Stroke Volume Variations and Pulse Pressure Variations Undergoing Artificial Pneumothorax Surgery
Primary Purpose
Artificial; Complications, Heart
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
FloTrac Vigileo
Sponsored by
About this trial
This is an interventional diagnostic trial for Artificial; Complications, Heart
Eligibility Criteria
Inclusion Criteria: Must be arranged for thoracoscopic surgical treatment of esophageal cancer Must be mechanically ventilated with artificial Pneumothorax during the operation Must be normal in Allen test. Exclusion Criteria: Hypertension Coronary heart disease Arrhythmia Left ventricle ejection fractions < 50% (EF<50%) Pulmonary hypertension Congenital cardiovascular malformation Peripheral vascular disease Long-term history of oral vasoactive drugs
Sites / Locations
- The Sixth Medical Center of Chinese PLA General Hospital
Outcomes
Primary Outcome Measures
The area under the receiver operating characteristic (ROC) curve
According to the area under the curve, the predictive ability and the diagnostic thresholds of SVV and PPV were determined. The p value less than 0.05 was regarded as statistically significant.
Secondary Outcome Measures
Full Information
NCT ID
NCT05644405
First Posted
November 19, 2022
Last Updated
December 8, 2022
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05644405
Brief Title
Stroke Volume Variations and Pulse Pressure Variations Undergoing Artificial Pneumothorax Surgery
Official Title
Accuracy of Stroke Volume Variation and Pulse Pressure Variation to Predict Fluid Responsiveness in Patients With Artificial Pneumothorax During Esophageal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
September 20, 2022 (Actual)
Study Completion Date
November 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Stroke volume variation (SVV) and pulse pressure variation (PPV) have been thought to be sensitive predictors of fluid responsiveness in mechanically ventilated participants. In this paper, the investigators reported a special group of people to use SVV and PPV during their operation. The maintenance of hemodynamic stability and the critical organ perfusion is crucial to the treatment for patients with artificial Pneumothorax during esophageal surgery, because artificial pneumothorax causes incomplete ventilation of one lung. In addition, artificial pneumothorax may seriously affect theparticipant's heart and lung function, brings more challenges to the intraoperative anesthetic management, expecially in volume management. Little information is available about the accuracy of SVV and PPV to predict fluid responsiveness in participants with artificial Pneumothorax during esophageal surgery. It is unclear whether it will affect the accuracy of SVV and PPV, and whether it will cause the change of their threshold values. The investigators will discuss it in the passage and the investigators will give an preliminary mechanism to explain the results.
Detailed Description
Backgroud: This study aims to evaluate the ability of stroke volume variation (SVV) and pulse pressure variation (PPV) to predict fluid responsiveness in mechanically ventilated participants with artificial Pneumothorax during esophageal surgery.
Methods: 40 participants, diagnosed with esophageal cancer, undergoing thoracoscopic radical resection of esophageal cancer were studied. All the participants used Vigileo/FloTrac system for analysis. Haemodynamic data such as MAP, HR, SV, SVI, CO, CI, SVV, PPV were recorded before and after volume expansion (VE). Fluid responsiveness was defined as an increase in SVI≥10%(△SVI≥10%). Participants were divided into Responders and Non-responders by changes in △SVI ≥10% and < 10%. Nonparametric Wilcoxon rank sum test was used to compare the hemodynamic parameters of Responders and Non-responders before and after VE. Pearson correlation analysis was used to analyze the values of SVV, PPV and △SVI. The receiver operating characteristic (ROC) curve of each hemodynamic index was drawn to determine its accuracy and threshold.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Artificial; Complications, Heart
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
FloTrac Vigileo
Intervention Description
A dedicated transducer (FloTrac TM, Edwards Lifesciences, LLC, Irvine, CA, USA) was connected to the radial arterial line on one side and to the Vigileo System (Vigileo TM Edwards Lifesciences, LLC, Irvine, CA, USA) on the other side
Primary Outcome Measure Information:
Title
The area under the receiver operating characteristic (ROC) curve
Description
According to the area under the curve, the predictive ability and the diagnostic thresholds of SVV and PPV were determined. The p value less than 0.05 was regarded as statistically significant.
Time Frame
1YEARS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Must be arranged for thoracoscopic surgical treatment of esophageal cancer Must be mechanically ventilated with artificial Pneumothorax during the operation Must be normal in Allen test.
Exclusion Criteria:
Hypertension Coronary heart disease Arrhythmia Left ventricle ejection fractions < 50% (EF<50%) Pulmonary hypertension Congenital cardiovascular malformation Peripheral vascular disease Long-term history of oral vasoactive drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mi Weidong, Doctor
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
The Sixth Medical Center of Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100048
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We don't want to share plan
Citations:
PubMed Identifier
34071746
Citation
Choi KH, Shim JK, Kim DW, Byun CS, Park JH. Dynamic Indices Fail to Predict Fluid Responsiveness in Patients Undergoing One-Lung Ventilation for Thoracoscopic Surgery. J Clin Med. 2021 May 27;10(11):2335. doi: 10.3390/jcm10112335.
Results Reference
result
PubMed Identifier
33882958
Citation
Chuang KH, Lai HH, Chen Y, Chen LC, Lu HI, Chen YH, Li SH, Lo CM. Improvement of surgical complications using single-lumen endotracheal tube intubation and artificial carbon dioxide pneumothorax in esophagectomy: a meta-analysis. J Cardiothorac Surg. 2021 Apr 21;16(1):100. doi: 10.1186/s13019-021-01459-1.
Results Reference
result
Learn more about this trial
Stroke Volume Variations and Pulse Pressure Variations Undergoing Artificial Pneumothorax Surgery
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