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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
Study Summary
This trialstudies how NAVA ventilation impacts brain and body hemodynamics in post-op cardiac surgery patients. It will compare NAVA to conventional ventilation over two periods and measure changes in heart, brain and lung function.
Eligible Conditions
- Congenital Heart Defects
- Single Ventricle Heart
- Tetralogy of Fallot
- Hypoplastic Left Heart Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brain oxygen extraction
Brain oxygenation
Brain perfusion
Secondary outcome measures
Brain regional oxygen consumption
Cardiac index
Cardiac output
+7 moreOther outcome measures
Patient comfort
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
196 Previous Clinical Trials
78,999 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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