High-Flow Nasal Cannula vs. NIV After Extubation in Children Undergoing Heart Surgery
NCT ID: NCT07059689
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
114 participants
INTERVENTIONAL
2025-06-05
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High Flow Nasal Cannula
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.
High Flow Nasal Cannula (HFNC)
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)
Participants in this arm will receive Non-Invasive Ventilation (NIV) immediately following planned extubation after cardiac surgery, in accordance with institutional protocols.
Non-Invasive Ventilation (NIV)
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
Interventions
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High Flow Nasal Cannula (HFNC)
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)
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Indonesia University
OTHER
Responsible Party
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Yogi Prawira
Head of Pediatric Emergency and Intensive Care Divison
Principal Investigators
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Head of Pediatric Emergency and Intensive Care Divison
Role: PRINCIPAL_INVESTIGATOR
Indonesia University
Locations
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Faculty of Medicine, University of Indonesia
Jakarta, DKI Jakarta, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Head of Pediatric Emergency and Intensive Care Division
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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24-04-0565
Identifier Type: -
Identifier Source: org_study_id
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