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

NCT01144546 | Completed Phase 2

• 1 other identifier: H-0809-037-256
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Heart Disease; Cardiac Valve Disease

Keywords

Passive leg raising; FloTrac/Vigileo; Anesthesia hypotension

Outcome Measures

Primary Outcomes (1)

• 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

  30 min around passive leg raising test

Study Arms (1)

Passive Leg Raising

EXPERIMENTAL

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

Procedure: passive leg raising (45 degree leg elevation for 1-2 min)

Interventions

passive leg raising (45 degree leg elevation for 1-2 min) PROCEDURE

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)

Also known as: PLR

Passive Leg Raising

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients undergoing elective cardiac surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Myocardial Ischemia; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Yunseok Jeon, M.D

  Seoul National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: June 15, 2010
• Study Start: August 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: June 15, 2010

Record last verified: 2010-06

Locations

KR (1)