Echocardiographic Evaluation of the Change on Pulmonary Blood Flow and Cardiac Function Induced by Capnothorax During One Lung Ventilation

NCT02220231 | Completed

• 1 other identifier: 4-2014-0492
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Mediastinal Tumors

Keywords

mediastinal mass, one-lung ventilation, capnothorax, transesophageal echocardiography

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The changes of the oxygenation and respiratory dynamic parameters

  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

Study Arms (1)

capnothorax group

EXPERIMENTAL

After patient positioning, the capnothorax will be created by insufflation of carbon dioxide in patients undergoing video-assisted thoracoscopic extended thymectomy.

Procedure: capnothorax

Interventions

capnothorax PROCEDURE

After patient positioning, the capnothorax will be created by insufflation of carbon dioxide in patients undergoing video-assisted thoracoscopic extended thymectomy.

Also known as: VATET, capnothorax, TEE

capnothorax group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above 20 years of age.
• American Society of Anesthesiologists (ASA) Physical Status I, II, III.
• Thoracic surgical procedure (video-assisted thoracoscopic extended thymectomy )

You may not qualify if:

• Severe functional liver or kidney disease
• Diagnosed HF ( NYHA class \>3)
• Arrhythmia or received treatment with antiarrhythmic drug .
• Exceed BMI \> 30 kg/ m2
• COPD
• Pathologic esophageal lesion (esophageal stricture or varix )
• Pregnancy

Sponsors & Collaborators

• Yonsei University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 19, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 17, 2015

Record last verified: 2015-04