Actively Recruiting
Home Initiation of Noninvasive Positive Pressure Ventilation in Children With Medical Complexity
Led by The Hospital for Sick Children · Updated on 2026-05-07
24
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Home Initiation of Noninvasive Positive Pressure Ventilation in Children With Medical Complexity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 5 to 17 years old
- Newly prescribed noninvasive positive pressure ventilation (NiPPV)
- Tolerated a trial of NiPPV while awake
- Provided informed consent
You will not qualify if you...
- Cardiac disease with risk of instability during NiPPV (e.g., heart dysfunction with ejection fraction below 45%, pulmonary hypertension, or single ventricle heart conditions)
- High risk of complications with NiPPV as determined by the child's physician (e.g., pneumothorax or aspiration risk)
- Severe sleep-disordered breathing with peak carbon dioxide level 60 mmHg or higher or apnea-hypopnea index 30 or higher per hour
- Participation in another research study that might affect NiPPV use
- Caregiver or participant not English speaking
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Actively Recruiting
Research Team
R
Reshma Amin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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