Video-assisted Thoracic Surgery Clinical Trial
Verified date | April 2015 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Korea: Institutional Review Board |
Study type | Interventional |
The investigators used transesophageal echocardiography (TEE) to assess the change of pulmonary blood flow and bi-ventricular function during lung isolation. The investigators hypothesized that changes in pulmonary venous flow with lung isolation may be related the shunt fraction and oxygenation during one lung ventilation (OLV). The investigators also observed the cardiac function during two lung ventilation (TLV) and OLV in supine and lateral position by TEE.
Status | Completed |
Enrollment | 25 |
Est. completion date | March 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Above 20 years of age. - American Society of Anesthesiologists (ASA) Physical Status I and II - Thoracic surgical procedure (video-assisted) Exclusion Criteria: - severe functional liver or kidney disease - cardiac disease - arrhythmia - exceed BMI > 30 kg/ m2 - COPD - pathologic esophageal lesion (esophageal stricture or varix ) - pregnancy |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change of pulmonary blood flow | 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 | two-lung ventilation in the supine (T1) and lateral position (T2) and 10 (T3), 20 (T4), and 30 min (T5) during OLV in the left lateral decubitus position. | Yes |
Secondary | The changes of respiratory 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 | two-lung ventilation in the supine (T1) and lateral position (T2) and 10 (T3), 20 (T4), and 30 min (T5) during OLV in the left lateral decubitus position. | Yes |
Secondary | The change of cardiac function | two-lung ventilation in the supine (T1) and lateral position (T2) and 10 (T3), 20 (T4), and 30 min (T5) during OLV in the left lateral decubitus position. | Yes |
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