Cardiopulmonary Bypass on Mechanical Power and Postoperative Pulmonary Complications

NCT06292767 | Completed

• 1 other identifier: 2023/462
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• mechanical power

  mechanical power=0.098\*minute ventilation \*(Ppeak-0.5\*(Pplato-PEEP)

  intraoperative

Secondary Outcomes (1)

• mechanical power

  postoperative in intensive care unit

Study Arms (2)

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.

Other: mechanical power calculation

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.

Other: mechanical power calculation

Interventions

mechanical power calculation 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

Not ventilated; Ventilated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are over 18 years and agree to participate in the study.

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Atelectasis; Pneumothorax; Pneumonia; Acute Lung Injury; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pleural Diseases; Respiratory Tract Infections; Infections; Lung Injury; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CLINICAL PROFESSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: March 5, 2024
• Study Start: March 15, 2024
• Primary Completion: January 15, 2025
• Study Completion: April 25, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)