HFNO) to low flow nasal oxygen (LFNO) or room air (RA). The protocol is medically supervised and performed by medical or nursing staff with careful and monitored step-by-step guidance. It will be applied to patients recovering from acute respiratory illness who were commenced on HFNO for an acute respiratory illness.

The protocol will have three stages: the order to wean, the weaning period, and the post-wean assessment.

ORDER TO WEAN
A doctor from the treating team will assess the patient on HFNO (e.g. during ward round, but can also occur ad hoc) for the following “criteria to wean”:
- No signs of respiratory distress/"Looks comfortable"
- Clinical judgement of the patient being past the peak of their illness and recovering i.e. clinically ready to wean
- SpO2 92-96% (Alternative SpO2 aims acceptable where clinically appropriate for the individual patient)
- RR =< 25
If the patient meets all criteria, then the doctor initiates an order to wean HFNO. The order will be documented in EMR as a specific note and communicated verbally to nursing staff to commence the weaning period.

WEANING PERIOD
Part 1: Decreasing settings
1. Nurse or doctor decreases both the FiO2 by 10% and flow by 10 L/min simultaneously (to a minimum flow of 30 L/min)
2. Within 30 minutes after the setting reduction, nurse check SpO2, RR, HR, and BP -> if stable continue at the new settings
3. 2 hours after the vital sign check from step 2, nurse check SpO2, RR, HR, and BP -> if stable wean both the FiO2 by 10% and flow by 10L/min
4. Repeat steps 1) to 3) until FiO2 30% is reached
5. 2 hours after being at FiO2 30%, nurse check SpO2, RR, HR, and BP -> if stable move to “Part 2” below
6. At each vital sign check, if any parameters worsen (i.e. deterioration in SpO2, RR, HR, BP) or any of the above “criteria to wean” are lost, or if there are any other clinical concerns -> return to the previous setting and contact a doctor from the treating team for a medical review
a. Doctor will determine if patient still appropriate to continue weaning via protocol (or whether other clinical factors necessitate an separate individualised weaning plan)

Part 2: Separation from HFNO
Once vital signs have been stable for 2 hours on FiO2 30%:
1. Nursing staff contact doctor from treating team OR perform a nursing lead assessment of the patient for the “criteria to wean” (at nursing discretion) then contact a doctor from the treating team for a medical review for formal HFNO separation
2. Doctor assesses patient against the original “criteria to wean” – can be done in person or via chart review at doctor’s discretion as clinically appropriate
3. Doctor calculates the ROX score: (SpO2/FiO2) / RR
4. If all the “criteria to wean” are met and the ROX score is >= 9.2 -> switch patient to LFNO 2 L/min and this to be documented by the doctor on EMR
5. Within 30 minutes after changing to LFNO, nurse checks SpO2, RR, HR, and BP
6. If any vital signs worsen or any “criteria to wean” are lost, or if there are any other clinical concerns, return to HFNO at the last setting
7. HFNO apparatus will remain at the patient’s bedside for at least 4 hours post change to LFNO

POST WEAN ASSESSMENT:
As a secondary outcome a patient will be considered successfully weaned from HFNO if remaining on LFNO/absence or re-escalation to HFNO after 24 hours. At this stage (or earlier), a doctor from the medical team can elect to trial a wean from LFNO to room air as per standard clinical practice.

PATIENT SELECTION AND ALLOCATION:
Included patients in the intervention group (weaning protocol applied) will be those who have been commenced on HFNO for an acute respiratory illness admitted under the Respiratory bed card. Patients in the non-interventional group (weaning protocol not applied) will be those commenced on HFNO for an acute respiratory illness to a General Medicine ward. Screening of ward admission lists and electronic medical records will be conducted by authorised members of the research team to identify patients who meet the inclusion criteria.
Intervention code [1] 331435 0
Treatment: Other
Comparator / control treatment
Participants in the control group with receive usual care, defined as being weaned from HFNO without a protocol according to medical or nursing clinical judgement, which is variable and not standardised. Patients will be weaned to LFNO or room air per treating team and nursing staff, which may take hours to days.
Control group
Active

Outcomes
Primary outcome [1] 342078 0
Total duration of HFNO use
Timepoint [1] 342078 0
At end of HFNO use
Secondary outcome [1] 449485 0
Duration of HFNO wean
Timepoint [1] 449485 0
At end of HFNO use
Secondary outcome [2] 449486 0
Total duration of HFNO use as a proportion of length of stay
Timepoint [2] 449486 0
At end of HFNO use
Secondary outcome [3] 449487 0
Duration of HFNO at a potentially weanable setting
Timepoint [3] 449487 0
At end of HFNO use
Secondary outcome [4] 449488 0
Duration between initiation of LFNO and weaning to room air
Timepoint [4] 449488 0
At end of HFNO use
Secondary outcome [5] 449489 0
Successful wean defined as remaining on LFNO/RA for 24 hours post separation from HFNO
Timepoint [5] 449489 0
At end of HFNO use
Secondary outcome [6] 449490 0
Length of stay
Timepoint [6] 449490 0
At time of discharge
Secondary outcome [7] 449491 0
Time to ambulation
Timepoint [7] 449491 0
Prior to or at end of HFNO use

Eligibility
Key inclusion criteria
Hospital admitted patients commenced on HFNO for an acute respiratory illness.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Commenced on HFNO for type two respiratory failure.
Commenced on HFNO as bridging therapy between stints of non-invasive ventilation.
Commenced on HFNO for reasons other than acute respiratory illness e.g. routine post-extubation.

Study design
Purpose of the study
Educational / counselling / training
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
24/11/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 319392 0
Self funded/Unfunded
Name [1] 319392 0
Country [1] 319392 0
Primary sponsor type
Hospital
Name
Monash Medical Centre - Monash Lung and Sleep
Address
Country
Australia
Secondary sponsor category [1] 321878 0
None
Name [1] 321878 0
Address [1] 321878 0
Country [1] 321878 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317966 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 317966 0
Ethics committee country [1] 317966 0
Australia
Date submitted for ethics approval [1] 317966 0
23/07/2025
Approval date [1] 317966 0
Ethics approval number [1] 317966 0

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

Contacts
Principal investigator
Name 142714 0
Dr Huy Vu
Address 142714 0
Monash Lung and Sleep, Monash Medical Centre, 246 Clayton Rd, Clayton VIC 3168
Country 142714 0
Australia
Phone 142714 0
+61 3 9594 2900
Fax 142714 0
Email 142714 0
[email protected]
Contact person for public queries
Name 142715 0
Huy Vu
Address 142715 0
Monash Lung and Sleep, Monash Medical Centre, 246 Clayton Rd, Clayton VIC 3168
Country 142715 0
Australia
Phone 142715 0
+61 3 9594 2900
Fax 142715 0
Email 142715 0
[email protected]
Contact person for scientific queries
Name 142716 0
Huy Vu
Address 142716 0
Monash Lung and Sleep, Monash Medical Centre, 246 Clayton Rd, Clayton VIC 3168
Country 142716 0
Australia
Phone 142716 0
+61 3 9594 2900
Fax 142716 0
Email 142716 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.