Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000139572
Ethics application status
Approved
Date submitted
18/04/2006
Date registered
24/04/2006
Date last updated
14/01/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
The High Flow Oxygen Therapy Study
Scientific title
A pilot study to validate the use of high flow humidified oxygen therapy in a Cardiothoracic and Vascular Intensive Care Unit (CVICU), in patients requiring supplemental oxygen to treat hypoxia as assessed by arterial blood gas (PaO2).
Universal Trial Number (UTN)
Trial acronym
The HOT Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoxia. 1108 0
Condition category
Condition code
Blood 1188 1188 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients meeting the inclusion criteria will be randomised to receive oxygen via a high flow humidified nasal interface. Once randomised, patients will remain on that mode of delivery until they are weaned/discontinued. Patients will be set to a target SpO2 of 95% and data from the patients' clinical charts recording arterial blood gas measurements, heart rate and respiratory rate will be taken at standard time points.
Patient length of ICU stay from point of randomisation will be recorded.
Intervention code [1] 986 0
Treatment: Devices
Comparator / control treatment
Patients meeting the inclusion criteria will be randomised to receive oxygen either via a face mask as per standard care.
Control group
Active

Outcomes
Primary outcome [1] 1602 0
Arterial blood gas (PaO2 and PaCO2)
Timepoint [1] 1602 0
Recorded at baseline, 30 minutes post-randomisation, 1 hour post, 2 hour post and 4 hours post. After that arterial blood gas will be recorded as per hospital protocol.
Secondary outcome [1] 2900 0
Secondary outcomes include heart rate, blood pressure and respiratory rate.
Timepoint [1] 2900 0
Measured continuously whilst in the ICU/HDU.
Secondary outcome [2] 2901 0
Airway pressures whilst wearing the high flow humidified nasal interface will be measured via a hypopharyngeal catheter, in a subset of patients (n=15).
Timepoint [2] 2901 0
This will be recorded as soon as is practically possible once the patient is comfortable. It is anticipated this will be in the first 24 hours post randomisation for the majority of patients.

Eligibility
Key inclusion criteria
Consent has been obtained or is likely to be obtained- Patient currently on oxygen therapy via nasal prongs or mask- In the opinion of the treating clinical team the patient has sub optimal gas exchange and/or the patient is in a degree of mild respiratory distress.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The patient is likely to require imminent intubation (within 30mins)- The patient has a tracheostomy in situ- Patient would not be offered mechanical/non invasive ventilation due to clinical condition/prognosis- The patient has previously been enrolled in this study- The patient has already been treated with high flow nasal oxygen in the CVICU or Ward 42 this admission- Contraindication to high flow nasal oxygen.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generation with a non variable block size.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 301 0
New Zealand
State/province [1] 301 0

Funding & Sponsors
Funding source category [1] 1299 0
Commercial sector/Industry
Name [1] 1299 0
Fisher and Paykel Healthcare
Country [1] 1299 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
15 Maurice Paykel Place. East Tamaki. Auckland 2013 . New Zealand
Country
New Zealand
Secondary sponsor category [1] 1147 0
None
Name [1] 1147 0
n/a
Address [1] 1147 0
Country [1] 1147 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2628 0
Auckland Hospital
Ethics committee address [1] 2628 0
Ethics committee country [1] 2628 0
Date submitted for ethics approval [1] 2628 0
Approval date [1] 2628 0
Ethics approval number [1] 2628 0
NTX/06/04/037

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

Contacts
Principal investigator
Name 35604 0
Address 35604 0
Country 35604 0
Phone 35604 0
Fax 35604 0
Email 35604 0
Contact person for public queries
Name 10175 0
Catherine Gerard
Address 10175 0
15 Maurice Paykel Place,
East Tamaki,
Auckland.
Country 10175 0
New Zealand
Phone 10175 0
+64-9-5740100
Fax 10175 0
Email 10175 0
catherine.gerard@fphcare.co.nz
Contact person for scientific queries
Name 1103 0
Dr Shay McGuinness
Address 1103 0
Cardiothoracic and Vascular Intensive Care Unit,
Auckland City Hospital
Private Bag 92024
Auckland
Country 1103 0
New Zealand
Phone 1103 0
+64-9-3074949 ext 24471
Fax 1103 0
Email 1103 0
shaymc@adhb.govt.nz

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.