ACTRN12605000263695CompletedNot Applicable
Humidification for Children with Tracheostomies Study: A cross-over trial comparing a heated humidifier to a heat and moisture exchanger.
Fisher and Paykel Healthcare0 sites24 target enrollmentStarted: September 2, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 6 Months to ot stated (—)
- Sex
- All
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.
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.
Investigators
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