HFNC vs NIPPV for Congenital Heart Disease Post-Surgery

Recruiting at 1 trial location

Overseen By Asaad Beshish, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Tracheostomy, ECMO, Low birth weight, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 weeks

200 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{3 5 6 7 8}

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

My child is under 1 year old or weighs 10 kg or less and had heart surgery.

Exclusion Criteria

You need ECMO support before surgery.

My birth weight was under 2 Kg.

You were born less than 35 weeks into pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either High Flow Nasal Cannula (HFNC) or Non-Invasive Positive Pressure Ventilation (NIPPV) following extubation after cardiac surgery

Up to 2 weeks

Continuous monitoring in CICU

Follow-up

Participants are monitored for safety and effectiveness after treatment until hospital discharge or second instance of extubation failure

Up to 1 year

Regular monitoring until discharge

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?

Group I: The high-flow nasal cannula (HFNC) Active Control 1 Intervention

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).

Group II: Non-invasive positive pressure ventilation (NIPPV) Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

In a study involving 372 preterm infants, high-flow nasal cannula (HFNC) was associated with a significantly higher rate of treatment failure (31%) compared to nasal continuous positive airway pressure (NCPAP) or nasal intermittent positive-pressure ventilation (NIPPV) (16%) after extubation.

Factors such as histologic chorioamnionitis, treated patent ductus arteriosus, and younger corrected gestational age were identified as independent predictors of treatment failure when using HFNC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of High-Flow Nasal Cannula in Preterm Infants After Extubation. Uchiyama, A., Okazaki, K., Kondo, M., et al.[2021]

In a study of 120 patients with acute hypoxemic respiratory failure, high-flow nasal cannula (HFNC) treatment resulted in significantly lower rates of abdominal distension compared to noninvasive positive-pressure ventilation (NPPV), indicating a safer profile for HFNC.

Both HFNC and NPPV showed similar effectiveness in preventing respiratory failure post-extubation, with no significant differences in key respiratory parameters or re-intubation rates, suggesting that HFNC may be a preferable option due to its lower incidence of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of outcomes of high-flow nasal cannula and noninvasive positive-pressure ventilation in patients with hypoxemia and various APACHE II scores after extubation. Shang, X., Wang, Y.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38389199/

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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37058243/

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.

4. bmcpulmmed.biomedcentral.com bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-024-02901-5

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.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0147956323001103

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10882916/

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.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07059689?cond=Heart+Diseases

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 ...

8. bmjpaedsopen.bmj.com bmjpaedsopen.bmj.com/content/7/1/e001870

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 ...