Heart Defects, Congenital, Intensive Care Units, Pediatric, Respiration, Artificial, Extubation
Conditions
Brief summary
High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery
Detailed description
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.
Interventions
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
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study. Due to the visible and functional differences between High Flow Nasal Cannula (HFNC) and Non-Invasive Ventilation (NIV), masking of participants, care providers, investigators, and outcomes assessors is not feasible.
Intervention model description
This is a parallel-group randomized controlled trial involving two intervention arms. Pediatric patients post-cardiac surgery admitted to the Cardiac Intensive Care Unit (CICU) at Cipto Mangunkusumo National General Hospital will be randomly assigned in a 1:1 ratio to receive either High Flow Nasal Cannula (HFNC) therapy or Non-Invasive Ventilation (NIV) for post-extubation respiratory support. Each participant will receive only one type of intervention throughout the study.
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Diaphragmatic paralysis. * Decreased consciousness. * Neuromuscular disease. * Pneumothorax without drainage. * Airway obstruction. * Patients with a tracheostomy. * Unplanned extubation. * Patient received PEEP (Positive End-Expiratory Pressure) \>7 prior to extubation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Requiring Reintubation Within 48 - 72 Hours Following Planned Extubation After Cardiac Surgery | 72 hours post-extubation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay in the Cardiac Intensive Care Unit (CICU) | 1 month | The total number of days each participant remains in the CICU will be recorded and compared between the HFNC and NIV groups. |
| Total Duration of Sedation Post-Extubation | Up to 72 hours 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. |
| Total Dosage of Sedation Post-Extubation | Up to 72 hours 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. |
| Change in COMFORT Scale Scores Post-Extubation | Up to 48 hours 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. |
Countries
Indonesia
Contacts
Primary ContactHead of Pediatric Emergency and Intensive Care Divison
Outcome results
None listed