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Trial registered on ANZCTR


Trial ID
ACTRN12605000263695
Ethics application status
Approved
Date submitted
30/08/2005
Date registered
2/09/2005
Date last updated
20/11/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Humidification for Children with Tracheostomies Study
Scientific title
Humidification for Children with Tracheostomies Study: A cross-over trial comparing a heated humidifier to a heat and moisture exchanger.
Secondary ID [1] 128 0
Auckland Ethics Committee: AKX/04/223
Universal Trial Number (UTN)
Trial acronym
HCT study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children with long term tracheostomies 350 0
Condition category
Condition code
Surgery 407 407 0 0
Other surgery
Respiratory 408 408 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive 3 months of each humidification device. One provides humidification from a heated humidifier set to deliver conditioned air at 37C and 100% relative humidity overnight, with the heat and moisture exchanger used during the day. This will be compared to humidification using a heat and moisture exchanger (Portex Thermovent T) day and night for 3 months.
Intervention code [1] 299 0
None
Comparator / control treatment
The trial compares two different methods of humidification, heated humidifier compared with a heat and moisture exchanger. Participants will be randomised to receive 3 months of humidification via each of these methods in a cross-over manner. No washout period is provided between treatment methods due to the requirement for humidification in patients with tracheostomy
Control group
Active

Outcomes
Primary outcome [1] 468 0
Major clinical events such as admission to hospital, episodes of pneumonia, tracheostomy tube blockages and treatment failures over 3 months
Timepoint [1] 468 0
At the end of each 3 month period
Primary outcome [2] 469 0
Mucociliary clearance measured by radioaerosol technique
Timepoint [2] 469 0
At the end of each 3 months
Secondary outcome [1] 1009 0
The health related quality of life of the child
Timepoint [1] 1009 0
At the end of each 3 month treatment period
Secondary outcome [2] 1010 0
The health related quality of the caregiver
Timepoint [2] 1010 0
At the end of each 3 month treatment period
Secondary outcome [3] 1011 0
Mucus visocelasticity
Timepoint [3] 1011 0
At the end of each 3 month treatment period
Secondary outcome [4] 1012 0
Ciliary beat frequency (CBF)
Timepoint [4] 1012 0
At the end of each 3 month treatment period
Secondary outcome [5] 1013 0
The level of inflammatory markers in airway secretions (IL-8, TNF-α, neutrophil elastase).
Timepoint [5] 1013 0
At the end of each 3 month treatment period
Secondary outcome [6] 1014 0
The incidence of individual clinical outcomes: admissions to hospital, episodes of lower respiratory tract infection, courses of oral antibiotics, episodes of tracheostomy tube blockage, treatment failures.
Timepoint [6] 1014 0
At the end of each 3 month treatment period
Secondary outcome [7] 1015 0
Total numbers of Swedish noses used
Timepoint [7] 1015 0
At the end of each 3 month treatment period
Secondary outcome [8] 1016 0
Total cost of humidification equipment
Timepoint [8] 1016 0
At the end of each 3 month treatment period
Secondary outcome [9] 1017 0
Findings on endobronchial biopsy: numbers of inflammatory cells, degree of metaplasia, and percent ciliation.
Timepoint [9] 1017 0
At the end of each 3 month treatment period

Eligibility
Key inclusion criteria
Tracheostomy in situ for at least 3 months, Age greater than 6 months, Tracheostomy scheduled to be in situ for a further 5 months, Parents give written informed consent.
Minimum age
6 Months
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Tracheostomy to be removed in less than 5 months time, Heated humidification or HME not tolerated in the past, Not tolerating heated humidification at least 5 nights per week for most of their sleep, Not adherent to heated humidification 3 or more nights per week, Thick airway secretions or other contraindication to stopping heated humidification, Known Cystic Fibrosis (CF), Known Primary Ciliary Dyskinesia (PCD), Known Primary immune deficiency, Palliative care.

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 opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated with blocking also used
Masking / blinding
Blinded (masking 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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 151 0
New Zealand
State/province [1] 151 0

Funding & Sponsors
Funding source category [1] 456 0
Commercial sector/Industry
Name [1] 456 0
Fisher and Paykel Healthcare
Address [1] 456 0
15 Maurice Paykel Place, East Tamaki, Auckland
Country [1] 456 0
New Zealand
Funding source category [2] 457 0
Government body
Name [2] 457 0
Foundation for Research Science and Technology
Address [2] 457 0
AT&T Tower, 15-17 Murphy Street, Thorndon, Wellington
Country [2] 457 0
New Zealand
Funding source category [3] 458 0
Charities/Societies/Foundations
Name [3] 458 0
Joan Mary Reynolds Trust Fellowship
Address [3] 458 0
Starship Hospital
Park Road
Grafton
Auckland
Country [3] 458 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
15 Maurice Paykel Place
East Tamaki
Auckland 2013
Country
New Zealand
Secondary sponsor category [1] 372 0
University
Name [1] 372 0
Auckland Uniservices Ltd
Address [1] 372 0
70 Symonds Street
Auckland
Country [1] 372 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258159 0
Northern X Regional Ethics Committee
Ethics committee address [1] 258159 0
3rd Floor, Unisys Building
650 Great South Road
Penrose, Auckland
Ethics committee country [1] 258159 0
New Zealand
Date submitted for ethics approval [1] 258159 0
Approval date [1] 258159 0
Ethics approval number [1] 258159 0

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

Contacts
Principal investigator
Name 35971 0
Address 35971 0
Country 35971 0
Phone 35971 0
Fax 35971 0
Email 35971 0
Contact person for public queries
Name 9488 0
Geraldine Keogh
Address 9488 0
15 Maurice Paykel Place
East Tamaki Auckland 1706
Country 9488 0
New Zealand
Phone 9488 0
+64 9 5740100
Fax 9488 0
Email 9488 0
geraldine.keogh@fphcare.co.nz
Contact person for scientific queries
Name 416 0
David McNamara
Address 416 0
Department of Paediatrics
University of Auckland
Private Bag 92019
Auckland
Country 416 0
New Zealand
Phone 416 0
+64 9 3737999
Fax 416 0
Email 416 0
d.mcnamara@auckland.ac.nz