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.
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
- Conditions the study is for
- Thoracic Anesthesia, One Lung Ventillation (OLV)
- 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.
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:
-
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.
- Conditions
- Thoracic Anesthesia, One Lung Ventillation (OLV)
- 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 group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted24 Dec 2025
- Study start1 Jul 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Jenderal Soedirman
- Sponsor type
- University, hospital or other
- Collaborators
- RS Prof. Dr. Margono Soekardjo Purwokerto
- Responsible party
- Principal investigator, MM Rudi Prihatno, Universitas Jenderal Soedirman
- Investigators
- Rania Adeastri Hapsari, M.D, Principal investigator, Department of Anesthesiology and Intensive Care, Faculty of Medicine Jenderal Soedirman University / RSUD Prof. Dr. Margono Soekarjo Purwokerto. Purwokerto, Indonesia
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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between One Lung Ventilation and Myocardial Injury Markers (Troponin T and I) in Thoracic Surgical Procedures : An Observational Cohort Study (OLVTIS)
- ClinicalTrials.gov ID
- NCT07302243
- Acronym / sponsor ID
- OLVTIS / UNSOED - OLV
- Conditions
- Thoracic Anesthesia, One Lung Ventillation (OLV)
- Keywords
- one lung ventilation, thoracic surgery, troponin, myocardial infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Universitas Jenderal SoedirmanUniversity, hospital or other
- Collaborators
- RS Prof. Dr. Margono Soekardjo Purwokerto
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 24 Dec 2025 (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.
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.
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:
-
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- -
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
Change in Troponin T Levels Pre- and Post-Thoracotomy with One-Lung Ventilation
Time frame: Pre operative baseline and 6 - 12 hours post operative
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: 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.
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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. This study is not recruiting at the moment.
Rania Adeastri Hapsari, M.D principal investigator
Department of Anesthesiology and Intensive Care, Faculty of Medicine Jenderal Soedirman University / RSUD Prof. Dr. Margono Soekarjo Purwokerto. Purwokerto, Indonesia
1 site in 1 country: see every site and its status.
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.