NCT07302243

Brief Summary

This prospective single-group cohort study aims to investigate the association between the One-Lung Ventilation (OLV) technique and myocardial injury, as measured by postoperative Troponin T and Troponin I levels, in patients undergoing thoracic surgery. All eligible participants will undergo standardized anesthesia and OLV techniques, with cardiac biomarkers collected before surgery and six hours postoperatively. The findings of this study are expected to provide a better understanding of the impact of OLV on myocardial stress or injury during thoracic surgical procedures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

December 11, 2025

Last Update Submit

December 11, 2025

Conditions

Keywords

one lung ventilationthoracic surgerytroponinmyocardial infarction

Outcome Measures

Primary Outcomes (1)

  • Change in Troponin T Levels Pre- and Post-Thoracotomy with One-Lung Ventilation

    Troponin T levels are measured before surgery and again 6-12 hours after the thoracotomy procedure to evaluate myocardial injury potentially associated with one-lung ventilation.

    Pre operative baseline and 6 - 12 hours post operative

Study Arms (1)

Thoracotomy OLV

A single cohort of adult patients undergoing thoracotomy with one-lung ventilation. All participants receive standard general anesthesia. No interventions are assigned. Preoperative and postoperative cardiac biomarkers (Troponin T and I) and arterial blood gases are collected to evaluate myocardial injury associated with OLV.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

* Patients who refuse to participate in the study * Patients undergoing thoracotomy surgery involving manipulation of the cardiovascular system * Patients with a history of heart disease and/or current cardiac treatment * Patients with severe hepatic or renal impairment * Patients with contraindications or allergies to the medications used in the study * Pregnant or Lactating women

You may qualify if:

  • Patients aged 18-60 years who requiring surgical thoracotomy with one lung ventilation
  • Classified as ASA Physical Status I - III
  • Provide Informed concent ( patient or legal representative)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RSUD Prof. Margono Soekarjo

Purwokerto, Central Java, 53122, Indonesia

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Rania Adeastri Hapsari, M.D

    Department of Anesthesiology and Intensive Care, Faculty of Medicine Jenderal Soedirman University / RSUD Prof. Dr. Margono Soekarjo Purwokerto. Purwokerto, Indonesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Neuroanesthesiologist and Dean, Faculty of Medicine, Jenderal Soedirman University

Study Record Dates

First Submitted

December 11, 2025

First Posted

December 24, 2025

Study Start

July 1, 2025

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

The individual participant data (IPD) will not be shared because of institutional privacy policy and ethical considerations involving patient data from RSUD Prof. Dr. Margono Soekarjo Purwokerto.

Locations