Study Stopped
This study was stopped because of lack of posterior only major spine surgeries.
Arterial Pulse Waveform Contour Analysis for Intraoperative Goal Directed Therapy in Major Spine Surgery
Evaluation of the Use of Arterial Pulse Waveform Contour Analysis for Goal Directed Therapy in Patients Undergoing Major Spine Surgery
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2010
CompletedFirst Posted
Study publicly available on registry
May 17, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedApril 12, 2012
April 1, 2012
1.3 years
May 13, 2010
April 11, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of the Use of Arterial Pulse Waveform Contour Analysis for Goal Directed Therapy in Patients Undergoing Major Spine Surgery
time in days from the end of surgery to hospital discharge
From end of surgey to approximately 1 week
Secondary Outcomes (1)
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
Study Arms (2)
Standard fluid management
NO INTERVENTIONStandard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team
Vigileo model number MHM1
OTHERPulse 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%.
Interventions
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 Criteria
You may qualify if:
- Adult patients scheduled for major spine surgery at LLUMC University Hospital will be eligible for participation in this study
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Loma Linda University
Loma Linda, California, 92354, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard L Applegate, M.D.
Loma Linda University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 13, 2010
First Posted
May 17, 2010
Study Start
December 1, 2010
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
April 12, 2012
Record last verified: 2012-04