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Intraoperative Fluid Management During Complex Spine Surgery Using the FloTrac System

IRB Number: 29060
inactive

August 27, 2009

Institutional Review Board, Hospital for Special Surgery

The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.

For further information, see Understanding Clinical Trials/Research Studies.

Principal Investigator

Michael K. Urban, MD

Co-Investigators

Stavros G. Memtsoudis, MD
Michael C. Ho, MD
Frederico P. Girardi, MD
Andrew A. Sama, MD
Stephen N. Harris, MD
Frank P. Cammisa, Jr., MD
Dorothy Marcello, BA.

Summary

Fifteen patients for thoraco-lumbar spinal fusions.  All study data will be collected intraoperatively.

Inclusion/Exclusion Criteria

Patients 18 years or older presenting for multiple level (>5) posterior thoraco-lumbar spinal fusions are included. 
Patients with severe pulmonary hypertension, right ventricular failure, aortic insufficiency and/or stenosis will be excluded.

Contact Information

Dorothy Marcello, BA
fordc@hss.edu
212.606.1206