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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Surgical Procedures, Operative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard fluid management

Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team

Group Type NO_INTERVENTION

No interventions assigned to this group

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%.

Group Type OTHER

goal directed therapy

Intervention Type OTHER

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%.

Interventions

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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%.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No