Echocardiographic Evaluation of the Change on Pulmonary Blood Flow and Cardiac Function During One-lung Ventilation

Video-assisted Thoracic Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02365311
• Other study ID #: 4-2014-0486
• Status: Completed
• Phase: N/A
• First received: February 2, 2015
• Last updated: April 15, 2015
• Start date: September 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Video-assisted Thoracic Surgery

Intervention

Procedure:
• transesophageal echocardiography(TEE)
Transesophageal echocardiography examination will be performed TLV in supine and lateral position, 10, 20 and 30 min during OLV in left lateral decubitus position. By using the transesophageal echocardiography, we will evaluate the changes of pulmonary blood flow and cardiac function.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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