HFNC vs NIPPV Following Extubation

Congenital Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05869825
• Other study ID #: STUDY00003745
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2026

Study information

• Verified date: April 2024
• Source: Emory University
• Contact: Asaad Beshish, MD
• Phone: 404.785.6953
• Email: beshisha[@]kidsheart.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: May 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients who remain intubated for >/= 4 weeks
• Patients who have a tracheostomy in place 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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Procedure:
• High Flow Nasal Canula following extubation
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 need to be re-intubated with oxygen.
• Non-Invasive Positive Pressure Ventilation following extubation
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 need to be re-intubated with oxygen.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After surgery up to 2 weeks
Secondary	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	At hospital discharge up to a year
Secondary	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.	At hospital discharge up to a year
Secondary	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	From hospital admission until hospital discharge up to a year