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Passive Leg Raising Test to Predict Hypotension During Induction of Anesthesia in Patients Undergoing Cardiac Surgery

Primary Purpose

Ischemic Heart Disease, Cardiac Valve Disease

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
passive leg raising (45 degree leg elevation for 1-2 min)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemic Heart Disease focused on measuring Passive leg raising, FloTrac/Vigileo, Anesthesia hypotension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult patients undergoing elective cardiac surgery

Exclusion Criteria:

  • arrhythmias
  • documented peripheral artery disease
  • severe pulmonary disease
  • heart failure
  • unstable angina
  • preoperative use of inotropics or mechanical assist device
  • use of angiotensin converting enzyme inhibitors
  • expected intubation difficulty or gastric reflux disease

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Passive Leg Raising

Arm Description

elevation of both legs to a 45 degrees for about 1-2 minute before anesthesia induction

Outcomes

Primary Outcome Measures

The area under ROC curve to predict hypotension and refractory hypotension
area under ROC curve of HR, SV, SVV, and CI changes during PLR to predict hypotension and refractory hypotension

Secondary Outcome Measures

Full Information

First Posted
June 8, 2010
Last Updated
June 14, 2010
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01144546
Brief Title
Passive Leg Raising Test to Predict Hypotension During Induction of Anesthesia in Patients Undergoing Cardiac Surgery
Official Title
Passive Leg Raising Test to Predict Hypotension During Induction of Anesthesia in Patients Undergoing Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Hypotension frequently occurs during anesthesia induction. Preload decrease by anesthetics was often considered as one of main causes for this hypotension. However, the studies on this topic have been lacking. Dynamic preload indices are more suitable than static preload indices to predict the effect of preload changes. And, recently, passive leg raising test showed successful results to predict fluid responsiveness in patient with spontaneous ventilation. The investigators hypothesized that hypotension after induction of anesthesia is caused by decrease of preload by anesthetics and passive leg raising test could predict this hypotension. In this study, the investigators will try to evaluate whether passive leg raising induced hemodynamic changes could predict hypotension during anesthesia induction.
Detailed Description
In this randomized controlled clinical trial, the investigators hypothesized that passive leg raising induced changes in hemodynamic parameters could predict the hypotension during anesthesia induction. To evaluate this, before anesthesia, the investigators will conduct passive leg raising test. At first, the patient's trunk was elevated 45 degrees for the first set of measurements. Then, the lower limbs were raised to a 45° angle while the patient's trunk was lowered to a supine position to measure peak CO (usually within 1-2 min). Hemodynamic profiles planned to be measured are mean arterial pressure, heart rate, cardiac index, stoke volume and stroke volume variation. After this, the occurrence of hypotension (systolic blood pressure < 90mmHg or mean arterial pressure decrease > 30% of baseline) will be recorded during the time from anesthesia induction to surgical skin incision. Hypotension will be treated by a standardized method. If heart rate (HR) is less than 70 beats/min, 5mg of ephedrine will be administered and if HR is greater than 70 beats/min, 30 mcg of phenylephrine will be administered. This will repeated until hypotension subsided. Refractory hypotension will be defined as continuous hypotension despite the total infused dose of ephedrine > 0.5 mg/kg or phenylephrine > 4 mcg/kg. The ability to predict hypotension and refractory hypotension during anesthesia induction by passive leg raising test will be evaluated by receiver operating characteristic curve analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Cardiac Valve Disease
Keywords
Passive leg raising, FloTrac/Vigileo, Anesthesia hypotension

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Passive Leg Raising
Arm Type
Experimental
Arm Description
elevation of both legs to a 45 degrees for about 1-2 minute before anesthesia induction
Intervention Type
Procedure
Intervention Name(s)
passive leg raising (45 degree leg elevation for 1-2 min)
Other Intervention Name(s)
PLR
Intervention Description
the patient's trunk was elevated 45 degrees for the first set of measurements. Then, the lower limbs were raised to a 45° angle while the patient's trunk was lowered to a supine position to measure peak CO (usually within 1-2 min)
Primary Outcome Measure Information:
Title
The area under ROC curve to predict hypotension and refractory hypotension
Description
area under ROC curve of HR, SV, SVV, and CI changes during PLR to predict hypotension and refractory hypotension
Time Frame
30 min around passive leg raising test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients undergoing elective cardiac surgery Exclusion Criteria: arrhythmias documented peripheral artery disease severe pulmonary disease heart failure unstable angina preoperative use of inotropics or mechanical assist device use of angiotensin converting enzyme inhibitors expected intubation difficulty or gastric reflux disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunseok Jeon, M.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Passive Leg Raising Test to Predict Hypotension During Induction of Anesthesia in Patients Undergoing Cardiac Surgery

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