Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000673640
Ethics application status
Approved
Date submitted
9/08/2005
Date registered
21/10/2005
Date last updated
7/11/2018
Date data sharing statement initially provided
7/11/2018
Date results information initially provided
7/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study of Overnight Humidification for Children with Tracheostomies
Scientific title
Study of Overnight Humidification for Children with Tracheostomies: A crossover study comparing the effects of a heated humidifier vs a heat and moisture exchanger on mucus viscoelasticity
Secondary ID [1] 199 0
Auckland District Health Board: A+3190
Secondary ID [2] 200 0
NTY/05/08/062
Universal Trial Number (UTN)
Trial acronym
Overnight HCT Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children with tracheostomies 821 0
Condition category
Condition code
Respiratory 885 885 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Heated Humidifier VS Heat and moisture exchanger (HME)
Intervention code [1] 136 0
Treatment: Devices
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1148 0
Mucus visocelasticity
Timepoint [1] 1148 0
After 2 hours and 20 hours of treatment
Secondary outcome [1] 2112 0
Requirement for suctioning overnight.
Timepoint [1] 2112 0

Eligibility
Key inclusion criteria
Children with tracheostomies in situ, Currently in patient, Have had at least one tracheostomy change.
Minimum age
Not stated
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Heated humidification or HME not tolerated in the past, Thick airway secretions or other contraindication to stopping heated humidification, Known Cystic Fibrosis (CF), Known Primary Ciliary Dyskinesia (PCD), Known Primary immune deficiency.

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 Envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated by website www.randomization.com, no blocking or stratification
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
1/09/2005
Actual
26/11/2004
Date of last participant enrolment
Anticipated
Actual
31/01/2007
Date of last data collection
Anticipated
Actual
31/01/2007
Sample size
Target
16
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 134 0
New Zealand
State/province [1] 134 0

Funding & Sponsors
Funding source category [1] 976 0
Commercial sector/Industry
Name [1] 976 0
Fisher and Paykel Healthcare,
Country [1] 976 0
New Zealand
Funding source category [2] 977 0
Charities/Societies/Foundations
Name [2] 977 0
Foundation For Research Science and Technology
Country [2] 977 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
Country
New Zealand
Secondary sponsor category [1] 843 0
University
Name [1] 843 0
Uniservices, Univeristy of Auckland
Address [1] 843 0
Country [1] 843 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2287 0
Starship Hospital, ADHB
Ethics committee address [1] 2287 0
Ethics committee country [1] 2287 0
Australia
Date submitted for ethics approval [1] 2287 0
Approval date [1] 2287 0
Ethics approval number [1] 2287 0

Summary
Brief summary
Introduction:
This study is an observer-blinded cross-over study that aims to compare the short-term effects of two different forms of humidification of inspired gases for children with tracheostomies. The study compares the use of a Heated Humidifier to the use of a Heat and Moisture Exchanger (HME or Swedish nose) in providing humidification of the gases that children with tracheostomies breathe. The study will take place during the time period that children are admitted to the hospital following performance of a tracheostomy. These children are generally well during this period and are admitted while their parents are being trained in the care of a child with a tracheostomy and it is safe for them to go home.

Each child will receive each form of humidification for a 20 hour period. There will be a one night interval and then the child will cross-over and receive the alternate form of humidification for a second 20 hour period. Assessment will be at the baseline for each period, after 2 hours of treatment and after 20 hours of treatment. Assessment will include suctioning of airway secretions for bacterial culture, mucus viscoelasticity, levels of inflammatory markers in airway secretions, oxygen saturation, and clinical examination plus any adverse events or failure to tolerate treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35670 0
Dr David McNamara
Address 35670 0
Paediatric Respiratory and Sleep Medicine
Starship Children's Hospital
1 Park Road
Grafton,
Auckland 1074
New Zealand
Country 35670 0
New Zealand
Phone 35670 0
+64 93797440
Fax 35670 0
Email 35670 0
davidmc@adhb.govt.nz
Contact person for public queries
Name 9325 0
Dr Dr David McNamara
Address 9325 0
Department of Paediatrics
Univeristy of Auckland
Private Bag 92019
Auckland 1020
Country 9325 0
New Zealand
Phone 9325 0
+64 9 3737999
Fax 9325 0
Email 9325 0
d.mcnamara@auckland.ac.nz
Contact person for scientific queries
Name 253 0
Dr Dr David McNamara
Address 253 0
Department of Paediatrics
Univeristy of Auckland
Private Bag 92019
Auckland 1020
Country 253 0
New Zealand
Phone 253 0
+64 9 3737999
Fax 253 0
Email 253 0
d.mcnamara@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not approved by local ethics committee


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.