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RECRUITING
NCT05881031
NA

Home Initiation of Noninvasive Positive Pressure Ventilation in Children With Medical Complexity

Sponsor: The Hospital for Sick Children

View on ClinicalTrials.gov

Summary

Children with medical complexity (CMC) often have trouble breathing at night and need to use a breathing machine. This breathing machine is called noninvasive positive pressure ventilation (NiPPV). The use of NiPPV has been shown to improve quality of life and survival in children. Before it is used, NiPPV must first be tested to see what the correct 'machine settings' are for each child. This is usually done in the sleep laboratory at the hospital during a one-night stay. However, sleep studies in the hospital are disruptive and hard for CMC and their families because of the new environment and limited access to the equipment, supplies, comfort items and the routine their child has at home. Patients and families would prefer to start NiPPV at home but there needs to be more research on this to make sure it is possible and safe. This study will evaluate a new model of care to start NiPPV in the home. CMC aged 5-17 years old and starting NiPPV will be assigned at random, like a coin toss, to start NiPPV in the home or to start NiPPV in the sleep laboratory. The investigators will assess the feasibility and safety of the two ways to start NiPPV. This study will be the first step towards developing a study to evaluate if home NiPPV starts are effective. Starting NiPPV at home has the potential to improve the use of NiPPV (ie early adherence predicts long-term use) resulting in both medical benefits as well as improved quality of life for CMC and their families.

Official title: Single Site Feasibility and Safety Study of Home Initiation of Noninvasive Positive Pressure Ventilation in Children With Medical Complexity

Key Details

Gender

All

Age Range

60 Months - 215 Months

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2023-06-21

Completion Date

2026-12-01

Last Updated

2025-06-05

Healthy Volunteers

No

Interventions

OTHER

Home Initiation of NiPPV

Initiation of NiPPV in the home environment through the utilization of an awake NiPPV titration, oximetries, and telemonitoring.

Locations (1)

The Hospital for Sick Children

Toronto, Ontario, Canada