Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000466640
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
23/09/2005
Date last updated
7/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Humidification of Noninvasively Ventilated Patients
Scientific title
Humidification of patients on noninvasive bi-level ventilation (NIV): Effects on levels of patient agitation and compliance
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute respiratory failure being treated with NIV 585 0
Condition category
Condition code
Respiratory 657 657 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients prescribed to receive noninvasive ventilation will be randomized to receive either:

Humidification delivered at 31°C and 32 mg H2O/L
or
No humidification added

They will receive this therapy for as long as noninvasive ventilation is given to them. Study data will be collected for a maximum of 24 hours.
Intervention code [1] 435 0
None
Comparator / control treatment
No humidification added
Control group
Active

Outcomes
Primary outcome [1] 782 0
Patient agitation levels as measured every hour by the Riker Agitation index.
Timepoint [1] 782 0
Measured every hour
Secondary outcome [1] 1588 0
Patient perceived comfort.
Timepoint [1] 1588 0
Nurse will conduct a questionnaire every hour for the first 6 hours, at 8 hours and every 4 hours of the study period after that.
Secondary outcome [2] 1589 0
Therapy outcomes
Timepoint [2] 1589 0
Nurse will conduct a questionnaire every hour for the first 6 hours, at 8 hours and every 4 hours of the study period after that.
Secondary outcome [3] 1590 0
Failure/success rate of NIV
Timepoint [3] 1590 0
Nurse will conduct a questionnaire every hour for the first 6 hours, at 8 hours and every 4 hours of the study period after that.
Secondary outcome [4] 1591 0
ICU length of stay
Timepoint [4] 1591 0
Nurse will conduct a questionnaire every hour for the first 6 hours, at 8 hours and every 4 hours of the study period after that.
Secondary outcome [5] 1592 0
Need for mechanical ventilation during or after the study period.
Timepoint [5] 1592 0
Nurse will conduct a questionnaire every hour for the first 6 hours, at 8 hours and every 4 hours of the study period after that.

Eligibility
Key inclusion criteria
Receiving bi-level ventilation for more than 60 minutes.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Are or have been weaned from mechanical ventilation.Suffer dementia.Have a tracheostomy.Have had recent oral, esophogeal or gastric surgery.Have a contraindication to NIV.

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)
opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random numbers generated by Microsoft excel. Randomisation will occur in blocks, to ensure even distribution of sample size between the two groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
4/07/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 195 0
New Zealand
State/province [1] 195 0

Funding & Sponsors
Funding source category [1] 726 0
Commercial sector/Industry
Name [1] 726 0
Fisher & Paykel Healthcare
Country [1] 726 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare
Address
15, Maurice Paykel Place, East Tamaki, Auckland, New Zealand
Country
New Zealand
Secondary sponsor category [1] 602 0
None
Name [1] 602 0
n/a
Address [1] 602 0
Country [1] 602 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1925 0
Western Hospital ICU
Ethics committee address [1] 1925 0
Ethics committee country [1] 1925 0
Australia
Date submitted for ethics approval [1] 1925 0
Approval date [1] 1925 0
Ethics approval number [1] 1925 0

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

Contacts
Principal investigator
Name 35168 0
Address 35168 0
Country 35168 0
Phone 35168 0
Fax 35168 0
Email 35168 0
Contact person for public queries
Name 9624 0
Mrs Lorraine Little
Address 9624 0
Intensive Care Unit
Western Hospital
Gordon St
Footscray VIC 3011
Country 9624 0
Australia
Phone 9624 0
+61 3 83456666
Fax 9624 0
+61 3 93185349
Email 9624 0
[email protected]
Contact person for scientific queries
Name 552 0
Ms Emma Duckworth
Address 552 0
Fisher & Paykel Healthcare Ltd
PO Box 14 348
Panmure Auckland 6
Country 552 0
New Zealand
Phone 552 0
+64 9 5740100
Fax 552 0
+64 9 5740155
Email 552 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.