- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07353788
Mechanical Power in One-lung Ventilation (POWEROL)
January 19, 2026 updated by: CIGDEM YILDIRIM GUCLU, Ankara University
Postoperative Complications and Outcomes Related to Mechanical Power in One-lung Ventilation- A Multicentre Observational Study
Thoracic surgery usually necessitates one-lung ventilation (OLV) to provide surgical access while maintaining adequate gas exchange.
However, OLV is associated with an increased risk of PPCs , a major cause of morbidity and mortality.
Mechanical power, a composite parameter incorporating tidal volume, respiratory rate, driving pressure, and flow resistance, has been proposed as a key factor influencing ventilator-induced lung injury (VILI) and postoperative outcome.
Understanding the association between mechanical power during OLV and PPCs could provide insights for optimizing intraoperative ventilatory strategies and reducing the burden of PPCs.
As OLV inherently alters normal lung mechanics by decreasing functional residual capacity and introducing inequalities in ventilation-perfusion ratio, the complexity of managing mechanical power becomes even more pronounced.
Under these altered conditions, the risk of PPC-including atelectasis, pneumonia, and respiratory failure-can be significantly elevated.
Factors such as ventilatory settings, lung protection strategies, and the duration of OLV play pivotal roles in influencing mechanical power delivery and thereby impacting lung function recovery post-surgery.
Current literature indicates a correlation between inappropriate mechanical ventilation strategies during OLV and increased incidence of PPCs.
However, there remains a gap in understanding how precisely mechanical power, as a quantifiable measure, influences patient outcomes following OLV.
Therefore, this study aims to investigate the relationship between mechanical power during OLV and the subsequent risk of PPC.
By elucidating these dynamics, the findings may inform clinical practices surrounding OLV management, ultimately improving patient safety and outcomes in thoracic surgery.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: CIGDEM YILDIRIM GUCLU, Prof Dr
- Phone Number: +905324576648
- Email: drcigdemyldrm@yahoo.com.tr
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
hospital
Description
Inclusion Criteria:
- Patients aged 18 years or older,
- ASA physical status I-IV
- All thoracic surgeries
- One lung ventilation period >1 hour
- Patients capable of giving written informed consent
Exclusion Criteria:
1-Patients undergoing cardiac surgery
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of PPCs during the first five postoperative days, defined according to standard criteria
Time Frame: From enrollment to the end of postoperative 5 th day
|
Postoperative pulmonary complications ;(e.g., pneumonia, acute respiratory distress syndrome [ARDS], or prolonged mechanical ventilation).According to StEP-COMPAC group definition [Abbott et al. 2018 Br J Anaesth 2018 May;120(5):1066-1079.]
|
From enrollment to the end of postoperative 5 th day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Threshold mechanical power (J/min)associated with PPCs
Time Frame: From enrollment to postoperative 5 th day
|
From enrollment to postoperative 5 th day
|
|
Unscheduled ICU admission rates
Time Frame: From enrollment to postoperative 5 th day
|
From enrollment to postoperative 5 th day
|
|
Extra-pulmonary postoperative complications(number of complications)
Time Frame: From enrollment to postoperative 5 th day
|
From enrollment to postoperative 5 th day
|
|
Length of ICU stay(day)
Time Frame: up to 5 th day
|
up to 5 th day
|
|
Length of hospital stay(day)
Time Frame: From enrollment to postoperative 5 th day
|
From enrollment to postoperative 5 th day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Estimated)
February 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
December 9, 2025
First Submitted That Met QC Criteria
January 19, 2026
First Posted (Actual)
January 20, 2026
Study Record Updates
Last Update Posted (Actual)
January 20, 2026
Last Update Submitted That Met QC Criteria
January 19, 2026
Last Verified
October 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 15.10.2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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