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

Not Applicable

Completed

• Conditions: Surgical Procedures, Operative
• Interventions: Device: Vigileo

• Registration Number: NCT01082614
• 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 shorter hospital stay after surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-03-03
• Study First Submitted QC: 2010-03-05
• Study First Posted: 2010-03-08
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Results First Submitted: 2015-03-17
• Results First Submitted QC: 2015-03-23
• Results First Posted: 2015-04-02
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• All patients requiring elective or semi-elective major abdominal surgery will be assessed for eligibility.

Exclusion Criteria

• Age under 18 years old,
• Coagulopathy,
• Significant renal/hepatic dysfunction (creatine >50% or liver enzymes > 50% of normal values),
• Congestive heart failure,
• Cardiac arrhythmias producing irregular rhythms, and
• Patient choice.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Goal directed therapy	Vigileo	Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis

Primary Outcome Measures

Name	Time	Method
Length of Postoperative Hospital Stay	within one month	time in days from end of surgery to hospital discharge

Secondary Outcome Measures

Name	Time	Method
Quality of Recovery Score on Postoperative Day 2	Postoperative day 2	Measure of quality of recovery (QOR) using scoring system in 9 domains as assessed by patient and nursing team. Score for each domain is assigned as 0, 1 or 2; the sum of scores is the QOR score with a range of 0 to 18. Higher scores indicate better quality of recovery after surgery.
Quality of Recovery Score on Postoperative Day 4	Postoperative day 4	Measure of quality of recovery (QOR) using scoring system in 9 domains as assessed by patient and nursing team. Score for each domain is assigned as 0, 1 or 2; the sum of scores is the QOR score with a range of 0 to 18. Higher scores indicate better quality of recovery following surgery.

Trial Locations

Locations (1)

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