Health TrialsbyHealthPanel

HFNC vs NIPPV Following Extubation

ConditionCongenital Heart Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 1
SponsorEmory University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • High Flow Nasal Canula following extubation

    Procedure/Surgery

    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 extubation

    Procedure/Surgery

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: The high-flow nasal cannula (HFNC)Active comparator 1 intervention
Group B: Non-invasive positive pressure ventilation (NIPPV)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
After surgery up to 2 weeks

Secondary outcomes

1

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

Time frame
At hospital discharge up to a year
2

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.

Time frame
At hospital discharge up to a year
3

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

Time frame
From hospital admission until hospital discharge up to a year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

Source ClinicalTrials.gov
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