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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство 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
• Устройство 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

Первичные конечные точки

• Number of Participants Requiring Reintubation Within 48 - 72 Hours Following Planned Extubation After Cardiac Surgery [Срок оценки: 72 hours post-extubation]

Вторичные конечные точки (4)

• Length of Stay in the Cardiac Intensive Care Unit (CICU) [Срок оценки: 1 month]
• Total Duration of Sedation Post-Extubation [Срок оценки: Up to 72 hours post-extubation]
• Total Dosage of Sedation Post-Extubation [Срок оценки: Up to 72 hours post-extubation]
• Change in COMFORT Scale Scores Post-Extubation [Срок оценки: Up to 48 hours post-extubation]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

• Faculty of Medicine, University of Indonesia — Jakarta

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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 francophon PMID 26464393
• 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

Идентификаторы

NCT: NCT07059689 · 24-04-0565

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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