Congenital Heart DiseaseNCT05869825
HFNC vs NIPPV Following Extubation
A study testing High Flow Nasal Canula following extubation and Non-Invasive Positive Pressure Ventilation following extubation in people with Congenital Heart Disease, run by Emory University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- High Flow Nasal Canula following extubation and Non-Invasive Positive Pressure Ventilation following extubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients admitted to the CICU following cardiac surgery for CHD who are </= 1 year of age and/or weight </= 10 kg
Who cannot join
- Patients who remain intubated for >/= 4 weeks
- Patients who have a tracheostomy prior to their cardiac surgery
- Patient enrolled in a competing research study
- Patients requiring extracorporeal membrane oxygenation (ECMO) support preoperatively
- Patients with birth weight < 2 Kg.
- Gestational age < 35 weeks at birth.
- Patients with extracardiac anomalies more than minor severity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Arthur M. Blank Hospital | Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
About this study
Official title: High Flow Nasal Cannula and Non-Invasive Positive Pressure Ventilation Following Extubation in Infants After Cardiac Surgery for Congenital Heart Disease: A Randomized Clinical 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.
Read the detailed description
This study aims to answer an important clinical question that all providers struggle with: how to optimize respiratory support following extubation in Infants After Cardiac Surgery (CS) for Congenital Heart Disease (CHD). The high morbidity and at times mortality associated with failed extubation events demonstrates this clearly, as extubation failure (EF) is stressful to this fragile population and results in hemodynamic compromise as well as airway trauma due to manipulation of the airway.
This study aims to: 1) comparatively examine which mode of respiratory support (HFNC vs NIPPV) after extubation is more effective at lowering rates of EF, and 2) examine clinical risk factors, outside of the respiratory support model (HFNC vs. NIPPV), that are associated with EF in patients with CHD after CS.
These infants often remain endotracheally intubated on mechanical ventilatory support upon return to the Cardiac Intensive Care Unit (CICU). These patients undergo a trial of extubation at the discretion of the CICU team when deemed safe. Studies have shown that approximately 3-27% of patients with CHD fail extubation after cardiac surgery. Risk factors for extubation failure (EF) are complex surgical repair, younger age, smaller patients, presence of airway anomalies, genetic abnormalities, pulmonary hypertension, use of cardiopulmonary bypass (CPB), hypothermia, atelectasis, lung injury, phrenic and diaphragmatic nerve injury, and prolonged open sternotomy. Patients with CHD who are successfully extubated using NIPPV have been shown to have shorter lengths of stay, while studies in pre-term infants without CHD showed NIPPV reduced EF compared to hood/tent oxygen, or HFNC. Other studies have shown HFNC to decrease the need for intubation in infants with respiratory failure and may improve respiratory mechanics through unidirectional flow in the upper airway, decreasing dead space, improving minute ventilation, pulmonary compliance, and distending airway pressure. This support ultimately reduces the work of breathing and oxygen consumption, while enhancing oxygen delivery.
Despite the use of HFNC and NIPPV to support patients following extubation, there is limited data on the comparative effectiveness of HFNC versus NIPPV to prevent EF in infants with CHD after CS. The investigators hypothesize that the use of HFNC will be associated with lower rates of EF, and a shorter length of stay when compared to NIPPV.
- Conditions
- Congenital Heart Disease
- Being tested
- High Flow Nasal Canula following extubation, Non-Invasive Positive Pressure Ventilation following extubation
- Keywords
- Cardiac surgery for CHD, Cardiac Intensive Care Unit
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal Canula following extubationProcedure or surgery
Also called HFNC
Participants in this group will be randomized to receive High Flow Nasal Cannula support after extubation. The patient will be clinically monitored, and respiratory support will be escalated per a specific flow sheet. The patient will remain on this assigned air support method until they are either removed entirely from air support or require re-intubation.
Non-Invasive Positive Pressure Ventilation following extubationProcedure or surgery
Also called NIPPV
Participants in this group will be randomized to receive NIPPV respiratory support following extubation. The patient will be clinically monitored, and respiratory support will be escalated per a specific flow sheet. The patient will remain on this assigned air support method until they are either removed entirely from air support or require re-intubation.
| Study group | Role | What they receive |
|---|---|---|
| The high-flow nasal cannula (HFNC) | Active comparator | 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). Receives: Procedure: High Flow Nasal Canula following extubation |
| Non-invasive positive pressure ventilation (NIPPV) | Active comparator | 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). Receives: Procedure: Non-Invasive Positive Pressure Ventilation following extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effectiveness in avoiding extubation failures of High Flow Nasal Cannula (HFNC) vs Non-Invasive Positive Pressure Ventilation (NIPPV)
Rates of extubation failures (EF) will be compared among both groups. Data will be collected from the hospital electronic medical record system.
Measured: After surgery up to 2 weeks
Secondary outcomes (3)
Patient's clinical breathing status at discharge
The research team will review the hospital's electronic medical record and check the patient's breathing status (oxygen saturation on room air) after the patient's hospital discharge
Measured: At hospital discharge up to a year
Difference of patients' clinical hemodynamical status at discharge
The research team will review the hospital's electronic medical record and check the patient's vital signs (blood pressure and heart rate) to determine the clinical hemodynamical status at discharge.
