Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001234202
Ethics application status
Approved
Date submitted
11/07/2018
Date registered
23/07/2018
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective study of the effectiveness of a structured weaning protocol for ICU patients on High Flow Oxygen (HOW study)
High-flow Oxygen Weaning study
Scientific title
Prospective study of the effectiveness of a structured weaning protocol for ICU patients on High Flow Oxygen (HOW study)
High-flow Oxygen Weaning study
Secondary ID [1] 295505 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
HOW study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
patients requiring supplemental oxygen 308773 0
Condition category
Condition code
Respiratory 307707 307707 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient's treated with high flow nasal oxygen will have the oxygen flow decreased over 10 to 30 minutes according to the weaning protocol created for this study. The initial oxygen concentration (FiO2) will remain constant at the level set by the bedside nurse and the flow decreased stepwise to the minimum effective to meet the target oxygen saturation. The FiO2 will then be set at 100% and the flow further decreased stepwise to the final minimum effective flow rate.

Weaning protocol:
Collect baseline data including: heart rate, oxygen saturation, respiratory rate, flow and FiO2 prior to wean, reason for high flow oxygen therapy, reason for ICU admission, APACHE III score, comfort and dyspnea score. Then commence wean as follows:
• leave the FiO2 at the current setting and decrease the flow by 5L/min in a stepwise fashion.
• Monitor SpO2 for 2 minutes.
• If SpO2 > 93% after 2 minutes, continue stepwise decrease in flow.
• When SpO2 < 93%, cease weaning and return flow to the previous setting
• Change the FiO2 to 100%
• Decrease the flow by 5L/min in a stepwise fashion.
• Monitor SpO2 for 2 minutes.
• If SpO2 > 93% after 2 minutes continue stepwise decrease in flow.
• When SpO2 < 93%, cease weaning and return to previous setting
• Record the final flow rate and repeat physiological measures, dyspnoea and comfort measures.

When the participant is stable on a flow of 10L/min, change to low flow device and decrease flow in increments of 1L until the minimal effective flow is reached.

At the completion of the wean, return the O2 settings to those present at the commencement of the wean and hand over to the nurse caring for the patient.

The intervention will be completed by the principle investigator (Julie O'Donnell) and the Research Nurse at Epworth Richmond (Gabrielle Hanlon) only. Notes will be taken on the data collection form created for the project. The patients oxygen saturations, heart rate, respiratory rate , flow and FiO2 will be documented in 2 minutely intervals during the weaning process. Each step of the protocol will be documented on the data collection form, therefore adherence to the intervention will be monitored and recorded on this form.
Intervention code [1] 301826 0
Treatment: Devices
Comparator / control treatment
no control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306698 0
The proportion of patients successfully weaned from high flow nasal oxygen to standard ( < 15L/min) flow oxygen and maintain oxygen saturations > 93%.

The outcome will be directly supervised. Whether the patient was able to be successfully weaned from high flow nasal oxygen to standard low flow oxygen will be known at the time of the intervention. The total proportion of patients that are successfully weaned will be assessed from the information collected on the data collection form which will be completed by the researchers.
Timepoint [1] 306698 0
At the completion of oxygen flow wean.
Secondary outcome [1] 349290 0
Change in dyspnoea scores (measured using the Borg dyspnoea 10-point score)
Timepoint [1] 349290 0
At the completion of oxygen flow wean.
Secondary outcome [2] 349497 0
Change in comfort (measured on a 0-10 visual- analogue scale)
Timepoint [2] 349497 0
At the completion of oxygen flow wean.
Secondary outcome [3] 349498 0
Change in heart rate. Measured using electrocardiography (ECG) readings
Timepoint [3] 349498 0
At the completion of oxygen flow wean.
Secondary outcome [4] 349499 0
Change in respiratory rate. Respiratory rate measured using ECG lead monitoring.
Timepoint [4] 349499 0
At the completion of oxygen flow wean.
Secondary outcome [5] 349855 0
Safety of the weaning protocol defined as oxygen desaturation requiring medical intervention.
Timepoint [5] 349855 0
At the completion of the oxygen flow wean

Eligibility
Key inclusion criteria
Patients in Epworth Richmond ICU who are receiving High Flow Oxygen via nasal prongs (HFNP).
Patient has been stable on current oxygen settings for at least 4 hours
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients unable to give consent for any reason
• Pregnancy
• Requirement for invasive or non-invasive ventilation
• ICU patients who are receiving end-of-life care.
• Aged < 18 years
• Patients considered unsuitable by treating ICU consultant

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/07/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
73
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11444 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 23456 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 300095 0
Hospital
Name [1] 300095 0
Epworth Healthcare Richmond ICU department
Country [1] 300095 0
Australia
Primary sponsor type
Hospital
Name
Epworth Healthcare Richmond ICU department
Address
89 Bridge Road Richmond VIC 3121
Country
Australia
Secondary sponsor category [1] 299497 0
None
Name [1] 299497 0
Address [1] 299497 0
Country [1] 299497 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300937 0
The Epworth Human Research Ethics Committee
Ethics committee address [1] 300937 0
Ethics committee country [1] 300937 0
Australia
Date submitted for ethics approval [1] 300937 0
Approval date [1] 300937 0
18/06/2018
Ethics approval number [1] 300937 0

Summary
Brief summary
The purpose of this study is to determine the impact of a standardised weaning protocol for high flow O2. The primary outcome measure is the proportion of participants successfully weaned from high to low flow oxygen therapy. The secondary outcome is to determine whether weaning high flow oxygen leads to improved comfort and dyspnoea.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85342 0
Ms Julie O'Donnell
Address 85342 0
Epworth Healthcare Richmond
89 Bridge Road Richmond VIC 3121
Country 85342 0
Australia
Phone 85342 0
+61 3 95063119
Fax 85342 0
Email 85342 0
julie.o'[email protected]
Contact person for public queries
Name 85343 0
Ms Julie O'Donnell
Address 85343 0
Epworth Healthcare Richmond
89 Bridge Road Richmond VIC 3121
Country 85343 0
Australia
Phone 85343 0
+61 3 95063119
Fax 85343 0
Email 85343 0
julie.o'[email protected]
Contact person for scientific queries
Name 85344 0
Ms Julie O'Donnell
Address 85344 0
Epworth Healthcare Richmond
89 Bridge Road Richmond VIC 3121
Country 85344 0
Australia
Phone 85344 0
+61 3 95063119
Fax 85344 0
Email 85344 0
julie.o'[email protected]

No information has been provided regarding IPD availability


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.