- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05644405
Stroke Volume Variations and Pulse Pressure Variations Undergoing Artificial Pneumothorax Surgery
Accuracy of Stroke Volume Variation and Pulse Pressure Variation to Predict Fluid Responsiveness in Patients With Artificial Pneumothorax During Esophageal Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100048
- The Sixth Medical Center of Chinese PLA General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The area under the receiver operating characteristic (ROC) curve
Time Frame: 1YEARS
|
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.
|
1YEARS
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mi Weidong, Doctor, Chinese PLA General Hospital
Publications and helpful links
General Publications
- 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). pii: 2335. doi: 10.3390/jcm10112335.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CY2022-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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