Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000378921p
Ethics application status
Not yet submitted
Date submitted
16/01/2020
Date registered
19/03/2020
Date last updated
19/03/2020
Date data sharing statement initially provided
19/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient responses to nasal high flow therapy (PRNHFT): a pilot study
Scientific title
Patient responses to nasal high flow therapy (PRNHFT): a pilot study
Secondary ID [1] 300281 0
None
Universal Trial Number (UTN)
Trial acronym
PRNHFT study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory distress 315861 0
Condition category
Condition code
Respiratory 314140 314140 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To create a database of physiological therapeutic responses to changes in FiO2 as captured by an inline data collecting box, for patients whilst on AIRVO2
MATERIALS
AIRVO2 flow source and Nasal High Flow cannula. An inline monitor will be installed in the circuit
PROCEDURES
All normal cares will prevail. One exception is the patient must wear a second independent SpO2 monitoring device on one of their fingers (Massimo SpO2 monitor a fully released and marketed device). The second device shall be worn continuously whilst on ARIVO therapy for a maximum of 10 days average expected to be less then 48hrs (based on historical data))
WHO
Consented Adult ICU patients with a requirement for respiratory support (delivered by AIRVO using nasal high flow cannula) as determined by the clinician in charge of their care. No other individual will be involved in the care of these patients
DELIVERY
All usual care shall prevail. The NHF shall be delivered by the ICU staff ( nurses and Drs)
DURATION
The therapy duration shall prevail as per standard care and by clinical need as determined by the clinician in charge of their care
Intervention code [1] 316553 0
Treatment: Devices
Intervention code [2] 316554 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322531 0
Change in patients physiology (respiratory)

SpO2 as assessed by pulse oximetry
Timepoint [1] 322531 0
For each % FiO2 therapy change - maximum duration of ten days (whilst on AIRVO therapy but expected to be 48Hours based on historical data))
FiO2 therapy change frequency as determined by clinical need and cannot be predicted
Primary outcome [2] 323068 0
Change in patients physiology (respiratory)
Respiratory rate as assessed by monitoring clinician
Timepoint [2] 323068 0
For each % FiO2 therapy change - maximum duration of ten days (whilst on AIRVO therapy but expected to be 48Hours based on historical data))
FiO2 therapy change frequency as determined by clinical need and cannot be predicted
Secondary outcome [1] 378843 0
Change in patients physiology (cardiac):
Blood pressure as assessed by bench-top sphygmomanometer and or in line arterial monitor if available
Timepoint [1] 378843 0
For each % FiO2 therapy change - maximum duration of ten days (whilst on AIRVO therapy but expected to be 48Hours based on historical data))
FiO2 therapy change frequency as determined by clinical need and cannot be predicted
Secondary outcome [2] 380686 0
Change in patients physiology (cardiac):
Heart rate as assessed by infrared pulse oximeter
Timepoint [2] 380686 0
For each % FiO2 therapy change - maximum duration of ten days (whilst on AIRVO therapy but expected to be 48Hours based on historical data))
FiO2 therapy change frequency as determined by clinical need and cannot be predicted

Eligibility
Key inclusion criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged > 16 years
4. Ability to tolerate the therapy and be willing to adhere to the study intervention regimen
5. Agreement to adhere to therapy considerations throughout study duration
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in this study:

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 i.e. simultaneously

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)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
1/06/2020
Actual
Date of last participant enrolment
Anticipated
1/10/2020
Actual
Date of last data collection
Anticipated
30/10/2020
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 22232 0
New Zealand
State/province [1] 22232 0
Bay of Plenty

Funding & Sponsors
Funding source category [1] 304704 0
Commercial sector/Industry
Name [1] 304704 0
Fisher & Paykel Healthcare
Country [1] 304704 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare
Address
Fisher & Paykel Healthcare
15 Maurice Paykel Place East Tamaki , Auckland
PO BX 2015 Auckland
Country
New Zealand
Secondary sponsor category [1] 305018 0
None
Name [1] 305018 0
None
Address [1] 305018 0
Country [1] 305018 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 305122 0
NZ HDEC
Ethics committee address [1] 305122 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 305122 0
New Zealand
Date submitted for ethics approval [1] 305122 0
01/05/2020
Approval date [1] 305122 0
Ethics approval number [1] 305122 0

Summary
Brief summary
The intensive monitoring of a patients’ physiological response to therapies such as Nasal High Flow is mandated and is a component of standard care. This physiological response data is used to inform clinical decision making and subsequent titration of a therapy to meet the dynamic and individual needs of a patient. Currently data on patient condition and oxygen delivery, if they are recorded, are recorded on discrete devices, making it difficult to relate them. It is proposed that a single device may record these data to allow analysis of patients’ physiologic response to changing NHF therapy. No such devices are currently available.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99346 0
Dr Troy Browne
Address 99346 0
C/- ICU ,
Bay of Plenty District Area Health Board
829 Cameron Road,
Tauranga South,
Tauranga 3112
Country 99346 0
New Zealand
Phone 99346 0
+64 21 473 419
Fax 99346 0
Email 99346 0
[email protected]
Contact person for public queries
Name 99347 0
Mrs Jane ODonnell
Address 99347 0
Fisher & Paykel Healthcare
15 Maurice Paykel PL
East Tamaki
Auckland
PO Bx 2015 Auckland
Country 99347 0
New Zealand
Phone 99347 0
+64 21563836
Fax 99347 0
Email 99347 0
[email protected]
Contact person for scientific queries
Name 99348 0
Mrs Jane ODonnell
Address 99348 0
Fisher & Paykel Healthcare
15 Maurice Paykel PL
East Tamaki
Auckland
PO Bx 2015 Auckland
Country 99348 0
New Zealand
Phone 99348 0
+64 21563 836
Fax 99348 0
Email 99348 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Vulnerable population


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.