Passive Leg Raising Attenuates and Delays Tourniquet Deflation-induced Hypotension and Tachycardia
This study has been completed.
Sponsor:
Tri-Service General Hospital
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
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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
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
| 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 Vascular Diseases Cardiovascular Diseases |
Arrhythmias, Cardiac Heart Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013