- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06375980
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey, 06200
- Ankara Oncology Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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
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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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Relationship between mechanical power and postoperative pulmonary complications
Time Frame: Patients were followed for 24 hours postoperatively to evaluate the occurrence of pulmonary complications.
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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.
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Collaborators and Investigators
Investigators
- Study Director: Arif Timuroğlu, ankara oncology trainig and research hospital
Publications and helpful links
General Publications
- Khan NA, Quan H, Bugar JM, Lemaire JB, Brant R, Ghali WA. Association of postoperative complications with hospital costs and length of stay in a tertiary care center. J Gen Intern Med. 2006 Feb;21(2):177-80. doi: 10.1111/j.1525-1497.2006.00319.x.
- Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.
- Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.
- Patel K, Hadian F, Ali A, Broadley G, Evans K, Horder C, Johnstone M, Langlands F, Matthews J, Narayan P, Rallon P, Roberts C, Shah S, Vohra R. Postoperative pulmonary complications following major elective abdominal surgery: a cohort study. Perioper Med (Lond). 2016 May 23;5:10. doi: 10.1186/s13741-016-0037-0. eCollection 2016.
- Senturk E, Ugur S, Celik Y, Cukurova Z, Asar S, Cakar N. The power of mechanical ventilation may predict mortality in critically ill patients. Minerva Anestesiol. 2023 Jul-Aug;89(7-8):663-670. doi: 10.23736/S0375-9393.23.17080-5. Epub 2023 Apr 20.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANKARA_OR_MP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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