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

NCT ID: NCT07302243

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 39 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2025-09-30

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.

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.

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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.

Conditions

Thoracic Anesthesia; One Lung Ventillation (OLV)

Keywords

one lung ventilation; thoracic surgery; troponin; myocardial infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RS Prof. Dr. Margono Soekardjo Purwokerto

UNKNOWN

Sponsor Role: collaborator

Universitas Jenderal Soedirman

OTHER

Sponsor Role: lead

Responsible Party

MM Rudi Prihatno

Consultant Neuroanesthesiologist and Dean, Faculty of Medicine, Jenderal Soedirman University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rania Adeastri Hapsari, M.D

Role: PRINCIPAL_INVESTIGATOR

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

Locations

RSUD Prof. Margono Soekarjo

Purwokerto, Central Java, Indonesia

Countries

Indonesia

Other Identifiers

108/KEPK/PE/2025

Identifier Type: OTHER

Identifier Source: secondary_id

UNSOED - OLV

Identifier Type: -

Identifier Source: org_study_id