Back to resultsSVV and PPV Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia
Primary Purpose
Stroke Volume Variation, Pulse Pressure Variation, Fluid Responsiveness
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
volume expansion
Sponsored by
About this trial
This is an interventional diagnostic trial for Stroke Volume Variation
Eligibility Criteria
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.
Sites / Locations
- Chinese PLA General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
observed patients
Arm Description
Outcomes
Primary Outcome Measures
Fluid responsiveness
Fluid responsiveness was defined as an increase in CI ≥15%
Secondary Outcome Measures
Full Information
NCT ID
NCT04388995
First Posted
May 11, 2020
Last Updated
August 25, 2020
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04388995
Brief Title
SVV and PPV Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia
Official Title
Stroke Volume Variation and Pulse Pressure Variation Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 12, 2020 (Actual)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
August 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Volume Variation, Pulse Pressure Variation, Fluid Responsiveness, Fluid Therapy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
observed patients
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
volume expansion
Intervention Description
volume expansion with 6% hydroxyethyl starch (7 mL/kg) at a rate of 0.4 mL/kg/min
Primary Outcome Measure Information:
Title
Fluid responsiveness
Description
Fluid responsiveness was defined as an increase in CI ≥15%
Time Frame
immediately after the fluid therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Haidian
ZIP/Postal Code
100853
Country
China
12. IPD Sharing Statement
Learn more about this trial
SVV and PPV Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia
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