Single-step vs Stepwise Lung Recruitment Maneuvers After Cardiopulmonary Bypass

NCT07432477 | Recruiting

• 1 other identifier: LRMCPB000
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atelectasis, Postoperative

Keywords

cardiopulmonary bypass; lung recruitment maneuver; atelectasis; cardiac surgery; cardiac index; hemodynamics; lung ultrasound; positive end-expiratory pressure

Outcome Measures

Primary Outcomes (1)

• Change in Cardiac Index

  Difference in cardiac index measured before and after the lung recruitment maneuver.

  Intraoperative period

Secondary Outcomes (18)

• The heart rate measurement

  Intraoperative period and postoperative day 1.

• The mean arterial pressure measurement

  Intraoperative period and postoperative day 1.

• Systemic vascular resistance index measurement

  Intraoperative period and postoperative day 1.

• Stroke volume variation

  Intraoperative period and postoperative day 1.

• Arterial elastance

  Intraoperative period and postoperative day 1.

Study Arms (2)

Grup Single Step

ACTIVE COMPARATOR

A single step lung recruitment maneuver for 30 seconds will be applied

Procedure: Single Step Lung Recruitment Maneuver

Grup Stepwise

ACTIVE COMPARATOR

A stepwise recruitment maneuver will be applied.

Procedure: Stepwise Lung Recruitment Maneuver

Interventions

Single Step Lung Recruitment Maneuver PROCEDURE

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.

Grup Single Step

Stepwise Lung Recruitment Maneuver PROCEDURE

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.

Grup Stepwise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University, Faculty of Medicine

Samsun, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 Med. 2025 Jun;51(6):1022-1049. doi: 10.1007/s00134-025-07932-y. Epub 2025 May 12.

  PMID: 40353867 BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Burhan Dost, MD

CONTACT

+903623121919; burhandost@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both the patients and the clinicians involved in perioperative management are blinded to group allocation. Outcome assessment and data analysis are performed by an investigator who is also blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: Participants will be randomized in a 1:1 ratio to receive either a single-step sustained inflation lung recruitment maneuver or a stepwise incremental lung recruitment maneuver after separation from cardiopulmonary bypass.

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 25, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

TU (1)