Back to resultsPassive Leg Raise Induced Stroke Volume Changes in Elderly Prior to Elective Surgery Measured by LiDCOplusTM
Primary Purpose
Stroke Volume, Cardiovascular System, Fluid Therapy
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Passive leg raise
Sponsored by
About this trial
This is an interventional diagnostic trial for Stroke Volume
Eligibility Criteria
Inclusion Criteria:
- patients ≥80 years of age, undergoing elective urologic surgical procedure
Exclusion Criteria:
- age <80 years, severe aortic insufficiency, first case of the day on the operation program, unavailability of research personnel and contraindication to Lithium.
Sites / Locations
- Karolinska University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Passive Leg Raise (PLR)
Arm Description
The patient is placed in a 45 degree recumbent position. Stroke volume is measured in ml. Intervention:The patient is placed horizontal and the legs are passively raised to 45 degrees. Measurement:The effect of the PLR on Stroke Volume is measured. Thereafter the patient is repositioned to the initial position and Stroke Volume is measured again.
Outcomes
Primary Outcome Measures
Assess passive leg raise responsiveness in spontaneously breathing aged patients.
Stroke volume changes in ml and as per cent change compared to baseline
Secondary Outcome Measures
Investigate whether there is an association between a positive response to passive leg raise on stroke volume and post spinal anesthesia.
Post spinal bloodpressure per cent change or 30 mmHg decrease
Full Information
NCT ID
NCT02977390
First Posted
November 22, 2016
Last Updated
November 30, 2016
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT02977390
Brief Title
Passive Leg Raise Induced Stroke Volume Changes in Elderly Prior to Elective Surgery Measured by LiDCOplusTM
Official Title
Passive Leg Raise Induced Stroke Volume Changes in Elderly Prior to Elective Surgery Measured by LiDCOplusTM to Guide Fluid Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a pilot study to investigate whether patients at advanced age are fluid responders via a reversible fluid challenge, the passive leg raise test. This will be measured with a non-invasive cardiac output monitor, the LiDCO (LiDCO Hemodynamic monitoring) .
Detailed Description
The intervention is as simple as a passive leg raise with measurement of effect on Stroke volume.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Volume, Cardiovascular System, 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
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Passive Leg Raise (PLR)
Arm Type
Other
Arm Description
The patient is placed in a 45 degree recumbent position. Stroke volume is measured in ml.
Intervention:The patient is placed horizontal and the legs are passively raised to 45 degrees.
Measurement:The effect of the PLR on Stroke Volume is measured. Thereafter the patient is repositioned to the initial position and Stroke Volume is measured again.
Intervention Type
Other
Intervention Name(s)
Passive leg raise
Intervention Description
By tilting the patient's bed from sitting 45 degrees to supine with legs tilted up 45 degrees we recruit the blood volume in the legs and can measure a reversible fluid challenge on stroke volume.
Primary Outcome Measure Information:
Title
Assess passive leg raise responsiveness in spontaneously breathing aged patients.
Description
Stroke volume changes in ml and as per cent change compared to baseline
Time Frame
Within 1 minute of the intervention
Secondary Outcome Measure Information:
Title
Investigate whether there is an association between a positive response to passive leg raise on stroke volume and post spinal anesthesia.
Description
Post spinal bloodpressure per cent change or 30 mmHg decrease
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients ≥80 years of age, undergoing elective urologic surgical procedure
Exclusion Criteria:
age <80 years, severe aortic insufficiency, first case of the day on the operation program, unavailability of research personnel and contraindication to Lithium.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigridur Kalman, Professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Huddinge
ZIP/Postal Code
14186
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Passive Leg Raise Induced Stroke Volume Changes in Elderly Prior to Elective Surgery Measured by LiDCOplusTM
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