NCT02365311

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 17, 2015

Status Verified

April 1, 2015

Enrollment Period

4 months

First QC Date

February 2, 2015

Last Update Submit

April 15, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (2)

  • The changes of respiratory parameters

    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.

  • 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.

Study Arms (1)

one lung group

EXPERIMENTAL
Procedure: transesophageal echocardiography(TEE)

Interventions

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.

one lung group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Above 20 years of age.
  • American Society of Anesthesiologists (ASA) Physical Status I and II
  • Thoracic surgical procedure (video-assisted)

You may not qualify if:

  • severe functional liver or kidney disease
  • cardiac disease
  • arrhythmia
  • exceed BMI \> 30 kg/ m2
  • COPD
  • pathologic esophageal lesion (esophageal stricture or varix )
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

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

February 2, 2015

First Posted

February 18, 2015

Study Start

September 1, 2014

Primary Completion

January 1, 2015

Study Completion

March 1, 2015

Last Updated

April 17, 2015

Record last verified: 2015-04

Locations