Thoracic AnesthesiaPOWEROLNCT07353788
Mechanical Power in One-lung Ventilation
An observational study of Thoracic Anesthesia and Thoracotomy Surgery, run by Ankara University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Anesthesia, Thoracotomy Surgery
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hospital
Who may be able to join
- 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
Who cannot join
- 1-Patients undergoing cardiac surgery
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Thoracic Anesthesia, Thoracotomy Surgery
- Keywords
- one lung ventilation, mechanical power, postoperative pulmonary complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of PPCs during the first five postoperative days, defined according to standard criteria
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.]
Measured: From enrollment to the end of postoperative 5 th day
Secondary outcomes (5)
Threshold mechanical power (J/min)associated with PPCs
Measured: From enrollment to postoperative 5 th day
Unscheduled ICU admission rates
Measured: From enrollment to postoperative 5 th day
Extra-pulmonary postoperative complications(number of complications)
Measured: From enrollment to postoperative 5 th day
Length of ICU stay(day)
Measured: up to 5 th day
Length of hospital stay(day)
Measured: From enrollment to postoperative 5 th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CIGDEM YILDIRIM GUCLU, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353788
- Sponsor's protocol ID
- 15.10.2025
- Acronym
- POWEROL
- Status last verified
- Oct 2025
- First submitted
- 9 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Complications and Outcomes Related to Mechanical Power in One-lung Ventilation- A Multicentre Observational Study
- ClinicalTrials.gov ID
- NCT07353788
- Acronym / sponsor ID
- POWEROL / 15.10.2025
- Conditions
- Thoracic Anesthesia, Thoracotomy Surgery
- Keywords
- one lung ventilation, mechanical power, postoperative pulmonary complications
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospital
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 1-Patients undergoing cardiac surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.]
5 secondary outcomes
Threshold mechanical power (J/min)associated with PPCs
Time frame: From enrollment to postoperative 5 th day
Unscheduled ICU admission rates
Time frame: From enrollment to postoperative 5 th day
Extra-pulmonary postoperative complications(number of complications)
Time frame: From enrollment to postoperative 5 th day
Length of ICU stay(day)
Time frame: up to 5 th day
Length of hospital stay(day)
Time frame: From enrollment to postoperative 5 th day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Anesthesia and Thoracotomy Surgery, run by Ankara University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CIGDEM YILDIRIM GUCLU, Prof Dr (+905324576648, drcigdemyldrm@yahoo.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.