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

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ClinicalTrials.gov Identifier: NCT02220231
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : April 17, 2015
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Mediastinal Tumors Procedure: capnothorax Not Applicable

Detailed Description:
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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Echocardiographic Evaluation of the Change on Pulmonary Blood Flow and Cardiac Function Induced by Capnothorax During One Lung Ventilation
Study Start Date : August 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Arm Intervention/treatment
Experimental: capnothorax group
After patient positioning, the capnothorax will be created by insufflation of carbon dioxide in patients undergoing video-assisted thoracoscopic extended thymectomy.
Procedure: capnothorax
After patient positioning, the capnothorax will be created by insufflation of carbon dioxide in patients undergoing video-assisted thoracoscopic extended thymectomy.
Other Name: VATET, capnothorax, TEE




Primary Outcome Measures :
  1. The changes of the echocardiographic indices [ Time Frame: 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 ]
    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


Secondary Outcome Measures :
  1. The changes of the oxygenation and respiratory dynamic parameters [ Time Frame: 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 ]
    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



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02220231     History of Changes
Other Study ID Numbers: 4-2014-0492
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015

Keywords provided by Yonsei University:
mediastinal mass, one-lung ventilation, capnothorax, transesophageal echocardiography

Additional relevant MeSH terms:
Mediastinal Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Mediastinal Diseases
Thoracic Diseases
Respiratory Tract Diseases