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OpenTrials
Completed

NCT Number: NCT02123173

Hemodynamic Changes During One Lung Ventilation in Non-intubated Vedio-assisted Thoracoscopic Operations

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, Taiwan, 100

About this study

Non-intubated vedio-assisted thoracoscopic (VATS) is proved safely performed as well as traditional intubated VATS. However, the differences of hemodynamic changes and fluid responsiveness during one lung ventilation(OLV) between these two groups were rarely reported. For complete lung collapse, spontaneous negative pressure respiration must be well maintained on non-intubated VATS. In comparison, positive pressure ventilation on dependent lung was applied during OLV in intubated VATS. This study planned to compared the changes of hemodynamics (including blood pressure, heart rate, cardiac output) during OLV between groups. As functional hemodynamic monitoring (FloTrac system) was mostly utilized with positive pressure ventilation, the applicability of FloTrac in non- intubated VATS was also testified. In this study, we also measure the fluid responsiveness by FloTrac system with rapid infusion (within 10 minutes) of 10 mL/kg crystalloid fluid. We planned to compare the changes on cardiac output and the fluid responsiveness during OLV between these two groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion:

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

Treatment and study plan

Primary outcomes

  1. cardiac output after one lung ventilation

    Time frame: 10-15 minutes

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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Hemodynamic Changes and Fluid Responsiveness During One Lung Ventilation: Comparison in Non-intubated and Intubated Vedio-assisted Thoracoscopic Operations

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 25, 2014
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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