Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05881031
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-05-01
Brief Title:
Home Initiation of Noninvasive Positive Pressure Ventilation in Children With Medical Complexity
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
Single Site Feasibility and Safety Study of Home Initiation of Noninvasive Positive Pressure Ventilation in Children With Medical Complexity
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Children with medical complexity CMC are increasingly prescribed noninvasive positive pressure ventilation NiPPV for chronic respiratory failure In our clinical experience patients and families would prefer NiPPV initiation in the home environment but this is not standard of care This proposal will evaluate the feasibility and safety of an innovative model of care for NiPPV initiation in the home environment utilizing remote telemonitoring compared to usual care which is in-hospital polysomnography PSG laboratory-based initiation
The incidence of CMC requiring NiPPV is exponentially growing NiPPV effectively corrects abnormal gas exchange improves sleep quality and reduces symptoms of chronic respiratory failure The use of NiPPV has been associated with increased survival and improved health-related quality of life HRQOL To ensure effectiveness NiPPV must be used for all periods of sleep and settings must be individually-titrated Unfortunately poor adherence results in many CMC being undertreated for chronic respiratory failure Successful NiPPV initiation is critical because early negative experiences are commonly reported barriers to adherence6 and early usage predicts longer term use Standard of care is the initiation and titration of NiPPV during a one-night in-hospital PSG A PSG is challenging for CMC and families due to their medical fragility and lasting effects of travel and a disrupted routine the significant amount of equipment and supplies that must be brought to the study as well as the financial implications and additional psychosocial stress for caregivers In addition negative experiences with NiPPV may be exacerbated by introduction of the therapy in an unfamiliar PSG laboratory with burdensome monitoring Furthermore a one-night PSG provides limited sleep data that may not be representative of dynamic and variable sleeping patterns that occur in the comfort of ones home
Recent technological advances in remote NiPPV monitoring coupled with a shift to virtual care models has enabled a patient and family centered opportunity to bypass the PSG laboratory and initiate NiPPV at home Remote NiPPV monitoring extends data collection beyond discrete health care encounters and provides real-time data on adherence and efficacy that can be wirelessly transmitted to facilitate setting adjustment by clinicians Home NiPPV initiation is increasingly being requested by patients and caregivers The potential benefits of this innovative care model include increasing patient and family empowerment improving the delivery of high quality patient-centred care at home and optimizing NiPPV use Although there is growing data in the adult population to support home NiPPV initiation via telemonitoring this cannot be simply extrapolated to CMC There are key differences in the etiology and manifestation of chronic respiratory failure in CMC compared to adults Furthermore family caregivers play an important role in NiPPV acceptance and adherence
Canadian guidelines acknowledge the lack of evidence for the setting in which NiPPV is initiated Home NiPPV initiation in CMC is a novel model of care that may result in large health system impacts but requires a feasibility study before embarking on a large-scale trial
The incidence of CMC requiring NiPPV is exponentially growing NiPPV effectively corrects abnormal gas exchange improves sleep quality and reduces symptoms of chronic respiratory failure The use of NiPPV has been associated with increased survival and improved health-related quality of life HRQOL To ensure effectiveness NiPPV must be used for all periods of sleep and settings must be individually-titrated Unfortunately poor adherence results in many CMC being undertreated for chronic respiratory failure Successful NiPPV initiation is critical because early negative experiences are commonly reported barriers to adherence6 and early usage predicts longer term use Standard of care is the initiation and titration of NiPPV during a one-night in-hospital PSG A PSG is challenging for CMC and families due to their medical fragility and lasting effects of travel and a disrupted routine the significant amount of equipment and supplies that must be brought to the study as well as the financial implications and additional psychosocial stress for caregivers In addition negative experiences with NiPPV may be exacerbated by introduction of the therapy in an unfamiliar PSG laboratory with burdensome monitoring Furthermore a one-night PSG provides limited sleep data that may not be representative of dynamic and variable sleeping patterns that occur in the comfort of ones home
Recent technological advances in remote NiPPV monitoring coupled with a shift to virtual care models has enabled a patient and family centered opportunity to bypass the PSG laboratory and initiate NiPPV at home Remote NiPPV monitoring extends data collection beyond discrete health care encounters and provides real-time data on adherence and efficacy that can be wirelessly transmitted to facilitate setting adjustment by clinicians Home NiPPV initiation is increasingly being requested by patients and caregivers The potential benefits of this innovative care model include increasing patient and family empowerment improving the delivery of high quality patient-centred care at home and optimizing NiPPV use Although there is growing data in the adult population to support home NiPPV initiation via telemonitoring this cannot be simply extrapolated to CMC There are key differences in the etiology and manifestation of chronic respiratory failure in CMC compared to adults Furthermore family caregivers play an important role in NiPPV acceptance and adherence
Canadian guidelines acknowledge the lack of evidence for the setting in which NiPPV is initiated Home NiPPV initiation in CMC is a novel model of care that may result in large health system impacts but requires a feasibility study before embarking on a large-scale trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None