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NCT Number: NCT07059689

High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery

High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery

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Key information

Conditions

Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Extubation Heart Diseases Intensive Care Units, Pediatric Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiration, Artificial Respiratory Aspiration Respiratory Tract Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, University of Indonesia

Jakarta, DKI Jakarta, 10430, Indonesia

Location status: Recruiting

Location contact

Head of Pediatric Emergency and Intensive Care Division

CONTACT

[email protected]

+62811747363

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High flow nasal cannula (HFNC)

Device

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

Non-invasive ventilation (NIV)

Device

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

Primary outcomes

  1. Number of Participants Requiring Reintubation Within 48 - 72 Hours Following Planned Extubation After Cardiac Surgery

    Time frame: 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 outcomes

  1. Length of Stay in the Cardiac Intensive Care Unit (CICU)

    Time frame: 1 month

    The total number of days each participant remains in the CICU will be recorded and compared between the HFNC and NIV groups.

  2. Total Duration of Sedation Post-Extubation

    Time frame: 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.

  3. Total Dosage of Sedation Post-Extubation

    Time frame: 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.

  4. Change in COMFORT Scale Scores Post-Extubation

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Head of Pediatric Emergency and Intensive Care Divison

CONTACT

[email protected]

+62811747363

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

High Flow Nasal Cannula vs. Non-Invasive Ventilation in Post-Extubation Pediatric Cardiac Surgery Patients: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 11, 2025
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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