HFNC vs NIPPV Following Extubation

Emory University

Status: Enrolling

Conditions: Congenital Heart Disease

Treatments: Procedure: High Flow Nasal Canula following extubation; Procedure: Non-Invasive Positive Pressure Ventilation following extubation

Study type: Interventional

Funder types: Other

Identifiers

NCT05869825

STUDY00003745

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

The high-flow nasal cannula (HFNC)

Active Comparator group

Description:

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).

Treatment:

Procedure: High Flow Nasal Canula following extubation

Non-invasive positive pressure ventilation (NIPPV)

Active Comparator group

Description:

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).

Treatment:

Procedure: Non-Invasive Positive Pressure Ventilation following extubation