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Passive Leg Raising Attenuates and Delays Tourniquet Deflation-induced Hypotension and Tachycardia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Go-Shine Huang, Tri-Service General Hospital
ClinicalTrials.gov Identifier:
NCT01592669
First received: March 30, 2012
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

Background:

The pneumatic tourniquet is frequently used in total knee arthroplasty. Tourniquet deflation may result in hypotension and tachycardia caused by the rapid shift of blood volume back to the ischemic limb and a decrease in cardiac preload. Passive leg raising (PLR) represents a "self-volume challenge" that can result in an increase in preload. Such a PLR-induced increase in preload was hypothesized to attenuate the decrease in preload resulting from tourniquet deflation. This study was designed to evaluate the effect of PLR on hypotension and tachycardia following tourniquet deflation.

Methods:

Seventy patients who underwent unilateral total knee arthroplasty were assigned to either the bilateral PLR group (n = 35) or the control group (n = 35), in a prospective randomized trial. The patients' blood pressure and heart rate were measured before, during, and after tourniquet deflation.


Condition Intervention
Hypotension
Tachycardia
Procedure: passive leg raising

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect of Passive Leg Raising or Experimental Clinical Practices on the Prevention of Hypotension Following Tourniquet Release in Total Knee Arthroplasty Patients

Resource links provided by NLM:


Further study details as provided by Tri-Service General Hospital:

Primary Outcome Measures:
  • Change from Baseline in Blood pressure [ Time Frame: Baseline and 60 min ] [ Designated as safety issue: Yes ]
    The patients' blood pressure was measured before, during, and after tourniquet deflation. Step 1 (T1-T5), measurements were taken at 30, 15, 10, 5, and 1 min before bilateral passive leg raising (PLR). Step 2 (T6-T7), measurements were taken 2 and 4 min after initiation of PLR. Step 3 (T8-T10), measurements were taken at 2, 4, and 6 min after tourniquet deflation. Step 4 (T11-T17), measurements were obtained 1, 3, 5, 10, 15, 30, and 60 min later. Hemodynamic measurements and change were analyzed over time by comparing the T6-T17 measurements to the T5 measurements in each group.


Secondary Outcome Measures:
  • Heart rate [ Time Frame: up to 60 min ] [ Designated as safety issue: Yes ]
    The patients' heart rate was measured before, during, and after tourniquet deflation. Step 1 (T1-T5), measurements were taken at 30, 15, 10, 5, and 1 min before bilateral passive leg raising (PLR). Step 2 (T6-T7), measurements were taken 2 and 4 min after initiation of PLR. Step 3 (T8-T10), measurements were taken at 2, 4, and 6 min after tourniquet deflation. Step 4 (T11-T17), measurements were obtained 1, 3, 5, 10, 15, 30, and 60 min later.Hemodynamic measurements and change were analyzed over time by comparing the T6-T17 measurements to the T5 measurements in each group.


Enrollment: 35
Study Start Date: September 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: passive leg group
bilateral PLR was achieved by raising the patient's legs to a 45 angle.
Procedure: passive leg raising
bilateral PLR was achieved by raising the legs of patient
Other Name: PLR
No Intervention: control
supine baseline position

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with degenerative joint disease of the knee scheduled to receive unilateral total knee arthroplasty

Exclusion Criteria:

  • bilateral total knee arthroplasty, previous knee surgery, cardiac arrhythmia, uncontrolled hypertension (systolic blood pressure > 170 mmHg), presence of a known aortic aneurysm, recent stroke or myocardial infarction, unstable angina pectoris, New York Heart Association functional class III or IV, and American Society of Anesthesiologists physical status IV to V
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592669

Locations
Taiwan
Nei-Hu
Taipei, Taiwan, 11490
Sponsors and Collaborators
Tri-Service General Hospital
Investigators
Principal Investigator: Go-shine Huang, MD Department of Anesthesiology, Tri-Service General Hospital, National Defense Medical Center
  More Information

No publications provided by Tri-Service General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Go-Shine Huang, Clinical assistant professor. Doctor of anesthesiology and critical care, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT01592669     History of Changes
Other Study ID Numbers: TSGH-C101-105
Study First Received: March 30, 2012
Last Updated: May 4, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Tri-Service General Hospital:
Passive leg raising, blood pressure, heart rate

Additional relevant MeSH terms:
Hypotension
Tachycardia
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014