NCT07353788

Brief 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. 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Feb 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

December 9, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 20, 2026

Status Verified

October 1, 2025

Enrollment Period

10 months

First QC Date

December 9, 2025

Last Update Submit

January 19, 2026

Conditions

Keywords

one lung ventilationmechanical powerpostoperative pulmonary complications

Outcome Measures

Primary Outcomes (1)

  • 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 \[Abbott et al. 2018 Br J Anaesth 2018 May;120(5):1066-1079.\]

    From enrollment to the end of postoperative 5 th day

Secondary Outcomes (5)

  • Threshold mechanical power (J/min)associated with PPCs

    From enrollment to postoperative 5 th day

  • Unscheduled ICU admission rates

    From enrollment to postoperative 5 th day

  • Extra-pulmonary postoperative complications(number of complications)

    From enrollment to postoperative 5 th day

  • Length of ICU stay(day)

    up to 5 th day

  • Length of hospital stay(day)

    From enrollment to postoperative 5 th day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hospital

You may qualify if:

  • 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

You may not qualify if:

  • Patients undergoing cardiac surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

CIGDEM YILDIRIM GUCLU, Prof Dr

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

December 9, 2025

First Posted

January 20, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 20, 2026

Record last verified: 2025-10