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

Not Applicable

Terminated

• Conditions: Surgical Procedures, Operative
• Interventions: Other: goal directed therapy

• Registration Number: NCT01124474
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-13
• Study First Submitted QC: 2010-05-14
• Study First Posted: 2010-05-17
• Study Start: 2010-12
• Status Verified: 2012-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Last Update Submitted: 2012-04-11
• Last Update Posted: 2012-04-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vigileo model number MHM1	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

Name	Time	Method
Evaluation of the Use of Arterial Pulse Waveform Contour Analysis for Goal Directed Therapy in Patients Undergoing Major Spine Surgery	From end of surgey to approximately 1 week	time in days from the end of surgery to hospital discharge

Secondary Outcome Measures

Name	Time	Method
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	The measure of quality of recovery using scoring system; assessed by patient and nursing team

Trial Locations

Locations (1)

Loma Linda University; 🇺🇸 Loma Linda, California, United States