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Trial registered on ANZCTR


Registration number
ACTRN12607000196448
Ethics application status
Approved
Date submitted
3/04/2007
Date registered
5/04/2007
Date last updated
13/03/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Oxygen therapy in pneumonia
Scientific title
A randomised controlled trial of the effect of high flow verus titrated oxygen therapy on carbon dioxide (CO2) levels in pneumonia
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumonia 1718 0
Condition category
Condition code
Respiratory 1810 1810 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomly assigned to receive oxygen regimes for 1 hour: Continuous high flow oxygen (8L/min via Hudson mask) as the intervention.
Intervention code [1] 1656 0
Treatment: Other
Comparator / control treatment
Patients will be randomly assigned to receive variable flow oxygen titrated to achieve an oxygen saturation of 93-95% (via nasal prongs or Hudson mask as required) as the comparator/control.
Control group
Active

Outcomes
Primary outcome [1] 2532 0
Proportion of patients with an increase in partial pressure of arterial carbon dioxide (PaCO2) greater than or equal to 4mmHg
Timepoint [1] 2532 0
At 1 hour
Secondary outcome [1] 4374 0
Proportion of patients with a partial pressure of arterial carbon dioxide (PaCO2) greater than or equal to 38mmHg and an increase of greater than or equal to 4mmHg.
Timepoint [1] 4374 0
At 1 hour
Secondary outcome [2] 4375 0
Change in respiratory rate and heart rate at time 0, 20minutes, 40minutes and 1hour.
Timepoint [2] 4375 0
At time 0, 20minutes, 40minutes and 1hour
Secondary outcome [3] 4376 0
Need for hospital admission at the end of the emergency department treatment period. The end of the emergency department treatment is variable as it depends on the patient and the severity of the condition, and therefore a time can not be specified.
Timepoint [3] 4376 0
The end of the emergency department treatment is variable as it depends on the patient and the severity of the condition, and therefore a time can not be specified.
Secondary outcome [4] 4377 0
Mean change in PaCO2.
Timepoint [4] 4377 0
At time = 1 hour
Secondary outcome [5] 4378 0
Combined primary endpoint with oxygen and asthma study ACTRN012607000131459 measured as the total proportion of patients in the asthma and pneumonia trials with an increase in PaCO2 greater than or equal to 4mmHg at time=1 hour
Timepoint [5] 4378 0
Time = 1 hour

Eligibility
Key inclusion criteria
CoughAt least one systemic feature (sweating, rigors and/or fever >37.8 C)Respiratory rate >18 breaths/min.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Respiratory failure requiring mechanical ventilation; Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)/emphysema; Acute electrocardiogram (ECG) changes suggesting ischaemia; Suspected neutropenic sepsis; Known or suspected chronic hypercapnic respiratory failure as a result of any of the following disorders - neuromuscular disease, chest wall disease, obesity hypoventilation syndrome.

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 that consent and meet the study criteria will be enrolled onto the study and allocated treatment from a secure randomisation list held on computer database and accessed by log-in code
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Third party randomisation will be used with random number sequences generated by a computer programme
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 492 0
New Zealand
State/province [1] 492 0

Funding & Sponsors
Funding source category [1] 1961 0
Government body
Name [1] 1961 0
Capital and Coast District Health Board
Country [1] 1961 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
PO Box 10055
The Terrace
Wellington
Country
New Zealand
Secondary sponsor category [1] 1771 0
Government body
Name [1] 1771 0
Capital and Coast District Health Board
Address [1] 1771 0
Wellington Hospital
Riddiford Street
Newtown
Wellington
Country [1] 1771 0
New Zealand
Secondary sponsor category [2] 1772 0
Government body
Name [2] 1772 0
Health Research Council of New Zealand
Address [2] 1772 0
Level 3, 110 Stanley Street, Auckland, New Zealand
Country [2] 1772 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3657 0
Central Regional Ethics Committee
Ethics committee address [1] 3657 0
Ethics committee country [1] 3657 0
New Zealand
Date submitted for ethics approval [1] 3657 0
Approval date [1] 3657 0
18/01/2007
Ethics approval number [1] 3657 0
CEN/06/11/101

Summary
Brief summary
Current standard treatment is to provide high flow oxygen to people with pneumonia. However high flow oxygen may be detrimental and few studies have looked at the use of high flow oxygen in pneumonia. An alternaitve treatment is one where the amount of oxygen received is varied depending on the oxygen level in the blood. This study compares the two treatments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27759 0
Address 27759 0
Country 27759 0
Phone 27759 0
Fax 27759 0
Email 27759 0
Contact person for public queries
Name 10845 0
Dr Kyle Perrin
Address 10845 0
Medical Research Institute of New Zealand
Level 3
99 The Terrace
Wellington
Country 10845 0
New Zealand
Phone 10845 0
+ 64 4 4729120
Fax 10845 0
Email 10845 0
[email protected]
Contact person for scientific queries
Name 1773 0
Dr Kyle Perrin
Address 1773 0
Medical Research Institute of New Zealand
Level 3
99 The Terrace
Wellington
Country 1773 0
New Zealand
Phone 1773 0
+ 64 4 4729120
Fax 1773 0
Email 1773 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.