NCT02123173

Brief Summary

Non-intubated thoracoscopic surgery has been proved as an adequate alternative for management of many lung conditions such as pneumothorax , lung volume reduction, pulmonary metastasectomy, removal of lung nodules, segmentectomy and lobectomy. However, the hemodynamic changes during one lung ventilation have not been fully investigated. The goals of this study are to compare the changes of hemodynamics (including blood pressure, heart rate, cardiac output, pulse pressure variation, fluid responsiveness) during one lung ventilation between conventional intubated and non-intubated vedio-assisted thoracoscopic (VATS) operations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2014

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

April 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

6 months

First QC Date

April 21, 2014

Last Update Submit

December 3, 2014

Conditions

Keywords

one lung ventilation,cardiac outputfluid responsiveness

Outcome Measures

Primary Outcomes (1)

  • cardiac output after one lung ventilation

    record the stroke volume and cardiac output during two lung ventilation till 15 minutes after one lung ventilation

    10-15 minutes

Study Arms (2)

non-intubated

VATS, non-intubated

intubated

VATS, intubated

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients scheduled to receive video-assisted thoracoscopic (VATS) operations with one lung ventilation(OLV) Inclusion criteria: 1. age over 20 y/o, less than 70 y/o 2. scheduled to receive VATS operations with OLV Exclusion: 1. previous thoracic surgery 2. cardiac disease ( including arrhythmias, congestive heart failure, coronary cardiac disease, etc.) 3. pulmonary disease

You may qualify if:

  • age over 20 y/o, less than 70 y/o
  • scheduled to receive VATS operations with OLV

You may not qualify if:

  • previous thoracic surgery
  • cardiac disease ( including arrhythmias, congestive heart failure, coronary cardiac disease, etc.)
  • pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ya-Jung Cheng

    department of anesthesiology, national taiwan university hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2014

First Posted

April 25, 2014

Study Start

May 1, 2014

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations