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

NCT07059689 | Recruiting

• 1 other identifier: 24-04-0565
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Defects, Congenital; Intensive Care Units, Pediatric; Respiration, Artificial; Extubation

Outcome Measures

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.

  72 hours post-extubation

Secondary Outcomes (4)

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

  1 month

• Total Duration of Sedation Post-Extubation

  Up to 72 hours post-extubation

• Total Dosage of Sedation Post-Extubation

  Up to 72 hours post-extubation

• Change in COMFORT Scale Scores Post-Extubation

  Up to 48 hours post-extubation

Study Arms (2)

High Flow Nasal Cannula

EXPERIMENTAL

Participants in this arm will receive High Flow Nasal Cannula (HFNC) therapy using the Airvo™3 Nasal High Flow System immediately following planned extubation after cardiac surgery.

Device: High Flow Nasal Cannula (HFNC)

Non-Invasive Ventilation (NIV)

ACTIVE COMPARATOR

Participants in this arm will receive Non-Invasive Ventilation (NIV) immediately following planned extubation after cardiac surgery, in accordance with institutional protocols.

Device: Non-Invasive Ventilation (NIV)

Interventions

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

High Flow Nasal Cannula

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

Non-Invasive Ventilation (NIV)

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Faculty of Medicine, University of Indonesia

Jakarta, DKI Jakarta, 10430, Indonesia

RECRUITING

Related Publications (13)

• Kuitunen I, Uimonen M. Noninvasive respiratory support preventing reintubation after pediatric cardiac surgery-A systematic review. Paediatr Anaesth. 2024 Mar;34(3):204-211. doi: 10.1111/pan.14808. Epub 2023 Dec 1.

  PMID: 38041510 BACKGROUND

• Elmitwalli I, Abdelhady E, Kalsotra S, Gehred A, Tobias JD, Olbrecht VA. Use of high-flow nasal cannula versus other noninvasive ventilation techniques or conventional oxygen therapy for respiratory support following pediatric cardiac surgery: A systematic review and meta-analysis. Paediatr Anaesth. 2024 Jun;34(6):519-531. doi: 10.1111/pan.14866. Epub 2024 Feb 22.

  PMID: 38389199 BACKGROUND

• Zhou SJ, Chen XH, Liu YY, Chen Q, Zheng YR, Zhang QL. Comparison of high-flow nasal cannula oxygenation and non-invasive ventilation for postoperative pediatric cardiac surgery: a meta-analysis. BMC Pulm Med. 2024 Feb 21;24(1):92. doi: 10.1186/s12890-024-02901-5.

  PMID: 38383357 BACKGROUND

• McQueen M, Rojas J, Sun SC, Tero R, Ives K, Bednarek F, Owens L, Dysart K, Dungan G, Shaffer TH, Miller TL. Safety and Long Term Outcomes with High Flow Nasal Cannula Therapy in Neonatology: A Large Retrospective Cohort Study. J Pulm Respir Med. 2014 Dec;4(6):216. doi: 10.4172/2161-105X.1000216.

  PMID: 26167395 BACKGROUND

• Mayfield S, Bogossian F, O'Malley L, Schibler A. High-flow nasal cannula oxygen therapy for infants with bronchiolitis: pilot study. J Paediatr Child Health. 2014 May;50(5):373-8. doi: 10.1111/jpc.12509. Epub 2014 Feb 25.

  PMID: 24612137 BACKGROUND

• Doshi P, Whittle JS, Bublewicz M, Kearney J, Ashe T, Graham R, Salazar S, Ellis TW Jr, Maynard D, Dennis R, Tillotson A, Hill M, Granado M, Gordon N, Dunlap C, Spivey S, Miller TL. High-Velocity Nasal Insufflation in the Treatment of Respiratory Failure: A Randomized Clinical Trial. Ann Emerg Med. 2018 Jul;72(1):73-83.e5. doi: 10.1016/j.annemergmed.2017.12.006. Epub 2018 Jan 6.

  PMID: 29310868 BACKGROUND

• Demoule A, Chevret S, Carlucci A, Kouatchet A, Jaber S, Meziani F, Schmidt M, Schnell D, Clergue C, Aboab J, Rabbat A, Eon B, Guerin C, Georges H, Zuber B, Dellamonica J, Das V, Cousson J, Perez D, Brochard L, Azoulay E; oVNI Study Group; REVA Network (Research Network in Mechanical Ventilation). Changing use of noninvasive ventilation in critically ill patients: trends over 15 years in francophone countries. Intensive Care Med. 2016 Jan;42(1):82-92. doi: 10.1007/s00134-015-4087-4. Epub 2015 Oct 13.

  PMID: 26464393 BACKGROUND

• Chang CJ, Chiang LL, Chen KY, Feng PH, Su CL, Hsu HS. High-Flow Nasal Cannula versus Noninvasive Positive Pressure Ventilation in Patients with Heart Failure after Extubation: An Observational Cohort Study. Can Respir J. 2020 Jul 3;2020:6736475. doi: 10.1155/2020/6736475. eCollection 2020.

  PMID: 32714476 BACKGROUND

• Simeonov L, Pechilkov D, Kaneva A, McLellan MC, Jenkins K. Early extubation strategy after congenital heart surgery: 1-year single-centre experience. Cardiol Young. 2022 Mar;32(3):357-363. doi: 10.1017/S1047951121002067. Epub 2021 Jun 7.

  PMID: 34092274 BACKGROUND

• Rooney SR, Mastropietro CW, Benneyworth B, Graham EM, Klugman D, Costello J, Ghanayem N, Zhang W, Banerjee M, Gaies M. Influence of Early Extubation Location on Outcomes Following Pediatric Cardiac Surgery. Pediatr Crit Care Med. 2020 Oct;21(10):e915-e921. doi: 10.1097/PCC.0000000000002452.

  PMID: 32639473 BACKGROUND

• Miura S, Butt W, Thompson J, Namachivayam SP. Recurrent Extubation Failure Following Neonatal Cardiac Surgery Is Associated with Increased Mortality. Pediatr Cardiol. 2021 Jun;42(5):1149-1156. doi: 10.1007/s00246-021-02593-2. Epub 2021 Apr 17.

  PMID: 33864485 BACKGROUND

• Miura S, Jardim PV, Butt W, Namachivayam SP. Extubation Failure and Major Adverse Events Secondary to Extubation Failure Following Neonatal Cardiac Surgery. Pediatr Crit Care Med. 2020 Dec;21(12):e1119-e1125. doi: 10.1097/PCC.0000000000002470.

  PMID: 32804741 BACKGROUND

• Murni IK, Djer MM, Yanuarso PB, Putra ST, Advani N, Rachmat J, Perdana A, Sukardi R. Outcome of pediatric cardiac surgery and predictors of major complication in a developing country. Ann Pediatr Cardiol. 2019 Jan-Apr;12(1):38-44. doi: 10.4103/apc.APC_146_17.

  PMID: 30745768 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital; Respiratory Aspiration

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Head of Pediatric Emergency and Intensive Care Divison

  Indonesia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Head of Pediatric Emergency and Intensive Care Divison

CONTACT

+62811747363; dr.yogiprawira@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pediatric Emergency and Intensive Care Divison

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 11, 2025
• Study Start: June 5, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

ID (1)