Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07432477

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

Led by Ondokuz Mayıs University · Updated on 2026-04-06

52

Participants Needed

1

Research Sites

12 weeks

Total Duration

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AI-Summary

What this Trial Is About

This research aims to compare the effects on heart and lung function of two different lung recruitment methods in adults undergoing planned heart surgery with cardiopulmonary bypass. The study focuses on how these methods influence cardiac output and lung aeration after surgery, as lung complications often arise due to surgery-related factors like lung injury and inflammation. The goal is to find the best recruitment technique that improves lungs without harming heart function in this high-risk group. Participants will be randomly assigned after heart-lung machine separation to receive either a single-step sustained inflation lung recruitment maneuver or a stepwise incremental recruitment maneuver. Both methods are combined with a constant positive pressure to keep airways open. The single-step involves holding a set airway pressure for 30 seconds, while the stepwise gradually increases and then decreases airway pressure in stages. These maneuvers occur during the surgery's intraoperative period. Throughout the study, heart and lung function will be closely monitored before and after the lung recruitment. Measurements include cardiac index, heart rate, blood pressure, lung ultrasound scores, blood gases, and various lung mechanics parameters. Participants' recovery times, such as time to breathing tube removal and ICU stay length, will also be recorded. Monitoring continues into the first day after surgery to capture ongoing effects and safety outcomes.

CONDITIONS

Brief Title

Single-step vs Stepwise Lung Recruitment Maneuvers After Cardiopulmonary Bypass

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-80 years
  • ASA physical status II to IV
  • Scheduled for elective cardiac surgery such as coronary artery bypass grafting, mitral valve replacement, or aortic valve replacement
Not Eligible

You will not qualify if you...

  • Emergency surgery
  • Perioperative arrhythmia
  • Left ventricular ejection fraction less than 35%
  • Systolic pulmonary artery pressure greater than 50 mmHg
  • Known chronic obstructive pulmonary disease or interstitial lung disease
  • Pneumothorax
  • Mean arterial pressure less than 60 mmHg during recruitment maneuver
  • New York Heart Association class III or IV heart failure
  • Advanced cardiomyopathy or severe mitral regurgitation
  • Cross-clamp time longer than 2 hours
  • Need for high-dose inotropic or vasopressor support
  • Unable to be extubated within 24 hours after surgery

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgical procedure day

Participants undergo elective open-heart surgery with cardiopulmonary bypass. After separation from cardiopulmonary bypass, participants receive either a single-step sustained inflation lung recruitment maneuver or a stepwise incremental lung recruitment maneuver, both combined with positive end-expiratory pressure.

1 intraoperative treatment session

Post-operative Follow-up

Duration - Up to 7 days during hospital stay

Participants are monitored after surgery for hemodynamic stability and pulmonary function, including lung ultrasound and arterial blood gas analysis.

Daily assessments including postoperative day 1 and ICU stay monitoring

Trial Site Locations

Total: 1 location

1

Ondokuz Mayıs University, Faculty of Medicine

Samsun, Atakum, Turkey (Türkiye), 55270

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Research Team

B

Burhan Dost, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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