Cardiopulmonary Bypass on Mechanical Power and Postoperative Pulmonary Complications

The Impact of Two Different Mechanical Ventilation Strategies During Cardiopulmonary Bypass on Mechanical Power and Postoperative Pulmonary Complications

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pneumonia; Pneumothorax; Respiratory Failure; Ards; Postoperative Pulmonary Atelectasis
• Intervention / Treatment: Other: mechanical power calculation

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

İnclusion 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mechanical power	mechanical power=0.098*minute ventilation *(Ppeak-0.5*(Pplato-PEEP)	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mechanical power	mechanical power=0.098*minute ventilation *(Ppeak-0.5*(Pplato-PEEP)	postoperative in intensive care unit

Collaborators and Investigators

• Sponsor: TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): January 15, 2025
• Study Completion (Estimated): April 25, 2025

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Estimated): March 5, 2024

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Pleural Diseases; Pneumothorax; Pulmonary Atelectasis; Respiratory Insufficiency
• Other Study ID Numbers: 2023/462

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No