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NCT Number: NCT07432477

Single-step vs Stepwise Lung Recruitment Maneuvers After Cardiopulmonary Bypass

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.

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Key information

Conditions

Atelectasis, Postoperative Lung Diseases Pulmonary Atelectasis Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Cardiac Index

    Time frame: Intraoperative period

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

Secondary outcomes

  1. The heart rate measurement

    Time frame: Intraoperative period and postoperative day 1.

    Heart rate will be recorded preoperatively; after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation.

  2. The mean arterial pressure measurement

    Time frame: Intraoperative period and postoperative day 1.

    Mean arterial pressure will be recorded preoperatively; after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation.

  3. Systemic vascular resistance index measurement

    Time frame: Intraoperative period and postoperative day 1.

    Systemic vascular resistance index will be recorded preoperatively; after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation.

  4. Stroke volume variation

    Time frame: Intraoperative period and postoperative day 1.

    Dynamic hemodynamic parameters, including stroke volume variation (SVV, %), will be recorded as separate variables using invasive arterial waveform analysis. Measurements will be obtained after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation.

  5. Arterial elastance

    Time frame: Intraoperative period and postoperative day 1.

    Dynamic hemodynamic parameters including arterial elastance (Ea, mmHg/mL), will be recorded as separate variables using invasive arterial waveform analysis. Measurements will be obtained after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation.

  6. Contractility

    Time frame: Intraoperative period and postoperative day 1.

    Dynamic hemodynamic parameters, including cardiac contractility indices, will be recorded as separate variables using invasive arterial waveform analysis. Measurements will be obtained after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation.

  7. Lung ultrasound atelectasis score

    Time frame: Intraoperative period and postoperative day 1

    Change in lung ultrasound atelectasis score before and after the recruitment maneuver. Lung aeration was assessed using a 12-region quantitative lung ultrasound (LUS) score (0-36) based on the ESICM-ESPNIC consensus. Each region was graded 0-3 (0 = normal aeration; 1 = mild loss with B-lines/subpleural changes ≤50%; 2 = moderate loss with coalescent B-lines or small consolidation <2-2.5 cm; 3 = severe loss with large consolidation ≥2-2.5 cm). Higher scores indicated greater aeration loss.

  8. Peak airway pressure

    Time frame: Intraoperative period and postoperative day 1.

    Peak airway pressure (Ppeak), measured in cmH₂O, will be recorded after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation.

  9. Plateau pressure

    Time frame: Intraoperative period and postoperative day 1.

    plateau pressure (Pplat), measured in cmH₂O, will be recorded after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation.

  10. Dynamic lung compliance

    Time frame: Intraoperative period and postoperative day 1.

    Dynamic lung compliance (Cdyn), expressed as mL/cmH₂O, will be recorded after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation.

  11. Driving pressure

    Time frame: Intraoperative period and postoperative day 1.

    Driving pressure, calculated as plateau pressure minus positive end-expiratory pressure (Pplat - PEEP) and expressed in cmH₂O, will be recorded after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation.

  12. Positive end-expiratory pressure

    Time frame: Intraoperative period and postoperative day 1.

    Positive end-expiratory pressure (PEEP), measured in cmH₂O, will be recorded after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation.

  13. Arterial pH

    Time frame: Intraoperative period and postoperative day 1.

    Arterial pH (unitless) measured by arterial blood gas analysis will be recorded after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation.

  14. Partial pressure of arterial oxygen

    Time frame: Intraoperative period and postoperative day 1.

    Partial pressure of arterial oxygen (PaO₂, mmHg) measured by arterial blood gas analysis will be recorded after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation.

  15. Partial pressure of arterial carbon dioxide

    Time frame: Intraoperative period and postoperative day 1.

    Partial pressure of arterial carbon dioxide (PaCO₂, mmHg) measured by arterial blood gas analysis will be recorded after induction; immediately before the recruitment maneuver (RM); during RM at the point of maximum airway pressure; at the end of RM; 30 minutes after RM; at postoperative hour 1; and immediately after extubation.

  16. Serum lactate level

    Time frame: Intraoperative period and postoperative day 1

    Change in serum lactate level measured perioperatively.

  17. Extubation time

    Time frame: Postoperative day 1

    After the operation, the time until the patient is extubated will be recorded.

  18. Length of intensive care unit stay (ICU)

    Time frame: The time from admission to the ICU to the time of discharge to the hospital ward; during the hospital stay, an average of 7 days

    Time from ICU admission to ICU discharge.

Study contacts

Contact information is provided by the study sponsor or research team.

Burhan Dost, MD

CONTACT

[email protected]

+903623121919

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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