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Trial registered on ANZCTR


Registration number
ACTRN12610000556044
Ethics application status
Not yet submitted
Date submitted
25/06/2010
Date registered
9/07/2010
Date last updated
9/07/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of Posture and Continuous Positive Airway Pressure (CPAP) on lung function in patients recovering from an acute exacerbation of heart failure
Scientific title
In patients who have been admitted with worsening of their heart failure, does continuous positive airway pressure compared to oxygen result in an improvement in lung function?
Secondary ID [1] 252102 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 257656 0
Condition category
Condition code
Cardiovascular 257833 257833 0 0
Other cardiovascular diseases
Respiratory 257834 257834 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
10 minutes of continuous positive airway pressure at 10cm H2O pressure via nasal or full face mask in the sitting position

Followed by

10 minutes of continuous positive airway pressure at 10cm H2O pressure via nasal or full face mask in the supine position
Intervention code [1] 256727 0
Treatment: Devices
Comparator / control treatment
10 minutes of oxygen at 2 lpm via nasal prongs in the sitting position

Followed by

10 minutes of oxygen at 2 lpm via nasal prongs in the supine position
Control group
Active

Outcomes
Primary outcome [1] 258692 0
Lung reactance and compliance as measured by the forced oscillation technique
Timepoint [1] 258692 0
Daily during admission from time of randomisation and on day 30 post discharge.
Primary outcome [2] 258694 0
Change in respiratory function tests (as a composite end point) including: forced expiratory time and vital capacity via spirometry, static lung volumes via body plethysmography and inert gas washout, gas transfer via the diffusing capacity of the lung for carbon monoxide (DLCO) method and respiratory muscle strength via maximal inspiratory and expiratory mouth pressures.
Timepoint [2] 258694 0
At days 2-4 of admission and then on discharge and on day 30 post discharge.
Primary outcome [3] 258697 0
Lung heterogeneity via the nitrogen multi-breath washout technique
Timepoint [3] 258697 0
At days 2-4 of admission and then on discharge and on day 30 post discharge.
Secondary outcome [1] 264720 0
Change in clinical parameters (oxygen saturation and heart rate via pulse oximetry, respiratory rate clinically, blood pressure via automatic sphygmomanometer)
Timepoint [1] 264720 0
Daily during admission from time of randomisation and on day 30 post discharge.
Secondary outcome [2] 264721 0
change in BORG dyspnoea score
Timepoint [2] 264721 0
Daily during admission from time of randomisation and on day 30 post discharge.

Eligibility
Key inclusion criteria
Patients admitted to The Alfred with the diagnosis of an exacerbation of cardiac failure
Previous diagnosis of heart failure based on echocardiography
Stable clinical status: Respiratory Rate<35, oxygen saturation via pulse oximetry (SpO2) > 84% on room air, systolic blood pressure >90mmHg, clinically well perfused and able to talk sentences
Co-operative, 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 chronic lung disease requiring long term (>4 weeks) treatment
Severe renal (requiring dialysis) or neurological disease
Recent myocardial infarction (< 6 weeks)
Require intravenous 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 enrolled into trial on day of admission. Randomisation will occur following enrollment and subjects allocated from an opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will involve drawing labelled cards from an opaque envelope. half the cards will be labelled CPAP and the other half will be labelled oxygen.
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
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257205 0
Charities/Societies/Foundations
Name [1] 257205 0
Royal Australian College of Physicians
Country [1] 257205 0
Australia
Primary sponsor type
Individual
Name
Professor Matthew Naughton
Address
Head, General Respiratory and Sleep Medicine
Department of Allergy, Immunology and Respiratory Medicine
The Alfred
PO Box 315
Prahran, Vic, 3181
Country
Australia
Secondary sponsor category [1] 256459 0
Individual
Name [1] 256459 0
Dr Kirk Kee
Address [1] 256459 0
Respiratory and Sleep Fellow
Department of Allergy, Immunology and Respiratory Medicine
The Alfred
PO Box 315
Prahran, Vic, 3181
Country [1] 256459 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259233 0
The Alfred Ethics Committee
Ethics committee address [1] 259233 0
The Alfred
PO Box 315
Prahran, Vic, 3181
Ethics committee country [1] 259233 0
Australia
Date submitted for ethics approval [1] 259233 0
21/06/2010
Approval date [1] 259233 0
Ethics approval number [1] 259233 0
1/10/0193

Summary
Brief summary
This study aims to evaluate the effects of CPAP compared to oxygen on lung function in subjects as they recover from an episode of worsening heart failure. Subjects will be recruited on admission and have serial testing of their lung function early in their admission, just prior to discharge and 30 days following discharge. The effects of posture on lung function will also be evaluated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31340 0
Address 31340 0
Country 31340 0
Phone 31340 0
Fax 31340 0
Email 31340 0
Contact person for public queries
Name 14587 0
Kirk Kee
Address 14587 0
Respiratory and Sleep Fellow
Department of Allergy, Immunology and Respiratory Medicine
The Alfred
PO Box 315
Prahran, Vic, 3181
Country 14587 0
Australia
Phone 14587 0
+61 3 9076 3770
Fax 14587 0
Email 14587 0
[email protected]
Contact person for scientific queries
Name 5515 0
Kirk Kee
Address 5515 0
Respiratory and Sleep Fellow
Department of Allergy, Immunology and Respiratory Medicine
The Alfred
PO Box 315
Prahran, Vic, 3181
Country 5515 0
Australia
Phone 5515 0
+61 3 9076 3770
Fax 5515 0
Email 5515 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
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