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NCT04388995 Clinical Trial

SVV and PPV Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia

Fluid Responsiveness Clinical Trial

Official title:
Stroke Volume Variation and Pulse Pressure Variation Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04388995
Other study ID # PLAGHAOC202002
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date May 12, 2020
Est. completion date August 31, 2020

Study information
Verified date August 2020
Source Chinese PLA General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Although individualized or goal-directed approach has been advocated, a reliable index is still required to help monitor the volume status timely and efficiently. Dynamic indexes, such as pulse pressure variation (PPV) and stroke volume variation (SVV), have been shown to be clearly superior to more commonly measured static preload variables, such as pulmonary artery occlusion pressure (PAOP) and central venous pressure (CVP). The reliability of dynamic indexes in monitoring the volume status and predicting fluid responsiveness have been validated. Fluid optimization guided by SVV and PPV is beneficial to hemodynamic stability and can decrease mortality and reduce postoperative complications. However, the usefulness of dynamic indexes in elderly patients has not been previously investigated. This study aimed to evaluate whether dynamic indexes PPV and SVV can reliably predict fluid responsiveness in elderly patients, and to determine their thresholds in elderly patients.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 60
Est. completion date August 31, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers No
Gender All
Age group 16 Years to 80 Years
Eligibility Inclusion Criteria:

- 1.Patients undergoing gastrointestinal surgery 2.Age between 18 and 80 3.ASA I ~II. 4.BMI 18 ~ 24 kg/m2

Exclusion Criteria:

- 1.arrhythmias 2.intracardiac shunts 3.severe hypertension (SBP = 160 mmHg or DBP = 100 mmHg) 4.pulmonary hypertension 5.chronic obstructive pulmonary disease 6.peripheral vascular obstructive disease 7.receiving long-term treatment with vasopressors.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• volume expansion
volume expansion with 6% hydroxyethyl starch (7 mL/kg) at a rate of 0.4 mL/kg/min

Locations
Country Name City State
China Chinese PLA General Hospital Beijing Haidian

Sponsors (1)
Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fluid responsiveness Fluid responsiveness was defined as an increase in CI =15% immediately after the fluid therapy
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