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

NCT01592669 | Completed DMC

• 1 other identifier: TSGH-C101-105
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypotension; Tachycardia

Keywords

Passive leg raising, blood pressure, heart rate

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Blood pressure

  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.

  Baseline and 60 min

Secondary Outcomes (1)

• Heart rate

  up to 60 min

Study Arms (2)

passive leg group

EXPERIMENTAL

bilateral PLR was achieved by raising the patient's legs to a 45 angle.

Procedure: passive leg raising

control

NO INTERVENTION

supine baseline position

Interventions

passive leg raising PROCEDURE

bilateral PLR was achieved by raising the legs of patient

Also known as: PLR

passive leg group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Nei-Hu

Taipei, 11490, Taiwan

Location

Related Publications (1)

• Huang GS, Wang CC, Hu MH, Cherng CH, Lee MS, Tsai CS, Chan WH, Hsieh XX, Lin LC. Bilateral passive leg raising attenuates and delays tourniquet deflation-induced hypotension and tachycardia under spinal anaesthesia: a randomised controlled trial. Eur J Anaesthesiol. 2014 Jan;31(1):15-22. doi: 10.1097/EJA.0b013e32836286e3.

  PMID: 23812622 DERIVED

MeSH Terms

Conditions

Hypotension; Tachycardia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Go-shine Huang, MD

  Department of Anesthesiology, Tri-Service General Hospital, National Defense Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor. Doctor of anesthesiology and critical care

Study Record Dates

• First Submitted: March 30, 2012
• First Posted: May 7, 2012
• Study Start: September 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: May 7, 2012

Record last verified: 2012-05

Locations

TW (1)