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

Loma Linda University (LLU)

Status: Terminated

Conditions: Surgical Procedures, Operative

Treatments: Other: goal directed therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01124474

5100118

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5 participants in 2 patient groups

Standard fluid management

No Intervention group

Description:

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

Vigileo model number MHM1

Other group

Description:

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%.

Treatment:

Other: goal directed therapy