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
Scientific title
NIVOAD Study: Non Invasive Ventilation duration in Obstructive Airways Diseases Study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Airway Disease
 100 0
Chronic Obstructive Pulmonary Disease 101 0
Asthma 102 0
Condition category
Condition code
Respiratory 121 121 0 0
Chronic obstructive pulmonary disease
Respiratory 122 122 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CPAP vs BiPAP The duration is unknown but it is estimated to be in the order of 120 minutes
Intervention code [1] 29 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 152 0
Duration of non invasive ventilation
Timepoint [1] 152 0
Secondary outcome [1] 335 0
Need for intubation
Timepoint [1] 335 0
Secondary outcome [2] 336 0
Mask intolerance
Timepoint [2] 336 0
Secondary outcome [3] 337 0
Need for HDU/ICU, HDU/ICU length of stay
Timepoint [3] 337 0
Secondary outcome [4] 338 0
Hospital length of stay
Timepoint [4] 338 0

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.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
Numbered envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Single Blind: assessors blinded, not participants
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
192
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 166 0
Self funded/Unfunded
Name [1] 166 0
Country [1] 166 0
Primary sponsor type
Individual
Name
Dr Anthony Cross
Address
Country
Secondary sponsor category [1] 121 0
Individual
Name [1] 121 0
Dr Ogilvie Thom
Address [1] 121 0
Country [1] 121 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 912 0
Box Hill Hospital
Ethics committee address [1] 912 0
Ethics committee country [1] 912 0
Australia
Date submitted for ethics approval [1] 912 0
Approval date [1] 912 0
Ethics approval number [1] 912 0
Ethics committee name [2] 913 0
Maroondah Hospital
Ethics committee address [2] 913 0
Ethics committee country [2] 913 0
Australia
Date submitted for ethics approval [2] 913 0
Approval date [2] 913 0
Ethics approval number [2] 913 0
Ethics committee name [3] 914 0
Angliss Hospital
Ethics committee address [3] 914 0
Ethics committee country [3] 914 0
Australia
Date submitted for ethics approval [3] 914 0
Approval date [3] 914 0
Ethics approval number [3] 914 0

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

Contacts
Principal investigator
Name 35752 0
Address 35752 0
Country 35752 0
Phone 35752 0
Fax 35752 0
Email 35752 0
Contact person for public queries
Name 9218 0
Dr Anthony Cross
Address 9218 0
c/o Emergency Department
Box Hill Hospital
PO Box 94
Box Hill VIC 3128
Country 9218 0
Australia
Phone 9218 0
+61 3 98953333
Fax 9218 0
Email 9218 0
anthony.cross@boxhill.org.au
Contact person for scientific queries
Name 146 0
Dr Anthony Cross
Address 146 0
c/o Emergency Department
Box Hill Hospital
PO Box 94
Box Hill VIC 3128
Country 146 0
Australia
Phone 146 0
+61 3 98953333
Fax 146 0
Email 146 0
anthony.cross@boxhill.org.au

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.