NCT07100860

Brief Summary

This observational study investigates the relationship between the duration of single-lung ventilation (SLV) and the incidence of postoperative pulmonary complications (PPCs) such as pneumonia, pneumothorax, hemothorax, acute lung injury, and acute respiratory distress syndrome (ARDS) in adult patients undergoing thoracic surgery. A total of 134 patients aged 18-85 years, scheduled for thoracic surgery requiring SLV, will be monitored. Data including SLV duration, perioperative parameters, and postoperative pulmonary outcomes will be analyzed.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 3, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

July 28, 2025

Last Update Submit

December 10, 2025

Conditions

Keywords

postoperative pulmonary complicationsone lung ventilation

Outcome Measures

Primary Outcomes (1)

  • Postopertive Pulmonary Complications

    Postoperative pulmonary complications (PPCs) are defined as respiratory events occurring within the first seven days following thoracic surgery, which negatively impact patient outcomes. In this study, PPCs include pneumonia, pneumothorax, hemothorax, acute lung injury, acute respiratory distress syndrome (ARDS), prolonged oxygen requirement, unplanned reintubation, and the need for non-invasive ventilation. These complications will be identified through clinical assessment, arterial blood gas analysis, and postoperative imaging such as chest X-rays. Each case will be evaluated using predefined diagnostic criteria to ensure consistency. The incidence of PPCs will be analyzed in relation to the duration of intraoperative single-lung ventilation.

    postoperative 7 days

Interventions

In this observational study, the naturally occurring duration of intraoperative single-lung ventilation (SLV) during thoracic surgery will be recorded. No intervention is applied or modified for research purposes. The exposure of interest is the total duration (in minutes) of SLV, which will be timed from initiation to termination during surgery. This variable will be analyzed in relation to postoperative pulmonary complications.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of adult patients aged 18 to 85 years who are scheduled to undergo thoracic surgery at Etlik City Hospital and require OLV during the procedure. Patients will be included if they meet the eligibility criteria of being over 18 years old, undergoing thoracic surgery, receiving intraoperative OLV, and providing informed consent to participate in the study. Patients will be excluded if they are part of the pediatric age group, do not require OLV, or decline participation. A total of 134 eligible patients will be prospectively enrolled and followed for seven days postoperatively to assess the occurrence of pulmonary complications.

You may qualify if:

  • Age ≥18 years Undergoing thoracic surgery OLV planned during the procedure

You may not qualify if:

  • Pediatric patients Patients not requiring OLV Previous thoracic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hazal Ekin GÜRAN AYTUĞ

Ankara, Ankara, 06810, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.

    PMID: 28186222BACKGROUND
  • Kiss T, Bluth T, Gama de Abreu M. [Does intraoperative lung-protective ventilation reduce postoperative pulmonary complications?]. Anaesthesist. 2016 Aug;65(8):573-9. doi: 10.1007/s00101-016-0198-8. German.

    PMID: 27392439BACKGROUND

MeSH Terms

Conditions

Acute Lung InjuryPulmonary Atelectasis

Interventions

One-Lung Ventilation

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeutics

Study Officials

  • Hazal EG AYTUĞ

    Consultant Anesthesiologist

    STUDY DIRECTOR

Central Study Contacts

Hazal EG AYTUĞ

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anesthesiologist

Study Record Dates

First Submitted

July 28, 2025

First Posted

August 3, 2025

Study Start

January 1, 2025

Primary Completion

December 1, 2025

Study Completion

January 1, 2026

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations