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

Surgical Procedures, Operative Clinical Trial

Official title:

Evaluation of the Use of Arterial Pulse Waveform Contour Analysis for Goal Directed Therapy in Patients Undergoing Major Spine Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01124474
• Other study ID #: 5100118
• Status: Terminated
• Phase: N/A
• First received: May 13, 2010
• Last updated: April 11, 2012
• Start date: December 2010
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Surgical Procedures, Operative

Intervention

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%.

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No