Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000719639
Ethics application status
Approved
Date submitted
31/10/2005
Date registered
8/11/2005
Date last updated
14/01/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of high flow nasal oxygen to high flow face mask oxygen in recently extubated patients.
Scientific title
A randomised crossover trial comparing the efficacy of the Fisher & Paykel Healthcare High Flow Nasal Interface (HFNO) to Hudson Face Mask (FMO) in maintaining PaO2 saturations in recently extubated patients requiring supplemental oxygen to treat hypoxia.
Secondary ID [1] 219 0
Clinical Study number 2005-16
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoxia 869 0
Condition category
Condition code
Respiratory 936 936 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During a 30 minute washout period post-extubation, patients will be titrated to receive a fraction of oxygen (FiO2) at a flow rate of 30 lpm. At the end of this period an arterial blood gas sample will be taken. Patients will then be randomised to receive either FMO or HFNO. The FiO2 and flow rate will remain the same. At the end of 30 minutes an ABG will be taken. Patients will then crossover to receive the other mode for 30 minutes with an ABG taken at the end of the period.
The FMO group will have oxygen supplied via a Hudson Face Mask and a Fisher & Paykel Healthcare MR850 humidifier. The HFNO group will have oxygen supplied via a Fisher & Paykel Healthcare MR880 humidification system.
Intervention code [1] 743 0
Treatment: Devices
Comparator / control treatment
Standard oxygen therapy with Hudson face mask. A Hudson face mask is a simple oxygen mask. (The high flow nasal interface in a wide bore nasal cannula)
Control group
Active

Outcomes
Primary outcome [1] 1231 0
Arterial blood gas
Timepoint [1] 1231 0
Samples will be taken at 30 minutes after each time treatment has been given.
Secondary outcome [1] 2243 0
Endpoints include heart rate, blood pressure, respiratory rate, ability to tolerate mode (nurse assessed).
Timepoint [1] 2243 0
Secondary endpoints will be measured at the same time points as ABG sampling is performed.
Secondary outcome [2] 2244 0
Patient reported comfort will be obtained once the patient is able to talk clearly.
Timepoint [2] 2244 0
When patients are able to talk clearly

Eligibility
Key inclusion criteria
Patients meeting extubation criteria whose families provide consent and later give delayed consent.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who do not consent; patients with DNR order.

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 blocking also used
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/07/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1036 0
Commercial sector/Industry
Name [1] 1036 0
Fisher and Paykel Healthcare
Country [1] 1036 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
15 Maurice Paykel Place. East Tamaki. Auckland 2013
Country
New Zealand
Secondary sponsor category [1] 898 0
None
Name [1] 898 0
none
Address [1] 898 0
Country [1] 898 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2335 0
Peninsula Health,
Ethics committee address [1] 2335 0
Ethics committee country [1] 2335 0
Australia
Date submitted for ethics approval [1] 2335 0
Approval date [1] 2335 0
Ethics approval number [1] 2335 0
Ethics committee name [2] 2336 0
Frankston Intensive Care Unit
Ethics committee address [2] 2336 0
Ethics committee country [2] 2336 0
Australia
Date submitted for ethics approval [2] 2336 0
Approval date [2] 2336 0
Ethics approval number [2] 2336 0

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

Contacts
Principal investigator
Name 35373 0
Address 35373 0
Country 35373 0
Phone 35373 0
Fax 35373 0
Email 35373 0
Contact person for public queries
Name 9932 0
Catherine Gerard
Address 9932 0
15 Maurice Paykel Place
East Tamaki Auckland
Country 9932 0
New Zealand
Phone 9932 0
+64 9 5740100
Fax 9932 0
Email 9932 0
[email protected]
Contact person for scientific queries
Name 860 0
Dr Nina Fowler
Address 860 0
Intensive Care Unit
Frankston Hospital
PO Box 52
Frankston VIC 3199
Country 860 0
Australia
Phone 860 0
+61 3 97848567
Fax 860 0
Email 860 0
[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.