Clinical trial NCT05644405: 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
Overall status: COMPLETED
Phase: NA
Conditions: Artificial; Complications, Heart
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: The area under the receiver operating characteristic (ROC) curve
timeFrame: 1YEARS
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Sixth Medical Center of Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Mi Weidong, Doctor
role: STUDY_CHAIR
References:
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.
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.