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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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

Study type
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

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.

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
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
Address [1] 1299 0
15 Maurice Paykel Place. East Tamaki. Auckland. New Zealand
Country [1] 1299 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Fisher and Paykel Healthcare
15 Maurice Paykel Place. East Tamaki. Auckland 2013 . New Zealand
New Zealand
Secondary sponsor category [1] 1147 0
Name [1] 1147 0
Address [1] 1147 0
Country [1] 1147 0

Ethics approval
Ethics application status
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

Brief summary
Nasal prong oxygen therapy has several advantages over face mask oxygen such as: improved comfort and the ability to eat and talk while wearing the device. Warming and humidifying inspired gases means that high gas flows are able to be used. High gas flows delivered to the nose may mean that oxygen delivery is more efficient, however this has not been shown in cardiothoracic patients.
We intend to assess whether this new system means that patients are able to be transferred to the ward more quickly.
Trial website
Trial related presentations / publications
Public notes

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,
Country 10175 0
New Zealand
Phone 10175 0
Fax 10175 0
Email 10175 0
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
Country 1103 0
New Zealand
Phone 1103 0
+64-9-3074949 ext 24471
Fax 1103 0
Email 1103 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary