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

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ClinicalTrials.gov Identifier: NCT01124474
Recruitment Status : Terminated (This study was stopped because of lack of posterior only major spine surgeries.)
First Posted : May 17, 2010
Last Update Posted : April 12, 2012
Sponsor:
Information provided by (Responsible Party):
Richard Applegate, Loma Linda University

Brief Summary:
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 or disease Intervention/treatment Phase
Surgical Procedures, Operative Other: goal directed therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : December 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Arm Intervention/treatment
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%.



Primary Outcome Measures :
  1. 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 ]
    time in days from the end of surgery to hospital discharge


Secondary Outcome Measures :
  1. 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 ]
    The measure of quality of recovery using scoring system; assessed by patient and nursing team



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Richard Applegate, MD, Loma Linda University
ClinicalTrials.gov Identifier: NCT01124474     History of Changes
Other Study ID Numbers: 5100118
First Posted: May 17, 2010    Key Record Dates
Last Update Posted: April 12, 2012
Last Verified: April 2012