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

Study Overview
=================
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.

Official Title
-----------------
Evaluation of the Use of Arterial Pulse Waveform Contour Analysis for Early Goal Directed Therapy in Patients Undergoing Major Abdominal Surgery

Conditions
-----------------
Surgical Procedures, Operative

Intervention / Treatment
-----------------
* Device: Vigileo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard fluid management<br>standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team | |
| Experimental: Goal directed therapy<br>Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis | Device: Vigileo<br>* 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%.<br>* Other names: Vigileo model number MHM1;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Postoperative Hospital Stay | time in days from end of surgery to hospital discharge | within one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery Score on 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. | Postoperative day 2 | 
| Quality of Recovery Score on 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. | Postoperative day 4 |