Stroke Volume Variations and Pulse Pressure Variations Undergoing Artificial Pneumothorax Surgery

December 8, 2022 updated by: Yu Chen, MD, Chinese PLA General Hospital

Accuracy of Stroke Volume Variation and Pulse Pressure Variation to Predict Fluid Responsiveness in Patients With Artificial Pneumothorax During Esophageal Surgery

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100048
        • The Sixth Medical Center of Chinese PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Mi Weidong, Doctor, Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

September 20, 2022

Study Completion (Actual)

November 15, 2022

Study Registration Dates

First Submitted

November 19, 2022

First Submitted That Met QC Criteria

December 8, 2022

First Posted (Estimate)

December 9, 2022

Study Record Updates

Last Update Posted (Estimate)

December 9, 2022

Last Update Submitted That Met QC Criteria

December 8, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • CY2022-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We don't want to share plan

Drug and device information, study documents

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

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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