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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from hospital admission until hospital discharge up to a year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
My child is under 1 year old or weighs 10 kg or less and had heart surgery.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To compare the effectiveness in avoiding extubation failures of High Flow Nasal Cannula (HFNC) vs Non-Invasive Positive Pressure Ventilation (NIPPV)
Secondary outcome measures
Difference of patients' clinical hemodynamical status at discharge
Length of hospital stay difference between treatment groups
Patient's clinical breathing status at discharge

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).

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,373 Total Patients Enrolled
Asaad Beshish, MDPrincipal InvestigatorEmory University

Media Library

High Flow Nasal Canula following extubation Clinical Trial Eligibility Overview. Trial Name: NCT05869825 — N/A
Congenital Heart Disease Research Study Groups: The high-flow nasal cannula (HFNC), Non-invasive positive pressure ventilation (NIPPV)
Congenital Heart Disease Clinical Trial 2023: High Flow Nasal Canula following extubation Highlights & Side Effects. Trial Name: NCT05869825 — N/A
High Flow Nasal Canula following extubation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05869825 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there available slots for candidates in this experiment?

"Data hosted on the clinicaltrials.gov website verifies that this particular study is not accepting recruits at present. It was initially posted June 1st 2023 and last modified May 19th 2023, however there are currently 361 other trials enrolling participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
HFNC vs NIPPV Following Extubation
Asaad Beshish 2024. "HFNC vs NIPPV Following Extubation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05869825.
~133 spots leftby May 2025
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