RSUD Prof. Margono Soekarjo
Purwokerto, Central Java, 53122, Indonesia
NCT Number: NCT07302243
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.
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Notify Me18 year–60 year
All sexes
Observational
Purwokerto, Central Java, 53122, Indonesia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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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.
Universitas Jenderal Soedirman
Other
Association Between One Lung Ventilation and Myocardial Injury Markers (Troponin T and I) in Thoracic Surgical Procedures : An Observational Cohort Study (OLVTIS)
Acronym: OLVTIS
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