Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000528055
Ethics application status
Not yet submitted
Date submitted
25/06/2010
Date registered
30/06/2010
Date last updated
30/06/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of continuous positive airway pressure on lung function in patients with acute exacerbation of heart failure
Scientific title
In patients with acute decompensated heart failure does continuous positive airway pressure compared to oxygen or standard medical therapy result in improved lung function?
Secondary ID [1] 252106 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 257655 0
Condition category
Condition code
Cardiovascular 257831 257831 0 0
Other cardiovascular diseases
Respiratory 257832 257832 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
continuous positive airway pressure via nasal or full face mask at 10cm H2O pressure for 30 minutes from time of randomisation

continuous positive airway therapy via nasal or full face mask at a starting pressure of 4cm H2O increasing by 2cm H2O every 5 minutes for a total of 30 minutes from time of randomisation
Intervention code [1] 256726 0
Treatment: Devices
Comparator / control treatment
standard medical therapy
oxygen via nasal prongs at 2 L/min for 30 minutes
Control group
Active

Outcomes
Primary outcome [1] 258690 0
change in lung reactance as measured by the forced oscillation technique
Timepoint [1] 258690 0
At 5 minute intervals from randomisation for 30 minutes
Primary outcome [2] 258691 0
change in lung compliance as measured by the forced oscillation technique
Timepoint [2] 258691 0
At 5 minute intervals from randomisation for 30 minutes
Secondary outcome [1] 264718 0
change in clinical parameters (oxygen saturation and heart rate from pulse oximeter, respiratory rate via clinical examination, blood pressure via automatic sphygmanometer)
Timepoint [1] 264718 0
At 5 minute intervals from randomisation for 30 minutes
Secondary outcome [2] 264719 0
change in BORG dyspnoea score
Timepoint [2] 264719 0
At 5 minute intervals from randomisation for 30 minutes

Eligibility
Key inclusion criteria
Patients diagnosed with an acute exacerbation of their heart failure
Previous diagnosis of heart failure based on echocardiography
Stable clincial status: respiratory rate <35 bpm, oxygen saturation via pulse oximeter(SpO2) > or equal to 85% on room air, systolic blood pressure > 90mmHg, clinically well perfused and able to speak in sentences
Co-operative and able to give consent
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
History of lung disease requireing treatment > 4 weeks
Severe renal (requiring dialysis) or neurological disease
Recent myocardial infarction (<6 weeks)
Requiring itravenous inotropes

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)
Subjects will be randomised to treatment groups following enrollment into the trial. Subjects will be allocated via cards drawn from an opaque envelope following enrolment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation protocol: Opaque envelopes containing cards labelled "CPAP (fixed)", "CPAP (variable)" or "oxygen" will be used. The labels will be evenly distributed (one third each category). Cards will be drawn from the envelope in a blinded fashion after enrollment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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
1/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3006 0
3181

Funding & Sponsors
Funding source category [1] 257203 0
Charities/Societies/Foundations
Name [1] 257203 0
Royal Australian College of Physicians
Country [1] 257203 0
Australia
Primary sponsor type
Individual
Name
Professor Matthew Naughton
Address
Head, General Rspiratory and Sleep Medicine
Department of Allergy, Immunology and Respiratory Medicine
The Alfred
PO Box 315
Prahran, Vic, 3181
Country
Australia
Secondary sponsor category [1] 256457 0
Individual
Name [1] 256457 0
Dr Kirk Kee
Address [1] 256457 0
Respiratory and Sleep Fellow
Department of Allergy, Immunology and Respiratory Medicine
The Alfred
PO Box 315
Prahran, Vic, 3181
Country [1] 256457 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259231 0
The Alfred Ethics Committee
Ethics committee address [1] 259231 0
The Alfred
PO Box 315
Prahran, Vic, 3181
Ethics committee country [1] 259231 0
Australia
Date submitted for ethics approval [1] 259231 0
21/06/2010
Approval date [1] 259231 0
Ethics approval number [1] 259231 0
Project 193/10

Summary
Brief summary
This study aims to evaluate the changes in lung function caused by the use of continuous positive airway pressure compared to standard therapy in patients who have been diagnosed with a worsening of their heart failure. Continuous positive airway pressure is a way of delivering pressure to the airway through a mask connected to a machine. It is used routinely in the treatment of heart failure to improve outcomes but how it works on the lungs is not well understood. By using a method of measuring lung function that can be done whilst on continuous positive airway pressure and that requires minimal active patient co-operation this trial hopes to provide insight into the mechanisms of this treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31339 0
Address 31339 0
Country 31339 0
Phone 31339 0
Fax 31339 0
Email 31339 0
Contact person for public queries
Name 14586 0
Kirk Kee
Address 14586 0
Respiratory and Sleep Fellow
Department of Allergy, Immunology and Respiratory Medicine
The Alfred
PO Box 315
Prahran, Vic, 3181
Country 14586 0
Australia
Phone 14586 0
+61 3 9076 3770
Fax 14586 0
Email 14586 0
[email protected]
Contact person for scientific queries
Name 5514 0
Kirk Kee
Address 5514 0
Respiratory and Sleep Fellow
Department of Allergy, Immunology and Respiratory Medicine
The Alfred
PO Box 315
Prahran, Vic, 3181
Country 5514 0
Australia
Phone 5514 0
+61 3 9076 3770
Fax 5514 0
Email 5514 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
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Documents added automatically
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