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Study of Overnight Humidification for Children with Tracheostomies

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000673640
Acronym
Overnight HCT Study
Enrollment
12
Registered
2005-10-21
Start date
2004-11-26
Completion date
2007-01-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

Heated Humidifier VS Heat and moisture exchanger (HME)

Sponsors

Fisher and Paykel Healthcare
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
0 to 18 Years
Healthy volunteers
No

Inclusion criteria

Children with tracheostomies in situ, Currently in patient, Have had at least one tracheostomy change.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026