Cardiopulmonary Bypass on Mechanical Power and Postoperative Pulmonary Complications

NCT ID: NCT06292767

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2025-04-25

Brief Summary

During cardiopulmonary bypass (CPB), oxygenation of the patient on the pump can be left completely under pump control, or the lungs can be ventilated with low tidal volume to reduce atelectasis. In recent years, the concept of mechanical power has been used to determine the extent of ventilator-related lung damage. This concept of mechanical power, by which the energy transferred by the ventilator to the lungs can be calculated, will be measured at certain intervals in CPB surgery patients on the pump and compared between the two groups. The investigators aimed to investigate the effect of two different ventilation methods on mechanical power and its relationship with postoperative pulmonary complications.

Detailed Description

Patients will be taken to the operating table after preoperative evaluation. Routine monitoring and routine anesthesia method will be applied to the patient. Access will be made through the radial artery for arterial catheterization. Patients will be ventilated with 6-8 ml/kg tidal volume, 12-14 frequency/min, 5 Positive end expiratory pressure(PEEP), 60% Fraction of inspired oxygen(FiO2) and oxygen saturation over 94. End tidal Carbon dixide(CO2) will be kept in the range of 32-37. After cardiac catheterizations are performed, the pump will be entered, and after all preparations are completed, an aortic cross-clamp will be placed and cardioplegic solution will be sent. After the patient enters the pump at full flow; Group 1: Non-ventilated patient group. Here, patients will be placed in the cardiac bypass mode of the anesthesia machine. Only 150 ml of free air flow will be provided and mechanical ventilation will be turned off.

Group 2: Patients will continue to be ventilated at FiO2: 40%, TV: 3 ml/kg, frequency 12 breaths/min, peep: 5 cm/H2O.

Conditions

Postoperative Pulmonary Atelectasis; Pneumothorax; Pneumonia; Ards; Respiratory Failure

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Not ventilated

Non-ventilated patient group.Patients will be placed in the cardiac bypass mode of the anesthesia machine. Only 150 ml of free air flow will be provided and mechanical ventilation will be turned off.

mechanical power calculation

Intervention Type: OTHER

Mechanical Power= 0.098×Minute ventilation× (peak pressure - 0.5 (plato pressure-PEEP)). These parameters are monitored on the monitor while the patient is mechanically ventilated and placed into the equation

Ventilated

Patients will continue to be ventilated at Fraction of inspired oxygen(FiO2): 40%, Tidal volume(TV): 3 ml/kg, frequency 12 breaths/min, Positive end expiratory pressure (Peep): 5 cm/H2O.

mechanical power calculation

Intervention Type: OTHER

Mechanical Power= 0.098×Minute ventilation× (peak pressure - 0.5 (plato pressure-PEEP)). These parameters are monitored on the monitor while the patient is mechanically ventilated and placed into the equation

Interventions

mechanical power calculation

Mechanical Power= 0.098×Minute ventilation× (peak pressure - 0.5 (plato pressure-PEEP)). These parameters are monitored on the monitor while the patient is mechanically ventilated and placed into the equation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients who will undergo elective cardiopulmonary bypass surgery and agree to participate in the study
• Patients who will undergo coronary or valve surgery
• Surgeries performed on a stopped heart
• Patients over 18 years

Exclusion Criteria

• Patients undergoing emergency cardiac surgery
• Patients who will undergo redo surgery
• Patients who will undergo total circulatory arrest surgery
• Patients in a state of preoperative shock
• Patients with acute and chronic hypoxemia (PaO2 <65mmHg, SpO2 <95 in room air)
• Patients followed with mechanical ventilation for 7 days before surgery
• Patients with BMI>35
• Patients with obstructive sleep apnea syndrome
• Patients with pulmonary artery pressure >50 mmHg
• Patients with glomerular filtration rate <30 ml/min

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Gamze Talih

CLINICAL PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erciyes University

Kayseri, Kayseri, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023/462

Identifier Type: -

Identifier Source: org_study_id