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NAVA Ventilation for Congenital Heart Disease
N/A
Recruiting
Led By Guillaume Emeriaud, Dr
Research Sponsored by St. Justine's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a more natural form of mechanical breathing support in children who have had heart surgery. It aims to see if this method improves blood flow and oxygen levels by reducing chest pressure, which helps the heart work better. This new form of ventilation uses the body's natural signals to deliver synchronized breaths, showing benefits over older methods.
Eligible Conditions
- Congenital Heart Defects
- Tetralogy of Fallot
- Hypoplastic Left Heart Syndrome
- Single Ventricle Heart
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Brain oxygen extraction
Brain oxygenation
Brain perfusion
Secondary study objectives
Brain regional oxygen consumption
Cardiac index
Cardiac output
+7 moreOther study objectives
Patient comfort
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Neurally adjusted ventilatory assist firstExperimental Treatment1 Intervention
Ventilation in NAVA mode then ventilation in conventional mode
Group II: Conventional ventilation firstExperimental Treatment1 Intervention
Ventilation in conventional mode then ventilation in NAVA mode
Find a Location
Who is running the clinical trial?
St. Justine's HospitalLead Sponsor
200 Previous Clinical Trials
85,810 Total Patients Enrolled
Guillaume Emeriaud, DrPrincipal InvestigatorSt. Justine's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You will have a breathing tube removed in the operating room or within the next hour.You have a medical order that limits your critical care treatment.You are not scheduled to use a ventilator within 2 hours of being admitted.You are unable to have a nasogastric NAVA tube placed.You have had a serious injury to a specific part of your brain in the past.You were admitted to the pediatric intensive care unit after specific heart surgeries or other surgeries with a risk of heart or lung problems after the operation.You have an open chest, uncontrolled shock, or need for a neuromuscular blockade. You may become eligible once these issues are resolved.Both sides of your diaphragm are not working properly.
Research Study Groups:
This trial has the following groups:- Group 1: Neurally adjusted ventilatory assist first
- Group 2: Conventional ventilation first
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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