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

RecruitingNAAges 60 Months - 215 MonthsAllThe Hospital for Sick Children
NCT05881031 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 5-17 years old 2. Newly prescribed NiPPV 3. Tolerated awake NiPPV trial 4. Provides informed consent Exclusion Criteria: 1. Cardiac disease at risk of hemodynamic instability with NiPPV initiation (eg cardiac dysfunction (ejection fraction \<45%), pulmonary hypertension (mean pulmonary artery pressure ≥ 20 mmHg on right heart catheterization or suggestive echocardiogram findings in the opinion of a pediatric cardiologist), or single ventricle) 2. At high risk of complications with NiPPV in the opinion of the child's physician (eg pneumothorax and aspiration risk) 3. Severe sleep disordered breathing with peak CO2 ≥ 60mmHg or apnea-hypopnea index (AHI)≥ 30/hr (AHI measures the number of respiratory events per hour) 4. Participation in concurrent research study that may affect NiPPV adherence (proposed primary outcome of full study) 5. Exclusion of study participants if the caregiver or participant is not English speaking
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What it tests

  • Home Initiation of NiPPV
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Where

1 site
The Hospital for Sick Children
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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