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Arterial Pulse Waveform Contour Analysis for Intraoperative Goal Directed Therapy in Major Spine Surgery

This study has been terminated.
(This study was stopped because of lack of posterior only major spine surgeries.)
Sponsor:
Information provided by (Responsible Party):
Richard Applegate, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01124474
First received: May 13, 2010
Last updated: April 11, 2012
Last verified: April 2012
History of Changes
  Purpose

This study evaluates whether using information from a special arterial blood pressure monitor to guide how much fluid is given during surgery changes how long a patient stays in the hospital after the surgery. There is scientific evidence from using similar information from different devices that this technique might allow us to do a better job giving fluids during surgery and that this may be associated with a shorter hospital stay after surgery.


Condition Intervention
Surgical Procedures, Operative
 Other: goal directed therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of the Use of Arterial Pulse Waveform Contour Analysis for Goal Directed Therapy in Patients Undergoing Major Spine Surgery

Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Evaluation of the Use of Arterial Pulse Waveform Contour Analysis for Goal Directed Therapy in Patients Undergoing Major Spine Surgery [ Time Frame: From end of surgey to approximately 1 week ] [ Designated as safety issue: No ]
    time in days from the end of surgery to hospital discharge


Secondary Outcome Measures:
  • Evaluation of the Use of Arterial Pulse Waveform Contour Analysis for Goal Directed Therapy in Patients Undergoing Major Spine Surgery [ Time Frame: from the end of surgery to approximately 1 month ] [ Designated as safety issue: No ]
    The measure of quality of recovery using scoring system; assessed by patient and nursing team


Enrollment: 5
Study Start Date: December 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard fluid management
Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team
Vigileo model number MHM1
Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV>12%.
 Other: goal directed therapy
Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV>12%.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients scheduled for major spine surgery at LLUMC University Hospital will be eligible for participation in this study

Exclusion Criteria:

  • age under 18yr,
  • coagulopathy, significant renal or hepatic dysfunction (creatinine or liver enzymes > 50% above normal values),
  • congestive heart failure,
  • cardiac arrhythmias producing irregular rhythms, and patient refusal.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124474

Locations
United States, California
Loma Linda University
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Richard L Applegate, M.D. Loma Linda University
  More Information

No publications provided

Responsible Party: Richard Applegate, MD, Loma Linda University
ClinicalTrials.gov Identifier: NCT01124474     History of Changes
Other Study ID Numbers: 5100118
Study First Received: May 13, 2010
Last Updated: April 11, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 22, 2013