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HFNC vs NIPPV for Congenital Heart Disease Post-Surgery

N/A

Waitlist Available

Led By Asaad Beshish, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All patients admitted to the CICU following cardiac surgery for CHD who are </= 1 year of age and/or weight </= 10 kg

Be younger than 18 years old

Must not have

Patients with birth weight < 2 Kg

Patients who remain intubated for >/= 4 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from hospital admission until hospital discharge up to a year

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare outcomes of 200 infants after cardiac surgery to determine which respiratory support method (HFNC or NIPPV) is best for extubation after surgery.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Both HFNC and NIPPV are standard care options with potential side effects including discomfort or nasal irritation from the devices, breathing difficulties if settings aren't optimal, and possible skin breakdown where equipment contacts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My birth weight was under 2 Kg.

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I have been on a breathing machine for 4 weeks or more.

Select...

I had a tracheostomy before my heart surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at hospital discharge up to a year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at hospital discharge up to a year

This trial's timeline: 3 weeks for screening, Varies for treatment, and at hospital discharge up to a year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To compare the effectiveness in avoiding extubation failures of High Flow Nasal Cannula (HFNC) vs Non-Invasive Positive Pressure Ventilation (NIPPV)

Secondary study objectives

Difference of patients' clinical hemodynamical status at discharge

Length of hospital stay difference between treatment groups

Patient's clinical breathing status at discharge

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: The high-flow nasal cannula (HFNC)Active Control1 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 Control1 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).

0 / 4Eligibility criteria met