HFNC vs NIPPV for Congenital Heart Disease Post-Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates which breathing support method works best for babies after heart surgery for congenital heart disease. It compares two common methods: High Flow Nasal Cannula, which delivers warm, moist air through the nose, and Non-Invasive Positive Pressure Ventilation, which uses a mask to gently push air into the lungs. The goal is to determine which method aids better recovery without requiring another breathing tube. Babies who have undergone heart surgery and are under a year old or weigh less than 10 kilograms may qualify. As an unphased trial, this study allows families to contribute to important research that could enhance recovery methods for future patients.
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications.
What prior data suggests that these respiratory support methods are safe for infants with congenital heart disease post-surgery?
Research shows that both High Flow Nasal Cannula (HFNC) and Non-Invasive Positive Pressure Ventilation (NIPPV) are generally safe for infants after heart surgery. Studies have found that HFNC can reduce the need for reintubation and shorten the stay in the Cardiac Intensive Care Unit (CICU) for children. It also helps maintain steady oxygen levels and supports heart function.
NIPPV, in contrast, effectively assists infants in breathing after extubation. A review found that NIPPV improved breathing and eased cardiac strain. While there is a small chance of failure, most cases succeed.
Both treatments are well-tolerated and commonly used in the CICU at Children's Healthcare of Atlanta. They aim to provide effective breathing support without invasive procedures.12345Why are researchers excited about this trial?
Researchers are excited about the trial comparing High Flow Nasal Cannula (HFNC) and Non-Invasive Positive Pressure Ventilation (NIPPV) because these methods offer unique, less invasive respiratory support for children recovering from congenital heart surgery. Unlike traditional methods that often require an endotracheal tube, both HFNC and NIPPV deliver oxygen without inserting a tube into the airway, which can reduce discomfort and potential complications. HFNC is distinctive because it provides warmed, humidified oxygen at varying flow rates, while NIPPV delivers oxygen-enriched air under pressure through a mask or nasal prongs. This trial aims to determine which method is more effective in supporting young patients after surgery, potentially improving recovery outcomes with less invasive techniques.
What evidence suggests that this trial's treatments could be effective for infants with congenital heart disease post-surgery?
This trial will compare high-flow nasal cannula (HFNC) with non-invasive positive pressure ventilation (NIPPV) for infants after congenital heart disease surgery. Previous studies have shown that HFNC lowers the chances of needing to reinsert a breathing tube and shortens the time children spend in the cardiac intensive care unit (CICU) after heart surgery. HFNC also stabilizes oxygen levels and reduces the heart's workload. Meanwhile, NIPPV effectively helps infants breathe better and prevents serious breathing problems after heart surgery. NIPPV can improve oxygen levels and ease the heart's burden. Both methods support infants after heart surgery, but HFNC might reduce the need for reintubation and shorten CICU stays.35678
Who Is on the Research Team?
Asaad Beshish, MD
Principal Investigator
Emory University
Are You a Good Fit for This Trial?
This trial is for infants (0-1 year) with Congenital Heart Disease who weigh under 10 kg and are in the Cardiac Intensive Care Unit after heart surgery. It's not for those intubated over 4 weeks, with a tracheostomy before surgery, enrolled in another study, needing ECMO before surgery, born under 2 kg or less than 35 weeks gestation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either High Flow Nasal Cannula (HFNC) or Non-Invasive Positive Pressure Ventilation (NIPPV) following extubation after cardiac surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment until hospital discharge or second instance of extubation failure
What Are the Treatments Tested in This Trial?
Interventions
- High Flow Nasal Canula following extubation
- Non-Invasive Positive Pressure Ventilation following extubation
Trial Overview
The trial compares two respiratory support methods post-extubation: High Flow Nasal Cannula (HFNC) and Non-Invasive Positive Pressure Ventilation (NIPPV). The goal is to see which method leads to better outcomes for infants after cardiac surgery.
How Is the Trial Designed?
2
Treatment groups
Active Control
The high flow nasal cannula (HFNC) is a unique mode of respiratory support that delivers warmed, humidified oxygen with a wide range of fractions of inspired oxygen (FiO2) and flow rate (liters/min) without an invasive device such as an endotracheal tube (breathing tube).
Non-invasive positive pressure ventilation (NPPV or NIPPV) is a unique mode of respiratory support that delivers pressurized, oxygen-enriched gas to the airway via the nose and/or oropharynx without a more invasive device such as an endotracheal tube (breathing tube).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
Published Research Related to This Trial
Citations
Use of high-flow nasal cannula versus other noninvasive ...
High-flow nasal cannula is more effective in reducing the rate of postextubation failure compared to other forms of noninvasive ventilation techniques ...
2.
healthcare-bulletin.co.uk
healthcare-bulletin.co.uk/article/optimizing-pediatric-cardiac-postoperative-recovery-efficacy-of-high-flow-nasal-cannula-therapy-in-enhancing-physiological-stability-and-reducing-reintubation-rates-2499/Efficacy of High Flow Nasal Cannula Therapy in Enhancing ...
Conclusion: HFNC therapy significantly enhances respiratory mechanics, reduces cardiac workload, stabilizes oxygen saturation, and alleviates ...
Efficacy of prophylactic high-flow nasal cannula therapy for ...
HFNC was used for 24 h after extubation at a 2 L/kg/min flow rate. The primary outcome was the incidence of PPC within 48 h after extubation.
Comparison of high-flow nasal cannula oxygenation and non ...
For pediatric patients post-CHS, HFNC appears to be more effective than NIV in reducing reintubation rates and shortening the CICU stay.
Cardiopulmonary outcomes following high flow nasal ...
Compared with traditional oxygen therapies, HFNC may improve systemic oxygen saturation, reduce heart rate and partial blood pressure, and improve the PaO2/FiO2 ...
Comparison of high-flow nasal cannula oxygenation and ...
For pediatric patients post-CHS, HFNC appears to be more effective than NIV in reducing reintubation rates and shortening the CICU stay.
High-Flow Nasal Cannula vs. NIV After Extubation in ...
This study aims to compare the extubation success rate between the use of High Flow Nasal Cannula (HFNC) and Non-Invasive Ventilation (NIV) in pediatric ...
Application of high-flow nasal cannula in fibreoptic ...
The purpose of this study was to compare the effectiveness and safety of high-flow nasal cannula (HFNC) and conventional oxygen therapy (COT) in fibreoptic ...
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