Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000404628
Ethics application status
Approved
Date submitted
8/09/2005
Date registered
14/09/2005
Date last updated
8/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Humidification of Noninvasively Ventilated Patients
Scientific title
Is comfort improved in noninvasively ventilated patients receiving heated humidification?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute respiratory failure being treated with Noninvasive ventilation 510 0
Condition category
Condition code
Respiratory 588 588 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Humidification delivered at 31 degrees and 32 mg H2O/L

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] 415 0
None
Comparator / control treatment
No humidification added
Control group
Active

Outcomes
Primary outcome [1] 683 0
Patient perceived comfort as measured by Patient/Nurse Questionnaire
Timepoint [1] 683 0
Questionnaire every hour for the first 6 hours, at 8 hours and every 4 hours after that.
Primary outcome [2] 684 0
Patient compliance as measured by time spent on therapy
Timepoint [2] 684 0
Information stored automatically by the ventilator, download info at any time. Maintain for as long as the therapy is necessary for the patient.
Secondary outcome [1] 1396 0
Failure success rates
Timepoint [1] 1396 0
Wheneve the patient has completed the therapy.
Secondary outcome [2] 1397 0
ICU/HDU length of stay
Timepoint [2] 1397 0
Dates and times of admission and discharge to and from the ICU recorded as they occur.
Secondary outcome [3] 1398 0
Need for mechanical ventilation during or after the study period
Timepoint [3] 1398 0
Recorded during ICU/HDU stay and updated 6 months later
Secondary outcome [4] 1399 0
Physiological variables
Timepoint [4] 1399 0
Ongoing recording of variables as part of normal HDU/ICU procedures
Secondary outcome [5] 1400 0
Therapy interventions.
Timepoint [5] 1400 0
Ongoing recording of additional drug therapies as part of normal HDU/ICU procedures

Eligibility
Key inclusion criteria
Receiving bi-level or CPAP. noninvasive ventilation.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have a tracheostomy.Have had recent oral, esophogeal or gastric surgery.Those patients with poor short term prognosis who are unlikely to be able to complete the 24 hour period.Those patients whose inclusion in the study may constitute an unreasonable intrusion.Cannot competently speak English or answer questions.Have a contraindication to noninvasive ventilation.Prescribed intermittent noninvasive therapy.

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)
Random numbers concealed in opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number table generated on Microsoft Excel. Patients will be randomised in blocks to ensure even distribution of sample size between the two study arms.
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
Completed
Date of first participant enrolment
Anticipated
14/07/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 187 0
New Zealand
State/province [1] 187 0

Funding & Sponsors
Funding source category [1] 642 0
Commercial sector/Industry
Name [1] 642 0
Fisher & Paykel Healthcare
Country [1] 642 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare
Address
15, Maurice Paykel Place, East Tamaki, Auckland
Country
New Zealand
Secondary sponsor category [1] 539 0
None
Name [1] 539 0
N/A
Address [1] 539 0
Country [1] 539 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36025 0
Address 36025 0
Country 36025 0
Phone 36025 0
Fax 36025 0
Email 36025 0
Contact person for public queries
Name 9604 0
Mrs Mary La Pine
Address 9604 0
Intensive Care Unit
Waikato Hospital
Pembroke St
Hamilton
Country 9604 0
New Zealand
Phone 9604 0
+64 7 8398899 (Ext. 8420)
Fax 9604 0
Email 9604 0
LapineM@waikatodhb.govt.nz
Contact person for scientific queries
Name 532 0
Emma Duckworth
Address 532 0
Fisher & Paykel Healthcare
PO Box 14 348
Panmure Auckland
Country 532 0
New Zealand
Phone 532 0
+64 9 5740123 (Ext. 8754)
Fax 532 0
Email 532 0
emma.duckworth@fphcare.co.nz

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.