High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorIndonesia University
About this trial
High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients under 18 years of age.
Post-cardiac surgery patients in the CICU of Cipto Mangunkusumo National General Hospital
Patients at high risk of extubation failure (e.g., young age, open sternotomy, mechanical ventilation >48 hours).
Patients who pass the extubation readiness test and spontaneous breathing trial.
Disqualifiers
Diaphragmatic paralysis.
Decreased consciousness.
Neuromuscular disease.
Pneumothorax without drainage.
Trial design
Design model
Parallel
Treatments tested in this trial
High Flow Nasal Cannula (HFNC)
DeviceParticipants in this arm will receive High Flow Nasal Cannula therapy using the Airvo™3 Nasal High Flow System immediately after planned extubation following cardiac surgery
Non-Invasive Ventilation (NIV)
DeviceParticipants in this arm will receive Non-Invasive Ventilation (NIV) immediately after planned extubation following cardiac surgery. NIV will be delivered using standard ICU ventilator settings, with parameters tailored to each patient's clinical condition
Treatment groups
114 Participants
are divided into 2 treatment groupsGroup A: High Flow Nasal CannulaExperimental treatment 1 intervention
Group B: Non-Invasive Ventilation (NIV)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants Requiring Reintubation Within 48 - 72 Hours Following Planned Extubation After Cardiac Surgery
Participants who require reintubation due to respiratory failure, clinical deterioration, or complications related to respiratory support will be recorded. This outcome will be compared between the HFNC and NIV groups to assess extubation success.
Time frame
72 hours post-extubationSecondary outcomes
1
Length of Stay in the Cardiac Intensive Care Unit (CICU)
The total number of days each participant remains in the CICU will be recorded and compared between the HFNC and NIV groups.
Time frame
1 month2
Total Duration of Sedation Post-Extubation
The cumulative duration (in hours) of sedative medication administration following extubation, measured up to 72 hours post-extubation. Duration will be compared between the HFNC and NIV groups.
Time frame
Up to 72 hours post-extubation3
Total Dosage of Sedation Post-Extubation
The cumulative total dose (in milligrams) of sedative medications administered following extubation, measured up to 72 hours post-extubation. Dosage will be compared between the HFNC and NIV groups.
Time frame
Up to 72 hours post-extubation4
Change in COMFORT Scale Scores Post-Extubation
The COMFORT Behavioral Scale will be used to assess patient comfort and distress levels at 0, 6, 12, 18, 24, 30, 36, 42, and 48 hours post-extubation. This scale includes multiple behavioral indicators such as alertness, agitation, crying, physical movement, muscle tone, and facial tension. Scores range from 6 to 30, where higher scores indicate greater distress and lower scores indicate better comfort/sedation.
Time frame
Up to 48 hours post-extubationSponsors and contacts
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Source ClinicalTrials.gov