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Atelectasis, PostoperativeNCT07432477

Single-step vs Stepwise Lung Recruitment Maneuvers After Cardiopulmonary Bypass

A study testing Single Step Lung Recruitment Maneuver and Stepwise Lung Recruitment Maneuver in people with Atelectasis, Postoperative, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Atelectasis, Postoperative
What is being tested?
Single Step Lung Recruitment Maneuver and Stepwise Lung Recruitment Maneuver
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Feb 2026to 1 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site, 1 recruiting
  • Ondokuz Mayıs University, Faculty of Medicine

    Samsun

    Burhan Dost, MD, +903623121919, burhandost@hotmail.com

    Hilal H Kandemir, MD, +903623121919, hhilal.kandemir@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Single Step Lung Recruitment Maneuver, Stepwise Lung Recruitment Maneuver
Keywords
cardiopulmonary bypass, lung recruitment maneuver, atelectasis, cardiac surgery, cardiac index, hemodynamics, lung ultrasound, positive end-expiratory pressure
Medical subject headings
Pulmonary Atelectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single Step Lung Recruitment ManeuverProcedure or surgery

    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 ManeuverProcedure or surgery

    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.

Study groups in NCT07432477
Study groupRoleWhat they receive
Grup Single StepActive comparatorA single step lung recruitment maneuver for 30 seconds will be applied
Receives: Procedure: Single Step Lung Recruitment Maneuver
Grup StepwiseActive comparatorA stepwise recruitment maneuver will be applied.
Receives: Procedure: Stepwise Lung Recruitment Maneuver

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Cardiac Index

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

    Measured: Intraoperative period

Secondary outcomes (18)
  1. The heart rate measurement

    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.

    Measured: Intraoperative period and postoperative day 1.

  2. The mean arterial pressure measurement

    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.

    Measured: Intraoperative period and postoperative day 1.

  3. Systemic vascular resistance index measurement

    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.

    Measured: Intraoperative period and postoperative day 1.

  4. Stroke volume variation

    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.

    Measured: Intraoperative period and postoperative day 1.

  5. Arterial elastance

    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.

    Measured: Intraoperative period and postoperative day 1.

  6. Contractility

    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.

    Measured: Intraoperative period and postoperative day 1.

  7. Lung ultrasound atelectasis score

    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.

    Measured: Intraoperative period and postoperative day 1

  8. Peak airway pressure

    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.

    Measured: Intraoperative period and postoperative day 1.

  9. Plateau pressure

    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.

    Measured: Intraoperative period and postoperative day 1.

  10. Dynamic lung compliance

    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.

    Measured: Intraoperative period and postoperative day 1.

  11. Driving pressure

    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.

    Measured: Intraoperative period and postoperative day 1.

  12. Positive end-expiratory pressure

    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.

    Measured: Intraoperative period and postoperative day 1.

  13. Arterial pH

    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.

    Measured: Intraoperative period and postoperative day 1.

  14. Partial pressure of arterial oxygen

    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.

    Measured: Intraoperative period and postoperative day 1.

  15. Partial pressure of arterial carbon dioxide

    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.

    Measured: Intraoperative period and postoperative day 1.

  16. Serum lactate level

    Change in serum lactate level measured perioperatively.

    Measured: Intraoperative period and postoperative day 1

  17. Extubation time

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

    Measured: Postoperative day 1

  18. Length of intensive care unit stay (ICU)

    Time from ICU admission to ICU discharge.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2026
  2. Study start15 Feb 2026
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07432477
Sponsor's protocol ID
LRMCPB000
Status last verified
Jun 2026
First submitted
26 Jan 2026
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

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

    PubMed 40353867

Questions about this trial

What is this clinical trial studying?

A study testing Single Step Lung Recruitment Maneuver and Stepwise Lung Recruitment Maneuver in people with Atelectasis, Postoperative, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Burhan Dost, MD (+903623121919, burhandost@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cardiac Index (time frame: Intraoperative period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07432477, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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