Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000249651
Ethics application status
Approved
Date submitted
9/08/2005
Date registered
31/08/2005
Date last updated
30/12/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of acute oxygen therapy on cognitive and driving performance in hypoxaemic COPD.
Scientific title
Effects of acute oxygen therapy on cognitive and driving performance in hypoxaemic COPD.
Universal Trial Number (UTN)
Trial acronym
DriveOx
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoxaemic COPD 336 0
Condition category
Condition code
Respiratory 388 388 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive function and driving performance on a computerised driving simulator are measured before and after intranasal oxygen at a flow rate known to relieve hypoxaemia. Duration of each intervention is approximately 40 minutes
Intervention code [1] 3879 0
Treatment: Other
Comparator / control treatment
The control arm involves the same tests on the same patients whilst breathing medical air at the same gas flow rate.
Control group
Placebo

Outcomes
Primary outcome [1] 445 0
Driving performance on a computerised driving simulator
Timepoint [1] 445 0
Measured at baseline and after acute exposure to the gas being studied.
Secondary outcome [1] 976 0
Cognitive function assessed using a psychomotor vigilance task (PVT).
Timepoint [1] 976 0
At baseline and after acute exposure to the gas being studied.

Eligibility
Key inclusion criteria
Clinical diagnosis of COPD, demonstrated hypoxaemia at rest on room air (PaO2<60mmHg) and demonstrated adequate reversal of hypoxaemia (to >60mmHg) with supplemental oxygen, current driving licence.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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 envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization performed using published table of random numbers (odd/even) in Statistics at square one. 9th ed., p138 TDV Swinscow BMJ Publishing group, 1996. ISBN 0-7279-0916-9
Masking / blinding
Blinded (masking 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
1/07/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 440 0
Charities/Societies/Foundations
Name [1] 440 0
Victorian Tuberculosis and Lung Association
Country [1] 440 0
Australia
Primary sponsor type
Other
Name
Institute for Breathing and Sleep
Address
Studley Road
Heidelberg VIC 3081
Country
Australia
Secondary sponsor category [1] 358 0
Hospital
Name [1] 358 0
Austin Hospital
Address [1] 358 0
Studley Road
Heidelberg VIC 3081
Country [1] 358 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1413 0
Austin Hospital
Ethics committee address [1] 1413 0
Ethics committee country [1] 1413 0
Australia
Date submitted for ethics approval [1] 1413 0
Approval date [1] 1413 0
Ethics approval number [1] 1413 0

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

Contacts
Principal investigator
Name 35527 0
Address 35527 0
Country 35527 0
Phone 35527 0
Fax 35527 0
Email 35527 0
Contact person for public queries
Name 9340 0
Jeff Pretto
Address 9340 0
Department of Respiratory & Sleep Medicine
John Hunter Hospital
Newcastle NSW
Country 9340 0
Australia
Phone 9340 0
+61 2 49223150
Fax 9340 0
+61 2 49223160
Email 9340 0
[email protected]
Contact person for scientific queries
Name 268 0
Jeff Pretto
Address 268 0
Department of Respiratory & Sleep Medicine
John Hunter Hospital
Newcastle NSW
Country 268 0
Australia
Phone 268 0
+61 2 49223150
Fax 268 0
+61 2 49223160
Email 268 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.