Evaluation of the Use of Arterial Pulse Waveform Contour Analysis for Goal Directed Therapy in Patients Undergoing Major Spine Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Loma Linda University
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Evaluation of the Use of Arterial Pulse Waveform Contour Analysis for Goal Directed Therapy in Patients Undergoing Major Spine Surgery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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%.
Intervention: goal directed therapy (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Evaluation of the Use of Arterial Pulse Waveform Contour Analysis for Goal Directed Therapy in Patients Undergoing Major Spine Surgery(from the end of surgery to approximately 1 month)
Investigators
Richard Applegate
MD
Loma Linda University