Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000372482
Ethics application status
Approved
Date submitted
9/07/2007
Date registered
16/07/2007
Date last updated
21/12/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study into High Flow Humidified Nasal Oxygen Therapy (OptiflowTM) and its' Impact on Lung Pressures.
Scientific title
A Study of Cardiac Surgical Patients Using High Flow Humidified Nasal Oxygen Therapy (OptiflowTM) and its' Impact on Mean Airway Pressures at Different Flow Rates.
Secondary ID [1] 279640 0
The flow and pressure study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Respiratory Failure 1952 0
Condition category
Condition code
Respiratory 2047 2047 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Whilst participants (n15) are still sedated following cardiac surgery, a 10F pressure catheter will be inserted into the hypopharynx via the nose. Once awake and extubated, participants will be commenced on the OptiflowTM system. Once settled on the therapy the pressure catheter position will be confirmed using end tidal CO2 monitoring. Pressure measurements will then be carried out with three different gas flow rates:30, 40 and 50L/min with mouth open and then repeated with mouth closed. The pressure catheter will be gently removed at the end of this period. The measurements will take approximately 30mins to complete. The intervention is OptiflowTM at three different flow rates. We are investigating only the relationship between flow and pressure. We hope to describe a positive and linear relationship between flow and pressure. ie more flow equals more pressure.
Intervention code [1] 1880 0
Treatment: Devices
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2876 0
Mean airway pressure as determined by measurements taken over one minute of breathing. Specially designed software will be used to carry out the measurements and calculate the mean.
Timepoint [1] 2876 0
Measurement is continuous over one minute. Mean is calculated by averaging the peak and trough pressures over the entire minute of breathing.
Secondary outcome [1] 8905 0
NA
Timepoint [1] 8905 0
NA

Eligibility
Key inclusion criteria
Consent has been obtained • The patient is undergoing cardiac surgery requiring sternotomy.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study if one or more of the following criteria are present:• The patient has significant nasal septum deviation.• High flow nasal oxygen therapy is contraindicated. • Following surgery the patient is unable to follow simple commands once awake and extubated

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is a descriptive study only and is therefore not randomised or blinded.
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 525 0
New Zealand
State/province [1] 525 0
North Island

Funding & Sponsors
Funding source category [1] 2190 0
Commercial sector/Industry
Name [1] 2190 0
Fisher and Paykel Healthcare Ltd
Country [1] 2190 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare Ltd
Address
15 Maurice Paykel Place, East Tamaki, Auckland 2013, New Zealand
Country
New Zealand
Secondary sponsor category [1] 1976 0
Government body
Name [1] 1976 0
Auckland District Health Board
Address [1] 1976 0
Cardiothoracic and Vascular Intensive Care Unit. Level 4. Auckland City Hospital. Park Road. Grafton. Auckland. New Zealand
Country [1] 1976 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3990 0
Northern X New Zealand ethics committee
Ethics committee address [1] 3990 0
Ethics committee country [1] 3990 0
New Zealand
Date submitted for ethics approval [1] 3990 0
Approval date [1] 3990 0
Ethics approval number [1] 3990 0
Ethics committee name [2] 6361 0
Northern X New Zealand ethics committee
Ethics committee address [2] 6361 0
Ministry of Health. 3rd floor. Unisys Building. 650 Great South Road. Penrose. Auckland.
Ethics committee country [2] 6361 0
New Zealand
Date submitted for ethics approval [2] 6361 0
22/08/2007
Approval date [2] 6361 0
30/08/2007
Ethics approval number [2] 6361 0
NTX/07/08/085

Summary
Brief summary
This study will describe the relationship between the flow of gas delivered by the OptiflowTM system and the pressure exerted in the upper airways of 15 cardiac surgical patients. The researchers wish to demonstrate that more gas flow will deliver higher pressures to the airways.This information is needed so that doctors can be guided as to how much flow to administer to patients in order to achieve a desired airway pressure. Such pressure in the airways can assist patients who have breating difficulties. This data will also inform future, more detailed research in this area.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27694 0
Address 27694 0
Country 27694 0
Phone 27694 0
Fax 27694 0
Email 27694 0
Contact person for public queries
Name 11069 0
Rachael Parke
Address 11069 0
Cardiothoracic and Vascular Intensive Care Unit
Level 4
Auckland City Hospital
Park Road
Grafton
Auckland
Country 11069 0
New Zealand
Phone 11069 0
+64 9 3074949 ext. 24489
Fax 11069 0
+64 9 6236463 ext. 24473
Email 11069 0
[email protected]
Contact person for scientific queries
Name 1997 0
Michelle Eccleston
Address 1997 0
Fisher and Paykel Healthcare Ltd
15 Maurice Paykel Place
East Tamaki
Auckland
Country 1997 0
New Zealand
Phone 1997 0
+64 9 5740123 ext. 8671
Fax 1997 0
+64 9 5740158
Email 1997 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.