Clinical trial NCT02123173: Hemodynamic Changes During One Lung Ventilation in Non-intubated Vedio-assisted Thoracoscopic Operations
Official title: Hemodynamic Changes and Fluid Responsiveness During One Lung Ventilation: Comparison in Non-intubated and Intubated Vedio-assisted Thoracoscopic Operations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Neoplasms
Keywords: one lung ventilation,
cardiac output
fluid responsiveness
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-04-25
Enrollment: 71
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: cardiac output after one lung ventilation
timeFrame: 10-15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: department of anesthesiology, national taiwan university hospital
name: Ya-Jung Cheng
role: PRINCIPAL_INVESTIGATOR
References: