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Thoracic AnesthesiaOLVTISNCT07302243

Association Between One Lung Ventilation and Myocardial Injury Markers (Troponin T and I) in Thoracic Surgical Procedures (OLVTIS)

An observational study of Thoracic Anesthesia and One Lung Ventillation (OLV), run by Universitas Jenderal Soedirman at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
How many people
39 participants
Where
1 siteIndonesia
Study dates
1 Jul 2025to 30 Sep 2025
Phase
Observational
Are there results?
None posted in the registry

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 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

  • 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)

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Indonesia1 site
  • RSUD Prof. Margono Soekarjo

    Purwokerto, Central Java, 53122

Other trials in Indonesia

About this study

Official title: Association Between One Lung Ventilation and Myocardial Injury Markers (Troponin T and I) in Thoracic Surgical Procedures : An Observational Cohort Study (OLVTIS)

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.

Read the detailed description

The one-lung ventilation (OLV) technique offers significant operative advantages but may cause various physiological complications that can potentially affect cardiovascular function. Intraoperative hemodynamic changes may lead to postoperative myocardial infarction and increase mortality risk. Aim To determine the differences in postoperative troponin T and I levels in thoracic surgery with OLV. This cohort study involved thirty nine patients who underwent thoracic surgery with OLV. All subjects received OLV with a ventilation ratio of 50% air to 50% oxygen, a tidal volume of 5-6 mL/kg body weight, and a respiratory rate of 12 breaths per minute. Troponin T and I levels were measured before and after surgery. Hemodynamic status and perioperative parameters were recorded.

Here is a clear, structured English version suitable for the Study Description → Detailed Description section of ClinicalTrials.gov:

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Detailed Study Procedures

Eligible participants who meet the study criteria will be identified by the research team. Each participant will receive a detailed explanation of the study objectives and procedures. Those who agree to participate will be asked to sign an informed consent form during the preoperative visit. all participants will undergo standard monitoring placement, including vital sign monitors and arterial line insertion. Patients will then be prepared for anesthesia induction.

Before the thoracic surgical procedure, baseline measurements will be obtained, including arterial blood gas (ABG) analysis and serum Troponin T and I levels.

All participants will receive general anesthesia. Induction will be performed using sufentanil (10-15 mcg), propofol (1.5-2.5 mg/kg), and rocuronium (0.6-1.2 mg/kg). Anesthesia maintenance will include sevoflurane (1-2%) and sufentanil infusion (5-20 mcg/hour). The anesthesia will be administered by anesthesia residents (5th semester or above) under supervision of an attending anesthesiologist.

Following successful endotracheal intubation using a double-lumen tube, mechanical ventilation will begin with a 50% oxygen and 50% air mixture. During two-lung ventilation, tidal volume will be set to 8 mL/kg with a respiratory rate of 12 breaths per minute. During one-lung ventilation (OLV), tidal volume will be adjusted to 5-6 mL/kg while maintaining a respiratory rate of 12 breaths per minute.

Throughout the surgical procedure, participants will undergo continuous hemodynamic monitoring. Additional intraoperative data, including duration of OLV and estimated blood loss, will be recorded. After surgery, patients will be transferred to the Intensive Care Unit (ICU) for postoperative monitoring.

All research participants will receive postoperative analgesia using a continuous sufentanil infusion at 0.1 mcg/kg/hour via syringe pump. Six hours after completion of the thoracic surgical procedure, postoperative ABG analysis and serum Troponin T and I levels will be obtained in the ICU. All collected research data will be documented, tabulated, and subsequently analyzed according to the study protocol.

Keywords
one lung ventilation, thoracic surgery, troponin, myocardial infarction
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07302243
Study groupRoleWhat they receive
Thoracotomy OLVA 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Pre operative baseline and 6 - 12 hours post operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2025
  2. Study start1 Jul 2025
  3. Primary completion30 Sep 2025
  4. Study completion30 Sep 2025

Resources

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
Cohort
Time perspective
Prospective
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07302243
Sponsor's protocol ID
UNSOED - OLV
Other IDs
108/KEPK/PE/2025
Acronym
OLVTIS
Status last verified
Dec 2025
First submitted
11 Dec 2025
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Thoracic Anesthesia and One Lung Ventillation (OLV), run by Universitas Jenderal Soedirman at 1 site in Indonesia.

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 3 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: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Troponin T Levels Pre- and Post-Thoracotomy with One-Lung Ventilation (time frame: Pre operative baseline and 6 - 12 hours post operative). 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 24 Dec 2025.

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