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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12605000037606
Ethics application status
Approved
Date submitted
18/07/2005
Date registered
25/07/2005
Date last updated
25/07/2005
Type of registration
Retrospectively registered
Titles & IDs
Public title
NIVOAD Study: Non Invasive Ventilation in Obstructive Airways Diseases Study
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Scientific title
NIVOAD Study: Non Invasive Ventilation duration in Obstructive Airways Diseases Study
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Airway Disease
100
0
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Chronic Obstructive Pulmonary Disease
101
0
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Asthma
102
0
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Condition category
Condition code
Respiratory
121
121
0
0
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Chronic obstructive pulmonary disease
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Respiratory
122
122
0
0
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
CPAP vs BiPAP The duration is unknown but it is estimated to be in the order of 120 minutes
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Intervention code [1]
29
0
None
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Comparator / control treatment
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Control group
Active
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Outcomes
Primary outcome [1]
152
0
Duration of non invasive ventilation
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Assessment method [1]
152
0
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Timepoint [1]
152
0
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Secondary outcome [1]
335
0
Need for intubation
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Assessment method [1]
335
0
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Timepoint [1]
335
0
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Secondary outcome [2]
336
0
Mask intolerance
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Assessment method [2]
336
0
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Timepoint [2]
336
0
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Secondary outcome [3]
337
0
Need for HDU/ICU, HDU/ICU length of stay
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Assessment method [3]
337
0
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Timepoint [3]
337
0
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Secondary outcome [4]
338
0
Hospital length of stay
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Assessment method [4]
338
0
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Timepoint [4]
338
0
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Eligibility
Key inclusion criteria
All patients presenting to participating EDs with moderate to severe exacerbations of obstructive airways disease and judged by the clinical staff as requiring NIV. Criteria for this judgement include RR >23, SaO2 <90% on room air or <93% on 15 lpm via Hudson mask or an inability to speak in sentences.
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Minimum age
18
Years
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Maximum age
Not stated
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Obtundation (to the point of being unable to cooperate or protect the airway), primary cause of respiratory failure other than asthma or COAD, untreated pneumothorax, endotracheal intubation and a decision to withhold or withdraw treatment made by the clinician in consultation with the patient or next of kin.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
Single Blind: assessors blinded, not participants
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Phase
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/06/2005
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
192
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
166
0
Self funded/Unfunded
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Name [1]
166
0
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Address [1]
166
0
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Country [1]
166
0
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Primary sponsor type
Individual
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Name
Dr Anthony Cross
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Address
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Country
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Secondary sponsor category [1]
121
0
Individual
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Name [1]
121
0
Dr Ogilvie Thom
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Address [1]
121
0
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Country [1]
121
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
912
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Box Hill Hospital
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Ethics committee address [1]
912
0
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Ethics committee country [1]
912
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Australia
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Date submitted for ethics approval [1]
912
0
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Approval date [1]
912
0
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Ethics approval number [1]
912
0
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Ethics committee name [2]
913
0
Maroondah Hospital
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Ethics committee address [2]
913
0
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Ethics committee country [2]
913
0
Australia
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Date submitted for ethics approval [2]
913
0
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Approval date [2]
913
0
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Ethics approval number [2]
913
0
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Ethics committee name [3]
914
0
Angliss Hospital
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Ethics committee address [3]
914
0
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Ethics committee country [3]
914
0
Australia
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Date submitted for ethics approval [3]
914
0
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Approval date [3]
914
0
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Ethics approval number [3]
914
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Summary
Brief summary
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
35752
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Address
35752
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Country
35752
0
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Phone
35752
0
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Fax
35752
0
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Email
35752
0
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Contact person for public queries
Name
9218
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Dr Anthony Cross
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Address
9218
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c/o Emergency Department
Box Hill Hospital
PO Box 94
Box Hill VIC 3128
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Country
9218
0
Australia
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Phone
9218
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+61 3 98953333
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Fax
9218
0
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Email
9218
0
[email protected]
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Contact person for scientific queries
Name
146
0
Dr Anthony Cross
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Address
146
0
c/o Emergency Department
Box Hill Hospital
PO Box 94
Box Hill VIC 3128
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Country
146
0
Australia
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Phone
146
0
+61 3 98953333
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Fax
146
0
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Email
146
0
[email protected]
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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.
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