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

Trial Summary

What is the purpose of this trial?

This study has the goal to determine the best method of respiratory support following extubation after cardiac surgery (CS). After cardiac surgery for Congenital Heart Disease (CHD), patients remain intubated until the cardiac team determines it is safe for the patient to undergo a trial of extubation. Two common methods of respiratory support following extubation are High Flow Nasal Cannula (HFNC) and Non Invasive Positive Pressure Ventilation (NIPPV). There is currently a gap in data comparing High Flow Nasal Cannula and Non-Invasive Positive Pressure Ventilation in infants (age 0-1) in regard to extubation failure and overall outcomes. This study will monitor the health outcomes of 200 infants (0 - 1 year) with CHD following cardiac surgery in the Cardiac Intensive Care Unit (CICU) at Children's Healthcare of Atlanta (CHOA). This will be done by assigning the respiratory support method each child will receive following extubation after cardiac surgery. Health outcomes will be monitored until discharge or until the second instance of extubation failure. Both study arms are standard-of-care respiratory support methods in the CHOA CICU. The investigators aim to determine which of these two methods has fewer risk factors when used with infants.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the treatment High Flow Nasal Canula and Non-Invasive Positive Pressure Ventilation following extubation for Congenital Heart Disease Post-Surgery?

Research shows that both High Flow Nasal Cannula (HFNC) and Non-Invasive Positive Pressure Ventilation (NIPPV) are used to support patients after extubation, with studies indicating that HFNC is not inferior to NIPPV in preventing extubation failure in heart failure patients. This suggests potential effectiveness in similar post-surgery scenarios for congenital heart disease. ^{1 2 3 4 5}

Is it safe to use high-flow nasal cannula (HFNC) or noninvasive positive pressure ventilation (NIPPV) after surgery?

Research shows that both high-flow nasal cannula (HFNC) and noninvasive positive pressure ventilation (NIPPV) are generally safe for use in humans after surgery, including in preterm infants and patients with brain injuries. However, HFNC may not be as effective as NIPPV in preventing the need for reintubation in some cases. ^{1 2 3 4 6}

How does the treatment of HFNC vs NIPPV differ for congenital heart disease post-surgery?

The treatment using High Flow Nasal Cannula (HFNC) and Non-Invasive Positive Pressure Ventilation (NIPPV) after surgery for congenital heart disease is unique because it focuses on providing respiratory support without the need for invasive procedures. HFNC delivers a high flow of oxygen through the nose, which can be more comfortable and easier to tolerate, while NIPPV provides breathing support through a mask, helping to keep the airways open and reduce the work of breathing. ^{1 3 4 7 8}

Research Team

Asaad Beshish, MD

Principal Investigator

Emory University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of High-Flow Nasal Cannula in Preterm Infants After Extubation. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Prevalence of Reintubation Within 24 Hours of Extubation in Bronchiolitis: Retrospective Cohort Study Using the Virtual Pediatric Systems Database. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Association of Noninvasive Respiratory Support with Extubation Outcomes in Brain-injured Patients Receiving Mechanical Ventilation: A Secondary Analysis of the ENIO Prospective Observational Study. [2023]

4. India pubmed.ncbi.nlm.nih.gov

Comparative evaluation of high-flow nasal cannula oxygenation vs nasal intermittent ventilation in postoperative paediatric patients operated for acyanotic congenital cardiac defects. [2023]

5. Egypt pubmed.ncbi.nlm.nih.gov

High-Flow Nasal Cannula versus Noninvasive Positive Pressure Ventilation in Patients with Heart Failure after Extubation: An Observational Cohort Study. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Effectiveness of high-flow nasal cannulae compared with noninvasive positive-pressure ventilation in preventing reintubation in patients receiving prolonged mechanical ventilation. [2023]

7. England 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. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Can high-flow nasal cannula reduce the rate of reintubation in adult patients after extubation? A meta-analysis. [2018]