Single-step vs Stepwise Lung Recruitment Maneuvers After Cardiopulmonary Bypass

Официальное название

Comparison of Hemodynamic and Pulmonary Outcomes Between Single-Step and Stepwise Lung Recruitment Maneuvers After Cardiopulmonary Bypass: A Randomized Controlled Trial

Обзор

This prospective randomized controlled trial aims to compare the hemodynamic and pulmonary effects of single-step and stepwise lung recruitment maneuvers in adult patients undergoing elective cardiac surgery with cardiopulmonary bypass. After separation from cardiopulmonary bypass, patients will be randomized to receive either a single-step sustained inflation recruitment maneuver or a stepwise incremental recruitment maneuver, both combined with 8 cmH₂O positive end-expiratory pressure. The primary outcome is the change in cardiac index before and after the recruitment maneuver. Secondary outcomes include lung ultrasound atelectasis score, and hemodynamic parameters.

Подробное описание

Atelectasis frequently develops after cardiopulmonary bypass due to lung ischemia-reperfusion injury, inflammatory response, and mechanical factors related to cardiac surgery. Lung recruitment maneuvers are commonly used to improve lung aeration and oxygenation; however, increased intrathoracic pressure during recruitment may negatively affect venous return and cardiac output.

In this randomized controlled trial, adult patients undergoing elective open-heart surgery with cardiopulmonary bypass will be allocated to receive either a single-step sustained inflation recruitment maneuver or a stepwise incremental recruitment maneuver, both combined with 8 cmH₂O positive end-expiratory pressure after separation from cardiopulmonary bypass. Hemodynamic variables, particularly cardiac index, will be assessed before and after recruitment. Pulmonary effects will be evaluated using lung ultrasound atelectasis scoring and arterial blood gas analysis. The study aims to identify the recruitment strategy that provides optimal pulmonary benefits while preserving hemodynamic stability in this high-risk patient population.

Вмешательства

• Процедура Single Step Lung Recruitment Maneuver
  A sustained inflation lung recruitment maneuver with an airway pressure of 30 cmH₂O applied for 30 seconds after separation from cardiopulmonary bypass, combined with 8 cmH₂O positive end-expiratory pressure.
• Процедура Stepwise Lung Recruitment Maneuver
  A stepwise lung recruitment maneuver in which airway pressure is increased by 5 cmH₂O every 5 seconds up to 30 cmH₂O and then decreased in the same manner after separation from cardiopulmonary bypass, combined with 8 cmH₂O positive end-expiratory pressure.

Первичные конечные точки

• Change in Cardiac Index [Срок оценки: Intraoperative period]

Вторичные конечные точки (12)

• The heart rate measurement [Срок оценки: Intraoperative period and postoperative day 1.]
• The mean arterial pressure measurement [Срок оценки: Intraoperative period and postoperative day 1.]
• Systemic vascular resistance index measurement [Срок оценки: Intraoperative period and postoperative day 1.]
• Stroke volume variation [Срок оценки: Intraoperative period and postoperative day 1.]
• Arterial elastance [Срок оценки: Intraoperative period and postoperative day 1.]
• Contractility [Срок оценки: Intraoperative period and postoperative day 1.]
• Lung ultrasound atelectasis score [Срок оценки: Intraoperative period and postoperative day 1]
• Peak airway pressure [Срок оценки: Intraoperative period and postoperative day 1.]
• Plateau pressure [Срок оценки: Intraoperative period and postoperative day 1.]
• Dynamic lung compliance [Срок оценки: Intraoperative period and postoperative day 1.]
• Driving pressure [Срок оценки: Intraoperative period and postoperative day 1.]
• Positive end-expiratory pressure [Срок оценки: Intraoperative period and postoperative day 1.]

Критерии участия

Критерии включения

• Age 18-80 years
• ASA (American Society of Anesthesiologists) II-IV
• Patients undergoing elective cardiac surgery (coronary artery bypass grafting, mitral valve replacement, aortic valve replacement)

Критерии исключения

• Emergency surgery
• Presence of perioperative arrhythmia
• <35% left ventricular ejection fraction
• >50 mmHg systolic pulmonary artery pressure
• Known chronic obstructive pulmonary disease or interstitial lung disease
• Pneumothorax
• Mean arterial pressure <60 mmHg during recruitment maneuver
• New York Heart Association (NYHA) class III-IV heart failure
• Advanced cardiomyopathy or severe mitral regurgitation
• Cross-clamp time longer than 2 hours
• Requirement for high-dose inotropic or vasopressor support
• Patients who cannot be extubated after postoperative 24 hours

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Ondokuz Mayıs University, Faculty of Medicine — Samsun

Публикации

• Longo S, Siri J, Acosta C, Palencia A, Echegaray A, Chiotti I, Parisi A, Ricci L, Natal M, Suarez-Sipmann F, Tusman G. Lung recruitment improves right ventricular performance after cardiopulmonary bypass: A randomised controlled trial. Eur J Anaesthesiol. 2017 Feb;34(2):66-74. doi: 10.1097/EJA.0000000000000559. PMID 27861261
• Celebi S, Koner O, Menda F, Korkut K, Suzer K, Cakar N. The pulmonary and hemodynamic effects of two different recruitment maneuvers after cardiac surgery. Anesth Analg. 2007 Feb;104(2):384-90. doi: 10.1213/01.ane.0000252967.33414.44. PMID 17242096
• Myatra SN. Hemodynamic effects of alveolar recruitment maneuvres in the operating room: Proceed with caution. J Anaesthesiol Clin Pharmacol. 2019 Oct-Dec;35(4):431-433. doi: 10.4103/joacp.JOACP_223_19. No abstract available. PMID 31920224
• Nielsen J, Ostergaard M, Kjaergaard J, Tingleff J, Berthelsen PG, Nygard E, Larsson A. Lung recruitment maneuver depresses central hemodynamics in patients following cardiac surgery. Intensive Care Med. 2005 Sep;31(9):1189-94. doi: 10.1007/s00134-005-2732-z. Epub 2005 Aug 12. PMID 16096751
• Mongodi S, Cortegiani A, Alonso-Ojembarrena A, Biasucci DG, Bos LDJ, Bouhemad B, Cantinotti M, Ciuca I, Corradi F, Girard M, Gregorio-Hernandez R, Gualano MR, Mojoli F, Ntoumenopoulos G, Pisani L, Raimondi F, Rodriguez-Fanjul J, Savoia M, Smit MR, Tuinman PR, Zieleskiewicz L, De Luca D. ESICM-ESPNIC international expert consensus on quantitative lung ultrasound in intensive care. Intensive Care Me PMID 40353867

Идентификаторы

NCT: NCT07432477 · LRMCPB000

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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