Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04030221
Other study ID # 2019-153
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 20, 2019
Est. completion date August 20, 2019

Study information

Verified date July 2019
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Yan Min, Doctor
Phone +86-13757118632
Email zryanmin@ziu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Surgical patients, especially those with insufficient blood volume and hypotension, often need fluid therapy. However, there is still a lack of simple and reliable indicators for judging transfusion responsiveness in some types of surgery. Previous studies have shown that Pressure Gradient for Venous Return (PVR) can be used to guide infusion. Thus, our aim is to explore the relationship between PVR and liquid reactivity.


Description:

Fluid resuscitation is one of the key issues in the management of surgery and anesthesia. Fluid infusion test is a method to determine patients' reactivity to liquid therapy. The commonly used Stroke Volume Variation (SVV) and Pulse Pressure Variation (PPV) are good predictors of fluid responsiveness, but they are not suitable for operations with increased intra-abdominal pressure, such as laparoscopy surgery. Some studies have shown that Pressure Gradient for Venous Return (PVR) may has the same effect as PPV/SVV in predicting fluid responsiveness (FR). In the case that PPV/SVV cannot be used, PVR may be used alternatively. Therefore, our aim is to explore the relationship between the changes of PVR and fluid responsiveness during liquid infusion and to determine relevant parameters.

We will choose patients planed to receive laparoscopic surgery and general anesthesia, especially the patients with gastrointestinal tumors because of generally long operation time and much infusion volume. In our hospital, these patients will routinely indwelled arterial catheters and deep venous catheters during the operation. The former is mainly used to monitor direct arterial pressure, and the latter is used for fluid infusion.Through the above two pathways, we can collect the hemodynamic parameters of patients, and then establish the relationship between PVR and FR.

In our study, a good FR was defined as a 10% increase in cardiac index (CI) after fluid infusion, and PVR is calculated by a special formula based on some specific parameters of hemodynamics.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date August 20, 2019
Est. primary completion date August 20, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients undergoing laparoscopic surgery and general anesthesia

Exclusion Criteria:

- cardiac insufficiency; severe arrhythmias; patients using intra-aortic balloon pump; use of left ventricular assist devices; spasm of peripheral arteries caused by some factor

Study Design


Related Conditions & MeSH terms


Intervention

Other:
fluid infusion
250 ml of liquid will be given within 10 minutes for each patients, and the hemodynamic parameters before and after fluid infusion will be recorded. Then the experiment is completed.

Locations

Country Name City State
China The second affiliated hospital of Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary hemodynamic parameters direct arterial pressure including systolic, diastolic and mean arterial pressure; central venous pressure.These data are collected continuously and dynamically. At enrollment
See also
  Status Clinical Trial Phase
Not yet recruiting NCT01941472 - Transcutaneous pO2, Transcutaneous pCO2 and Central Venous pO2 Variations to Predict Fluid Responsiveness N/A
Terminated NCT03208023 - RESIPI for Reducing Perioperative Major Adverse Cardiac Events N/A
Completed NCT03713008 - Assessment Of Carotid Flow During General Anesthesia N/A
Completed NCT02277353 - Evaluation of SVV From NICOM as a Predictor of Fluid Responsiveness in Prone Position During Spine Surgery N/A
Not yet recruiting NCT04092036 - Optic Nerve Sheath Diameter in Prediction of Fluid Responsiveness
Completed NCT04060069 - Pneumoperitoneum and Trendelenburg Position on Fluid Responsiveness
Recruiting NCT05153837 - Effect of Oral Water in Healthy Volunteers on Cardiac Output, Regional Flow and Microcirculation in Healthy Volunteers N/A
Not yet recruiting NCT06143111 - A Comparison of Thoracic Electrical Bioimpedance and FloTrac/Vigileo N/A
Not yet recruiting NCT05601622 - RPVI for Fluid Responsiveness in Children N/A
Completed NCT04889807 - Study of End Tidal Carbon Dioxide (EtCO2) Variation After an End- Expiratory Occlusion Test as a Predictive Criteria of Fluid Responsiveness in Mechanically Ventilated Patients
Recruiting NCT04186416 - Effectiveness of the Pressure Recording Analytical Method in Predicting Fluid Responsiveness in Pediatric Critical Care Patients
Completed NCT01996956 - Prediction of Fluid Responsiveness by NICOM (Non-invasive Cardiac Output Monitoring) in Children With Congenital Heart Disease After Cardiac Surgery N/A
Enrolling by invitation NCT04388995 - SVV and PPV Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia N/A
Not yet recruiting NCT04574011 - Fluid Responsiveness in Spontaneously Ventilating Patient N/A
Completed NCT01821742 - Echocardiography in Kids Intensive Care Decision Support
Completed NCT04802668 - Factors Influencing of Pulse Pressure Variation (PPV)
Not yet recruiting NCT06254456 - Fluid Responsiveness in Prone Patients N/A
Completed NCT02789124 - Diagnostic Value of Passive Leg Raise Induced Changes in Carotid Artery Flow Time to Predict Fluid Responsiveness in Critically Ill Patients N/A
Withdrawn NCT01898975 - A Gray Zone Approach to Stroke Volume Variation Derived From NICOM N/A
Completed NCT02040948 - Accuracy of Pulse Pressure Variation and of Pleth Variability Index to Predict the Response to a Fluid Challenge N/A