Measured: At hospital discharge up to a year
Length of hospital stay difference between treatment groups
The research team will review the hospital's electronic medical records after the patient's hospital discharge. The length of hospital stay (days) will be calculated from time of hospital admission until discharge
Measured: From hospital admission until hospital discharge up to a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start27 Feb 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asaad Beshish, Emory University
- Investigators
- Asaad Beshish, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869825
- Sponsor's protocol ID
- STUDY00003745
- Other IDs
- 2025P011091
- Status last verified
- Jul 2026
- First submitted
- 30 Mar 2023
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research team will present the analyzed data at conferences and will also be submitted for publication.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula and Non-Invasive Positive Pressure Ventilation Following Extubation in Infants After Cardiac Surgery for Congenital Heart Disease: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05869825
- Acronym / sponsor ID
- STUDY00003745
- Conditions
- Congenital Heart Disease
- Keywords
- Cardiac surgery for CHD, Cardiac Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to answer an important clinical question that all providers struggle with: how to optimize respiratory support following extubation in Infants After Cardiac Surgery (CS) for Congenital Heart Disease (CHD). The high morbidity and at times mortality associated with failed extubation events demonstrates this clearly, as extubation failure (EF) is stressful to this fragile population and results in hemodynamic compromise as well as airway trauma due to manipulation of the airway.
This study aims to: 1) comparatively examine which mode of respiratory support (HFNC vs NIPPV) after extubation is more effective at lowering rates of EF, and 2) examine clinical risk factors, outside of the respiratory support model (HFNC vs. NIPPV), that are associated with EF in patients with CHD after CS.
These infants often remain endotracheally intubated on mechanical ventilatory support upon return to the Cardiac Intensive Care Unit (CICU). These patients undergo a trial of extubation at the discretion of the CICU team when deemed safe. Studies have shown that approximately 3-27% of patients with CHD fail extubation after cardiac surgery. Risk factors for extubation failure (EF) are complex surgical repair, younger age, smaller patients, presence of airway anomalies, genetic abnormalities, pulmonary hypertension, use of cardiopulmonary bypass (CPB), hypothermia, atelectasis, lung injury, phrenic and diaphragmatic nerve injury, and prolonged open sternotomy. Patients with CHD who are successfully extubated using NIPPV have been shown to have shorter lengths of stay, while studies in pre-term infants without CHD showed NIPPV reduced EF compared to hood/tent oxygen, or HFNC. Other studies have shown HFNC to decrease the need for intubation in infants with respiratory failure and may improve respiratory mechanics through unidirectional flow in the upper airway, decreasing dead space, improving minute ventilation, pulmonary compliance, and distending airway pressure. This support ultimately reduces the work of breathing and oxygen consumption, while enhancing oxygen delivery.
Despite the use of HFNC and NIPPV to support patients following extubation, there is limited data on the comparative effectiveness of HFNC versus NIPPV to prevent EF in infants with CHD after CS. The investigators hypothesize that the use of HFNC will be associated with lower rates of EF, and a shorter length of stay when compared to NIPPV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The high-flow nasal cannula (HFNC) | Active comparator | Procedure: High Flow Nasal Canula following extubationThe 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 (NIPPV) | Active comparator | Procedure: Non-Invasive Positive Pressure Ventilation following extubationNon-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 may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All patients admitted to the CICU following cardiac surgery for CHD who are </= 1 year of age and/or weight </= 10 kg
Key exclusion criteria (7 listed)
- Patients who remain intubated for >/= 4 weeks
- Patients who have a tracheostomy prior to their cardiac surgery
- Patient enrolled in a competing research study
- Patients requiring extracorporeal membrane oxygenation (ECMO) support preoperatively
- Patients with birth weight < 2 Kg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Flow Nasal Canula following extubationAlso: HFNCParticipants in this group will be randomized to receive High Flow Nasal Cannula support after extubation. The patient will be clinically monitored, and respiratory support will be escalated per a specific flow sheet. The patient will remain on this assigned air support method until they are either removed entirely from air support or require re-intubation. | Procedure or surgery | The high-flow nasal cannula (HFNC) |
| Non-Invasive Positive Pressure Ventilation following extubationAlso: NIPPVParticipants in this group will be randomized to receive NIPPV respiratory support following extubation. The patient will be clinically monitored, and respiratory support will be escalated per a specific flow sheet. The patient will remain on this assigned air support method until they are either removed entirely from air support or require re-intubation. | Procedure or surgery | Non-invasive positive pressure ventilation (NIPPV) |
Primary outcome
To compare the effectiveness in avoiding extubation failures of High Flow Nasal Cannula (HFNC) vs Non-Invasive Positive Pressure Ventilation (NIPPV)
Time frame: After surgery up to 2 weeks
Rates of extubation failures (EF) will be compared among both groups. Data will be collected from the hospital electronic medical record system.
3 secondary outcomes
Patient's clinical breathing status at discharge
Time frame: At hospital discharge up to a year
Difference of patients' clinical hemodynamical status at discharge
Time frame: At hospital discharge up to a year
Length of hospital stay difference between treatment groups
Time frame: From hospital admission until hospital discharge up to a year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No. The research team will present the analyzed data at conferences and will also be submitted for publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Asaad Beshish, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal Canula following extubation and Non-Invasive Positive Pressure Ventilation following extubation in people with Congenital Heart Disease, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asaad Beshish, MD (404.785.6953, beshisha@kidsheart.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the effectiveness in avoiding extubation failures of High Flow Nasal Cannula (HFNC) vs Non-Invasive Positive Pressure Ventilation (NIPPV) (time frame: After surgery up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.