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

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 Overview

• Status: Terminated
• Conditions: Surgical Procedures, Operative
• Intervention / Treatment: Other: goal directed therapy

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard fluid management; Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team
Other: 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%.	Other: 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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the Use of Arterial Pulse Waveform Contour Analysis for Goal Directed Therapy in Patients Undergoing Major Spine Surgery	The measure of quality of recovery using scoring system; assessed by patient and nursing team	from the end of surgery to approximately 1 month

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Richard L Applegate, M.D., Loma Linda University

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: May 13, 2010
• First Submitted That Met QC Criteria: May 14, 2010
• First Posted (Estimate): May 17, 2010

Study Record Updates

• Last Update Posted (Estimate): April 12, 2012
• Last Update Submitted That Met QC Criteria: April 11, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 5100118