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

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT02220231
Collaborator
(none)
25
Enrollment
1
Arm
7
Duration (Months)

Study Details

Study Description

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
  • Procedure: capnothorax
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
N/A
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 :
Aug 1, 2014
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

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 Names:
  • VATET, capnothorax, TEE

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The changes of the echocardiographic indices [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT02220231
    Other Study ID Numbers:
    • 4-2014-0492
    First Posted:
    Aug 19, 2014
    Last Update Posted:
    Apr 17, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Yonsei University
    mediastinal mass, one-lung ventilation, capnothorax, transesophageal echocardiography
    Additional relevant MeSH terms:
    Mediastinal Neoplasms

    Study Results

    No Results Posted as of Apr 17, 2015