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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
| Total Duration of Sedation Post-Extubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Head of Pediatric Emergency and Intensive Care Divison | Contact | +62811747363 | dr.yogiprawira@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Head of Pediatric Emergency and Intensive Care Divison | Indonesia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, University of Indonesia | Recruiting | Jakarta | DKI Jakarta | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38041510 | Background | 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. | |
| 38389199 | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 2, 2025 | Jun 19, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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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.
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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.
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| 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 |
|
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.
| 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. | 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. | Up to 48 hours post-extubation |
| 38383357 | 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. |
| 26167395 | 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. |
| 24612137 | 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. |
| 29310868 | 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. |
| 26464393 | 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. |
| 32714476 | 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. |
| 34092274 | 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. |
| 32639473 | 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. |
| 33864485 | 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. |
| 32804741 | 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. |
| 30745768 | 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. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |