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

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02123173
• Other study ID #: 201401037RINB
• Status: Completed
• Phase: N/A
• First received: April 21, 2014
• Last updated: December 3, 2014
• Start date: May 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Neoplasms

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No