High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery
This study aims to compare the extubation success rate between the use of High Flow Nasal Cannula (HFNC) and Non-Invasive Ventilation (NIV) in pediatric patients post-cardiac surgery at the Cipto Mangunkusumo National General Hospital. Additionally, this study seeks to identify factors influencing extubation failure in high-risk patient populations, compare CICU length of stay, sedation usage and COMFORT scale between patients receiving HFNC and those receiving NIV.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Participants 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
Participants 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
Faculty of Medicine, University of Indonesia
Jakarta, DKI Jakarta, Indonesia
RECRUITINGNumber 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-extubation
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 month
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-extubation
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-extubation
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-extubation
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