Single-step vs Stepwise Lung Recruitment Maneuvers After Cardiopulmonary Bypass

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Procedure 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.
• Procedure 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.

Primary outcome measures

• Change in Cardiac Index [Time frame: Intraoperative period]

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Ondokuz Mayıs University, Faculty of Medicine — Samsun

Publications

• 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

Identifiers

NCT: NCT07432477 · LRMCPB000

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