Mediastinal Tumors Clinical Trial
Official title:
Echocardiographic Evaluation of the Change on Pulmonary Blood Flow and Cardiac Function Induced by Capnothorax During One Lung Ventilation
| Verified date | April 2015 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | South Korea: Institutional Review Board |
| Study type | Interventional |
Video-assisted thoracoscopic extended thymectomy (VATET) is a minimally-invasive method for excision of mediastinal mass instead of open thymectomy. The iatrogenic capnothorax with one-lung ventilation during VATET may cause hemodynamic instability due to the compression of intrathoracic structures. The purpose of this study is to evaluate the effects of capnothorax on the pulmonary blood flow and cardiac function during the VATET by using the transesophageal echocardiography.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 80 Years |
| Eligibility |
Inclusion Criteria: 1. Above 20 years of age. 2. American Society of Anesthesiologists (ASA) Physical Status I, II, III. 3. Thoracic surgical procedure (video-assisted thoracoscopic extended thymectomy ) Exclusion Criteria: 1. Severe functional liver or kidney disease 2. Diagnosed HF ( NYHA class >3) 3. Arrhythmia or received treatment with antiarrhythmic drug . 4. Exceed BMI > 30 kg/ m2 5. COPD 6. Pathologic esophageal lesion (esophageal stricture or varix ) 7. Pregnancy |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The changes of the echocardiographic indices | pulmonary blood flow = PVA(cross sectional area of LUPV) x VTI(velocity time integral) x HR , Fractional area change = [(LVAd-LVAs)/LVAd] × 100 Ejection fraction = [(LVEDV(LV end-diastolic volume) -LVESV(LV end-systolic volume)/LVEDV] × 100 | four time points during the operation. (1)10 min after induction (baseline); (2) 1 min after CO2 insufflation; (3)10 min after of CO2 insufflation; and (4)20 min after CO2 insufflation | Yes |
| Secondary | The changes of the oxygenation and respiratory dynamic parameters | shunt fraction Qs/Qt = (CcO2- CaO2)/(CcO2- CvO2) CcO2 = Hgb x 1.34 x ScO2 + PcO2 x 0.003, lung compliance : Compliance= Vt / Pplat, physiologic dead space : Vd/Vt = 1.14 x (PaCO2 - PETCO2)/PaCO2- 0.005 | four time points during the operation, an expected average of 3 hours. (1)10 min after induction (baseline); (2) 1 min after CO2 insufflation; (3)10 min after of CO2 insufflation; and (4)20 min after CO2 insufflation | Yes |