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Trial registered on ANZCTR


Registration number
ACTRN12605000759695
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
21/11/2005
Date last updated
7/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Humidification for home non-invasive ventilation
Scientific title
Humidification and non-invasive ventilation in patients with chronic respiratory failure: impact on patient's tolerance and pattern of use
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stable hypercapnic patients affected by either COPD, neuromuscular disorders or restrictive thoracic disease 915 0
Condition category
Condition code
Respiratory 982 982 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients prescribed to receive noninvasive ventilation in the home will receive humidification delivered at 31 degrees and 32 mg H2O/L.

They will receive this humidification therapy for 6 months, then swap over to the other therapy for 6 months.
Intervention code [1] 440 0
None
Comparator / control treatment
Patients prescribed to receive noninvasive ventilation in the home will receive no humidification added.

They will receive this humidification therapy for 6 months, then the other therapy for 6 months.
Control group
Active

Outcomes
Primary outcome [1] 1304 0
Compliance to nocturnal noninvasive ventilation assessed subjectively by a tolerance score and objectively by hours of noninvasive ventilation actually delivered to the patient.
Timepoint [1] 1304 0
Measured every 3 months.
Secondary outcome [1] 2333 0
Side-effects associated with chronic use of noninvasive ventilation.
Timepoint [1] 2333 0
This is measured every 3 months.
Secondary outcome [2] 2334 0
Rate of upper and lower airway infections.
Timepoint [2] 2334 0
This is measured every 3 months.
Secondary outcome [3] 2335 0
Incidence of colonization of the circuitry.
Timepoint [3] 2335 0
This is measured every 3 months.
Secondary outcome [4] 2336 0
Rate of improvement of ABG.
Timepoint [4] 2336 0
This is measured every 3 months.

Eligibility
Key inclusion criteria
Need for long term noninvasive mechanical ventilation.Informed consent. pH > 7.35 and PaCO2 > 50 mmHg (while breathing room air).
Minimum age
Not stated
Maximum age
80 Years
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)
Computer sequence (Statistica package. No stratification block)
Masking / blinding
Open (masking not 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
6/10/2003
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] 197 0
New Zealand
State/province [1] 197 0

Funding & Sponsors
Funding source category [1] 1079 0
Commercial sector/Industry
Name [1] 1079 0
Fisher & Paykel Heathcare
Country [1] 1079 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Heathcare
Address
15, Maurice Paykel Place, East Tamaki, Auckland
Country
New Zealand
Secondary sponsor category [1] 940 0
None
Name [1] 940 0
N/A
Address [1] 940 0
Country [1] 940 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36403 0
Address 36403 0
Country 36403 0
Phone 36403 0
Fax 36403 0
Email 36403 0
Contact person for public queries
Name 9629 0
Professor Stefano Nava
Address 9629 0
Respiratory Intensive Care Unit
Fondazione Salvatore Maugeri
Pavia
Country 9629 0
Italy
Phone 9629 0
+39 3825921
Fax 9629 0
+39 382592302
Email 9629 0
snava@fsm.it
Contact person for scientific queries
Name 557 0
Ms Emma Duckworth
Address 557 0
Fisher & Paykel Healthcare Ltd
PO Box 14 348
Panmure Auckland 6
Country 557 0
New Zealand
Phone 557 0
+64 9 5740100
Fax 557 0
+64 9 5740155
Email 557 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.