Intraoperative Mechanical Power and Ventilation-Associated Lung Injury: Assessing Complications

The Relationship Between Intraoperative Mechanical Power Applied to The Lung and Postoperative Pulmonary Complications in Patients Undergoing Major Abdominal Surgery

This study investigates the relationship between intraoperative mechanical power and postoperative pulmonary complications in patients undergoing major abdominal surgery. The investigators record mechanical ventilation parameters and surgical characteristics, assessing the incidence of pulmonary complications within 24 hours postoperatively."

Study Overview

Detailed Description

Postoperative pulmonary complications (PPCs) are often underestimated yet remain a leading cause of perioperative morbidity and mortality. These complications encompass postoperative hypoxia, atelectasis, bronchospasm, pulmonary infections, infiltrations, aspiration pneumonia, acute respiratory distress syndrome (ARDS), pleural effusion, and pulmonary edema. They are prevalent and associated with significant costs, prolonging hospital stays, ventilation duration, and ICU admissions, while also increasing mortality and morbidity risks.

Perioperative mechanical ventilation stands as a primary risk factor for the development of postoperative pulmonary complications. Approximately one in four patients with normal lungs will develop some form of lung injury following mechanical ventilation, although much of this damage can be mitigated through the use of appropriate ventilation strategies. A range of pulmonary complications induced by mechanical ventilation is known as ventilator-induced lung injury (VILI).

A growing understanding of the injury mechanism aids researchers in identifying risk factors for lung injury, including tidal volume, respiratory rate, pressures, and flow. Mechanical power, which combines tidal volume, respiratory rate, and airway pressure, has been identified as a potential contributor to VILI. The greater the power, the higher the likelihood of lung injury occurring.

Mechanical power represents the total energy expended over a specific period and is typically expressed in joules per minute (J/min). The equation for mechanical power can help estimate the contribution of different causes of VILI and their variations. This equation can be easily applied in the software of each ventilator. Recent studies have investigated threshold values for mechanical power in relation to ventilator-associated lung injury using the simplified formula found for mechanical power

Study Type

Observational

Enrollment (Actual)

207

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey, 06200
        • Ankara Oncology Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consisted of adult patients (aged 18 years and older) scheduled for elective major abdominal surgery.

Description

Inclusion Criteria:

  • Patients aged 18 years and older
  • Patients undergoing elective major abdominal surgery
  • Patients with ASA (American Society of Anesthesiologists) physical status classification I-IV
  • Patients capable of providing voluntary consent

Exclusion Criteria:

  • Patients under 18 years of age
  • Pregnant individuals
  • Those who decline to participate in the study
  • Patients requiring reoperation due to surgical complications
  • Organ transplant recipients
  • Patients who were intubated preoperatively
  • Day surgery patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients who developed postoperative pulmonary complications
This cohort consists of patients who developed postoperative pulmonary complications (PPCs). The cohort of patients developing PPCs includes individuals who experienced postoperative hypoxia, atelectasis, bronchospasm, pulmonary infection, pulmonary infiltration, aspiration pneumonia, acute respiratory distress syndrome, pleural effusion, and pulmonary edema. PPCs were assessed using the European Perioperative Clinical Outcome framework.
The intervention involves the management of mechanical ventilation during major abdominal surgery. This includes the adjustment of ventilation parameters such as tidal volume, respiratory rate, peak pressure, positive end-expiratory pressure (PEEP), and inspiratory flow rate. The aim is to optimize ventilation strategies to reduce the risk of postoperative pulmonary complications
patients who did not develop postoperative pulmonary complications .
This cohort comprises patients who did not develop postoperative pulmonary complications (PPCs). The cohort of patients not developing PPCs includes individuals who did not exhibit significant pulmonary complications postoperatively.
The intervention involves the management of mechanical ventilation during major abdominal surgery. This includes the adjustment of ventilation parameters such as tidal volume, respiratory rate, peak pressure, positive end-expiratory pressure (PEEP), and inspiratory flow rate. The aim is to optimize ventilation strategies to reduce the risk of postoperative pulmonary complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between mechanical power and postoperative pulmonary complications
Time Frame: Patients were followed for 24 hours postoperatively to evaluate the occurrence of pulmonary complications.

This study aimed to assess the association between mechanical power and postoperative pulmonary complications. Mechanical power is a crucial parameter for predicting the risk of lung injury related to mechanical ventilation.

Measurement Tool: Mechanical power calculation based on ventilator parameters. Unit of Measure: Mechanical power expressed in joules per minute (J/min).

Patients were followed for 24 hours postoperatively to evaluate the occurrence of pulmonary complications.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Arif Timuroğlu, ankara oncology trainig and research hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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