Humidification for Children with Tracheostomies Study

Humidification for Children with Tracheostomies Study: A cross-over trial comparing a heated humidifier to a heat and moisture exchanger.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000263695

Acronym

HCT study

Enrollment

Registered

2005-09-02

Start date

2004-11-01

Completion date

Unknown

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

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

6 Months to No maximum

Healthy volunteers

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.

Outcome results