Surgical Procedures, Operative
Conditions
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.
Interventions
DEVICEVigileo
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%.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Postoperative Hospital Stay | within one month | time in days from end of surgery to hospital discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Fluid Management Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team | 20 |
| Goal Directed Therapy Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis
Vigileo: 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%. | 18 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 4 |
| Overall Study | Equipment Malfunction | 0 | 1 |
| Overall Study | Physician Decision | 2 | 0 |
Baseline characteristics
| Characteristic | Goal Directed Therapy | Standard Fluid Management | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 12 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 8 Participants | 21 Participants |
| Age, Continuous | 53.5 years STANDARD_DEVIATION 16.2 | 64.4 years STANDARD_DEVIATION 15.8 | 58.95 years STANDARD_DEVIATION 16 |
| Region of Enrollment United States | 18 participants | 20 participants | 38 participants |
| Sex: Female, Male Female | 13 Participants | 14 Participants | 27 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 18 |
| serious Total, serious adverse events | 0 / 20 | 0 / 18 |
Outcome results
Primary
Length of Postoperative Hospital Stay
time in days from end of surgery to hospital discharge
Time frame: within one month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Fluid Management | Length of Postoperative Hospital Stay | 7.5 Days |
| Goal Directed Therapy | Length of Postoperative Hospital Stay | 5.0 Days |
Secondary
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.
Time frame: Postoperative day 2
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Fluid Management | Quality of Recovery Score on Postoperative Day 2 | 15.0 units on a scale |
| Goal Directed Therapy | Quality of Recovery Score on Postoperative Day 2 | 16.0 units on a scale |
Secondary
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.
Time frame: Postoperative day 4
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Fluid Management | Quality of Recovery Score on Postoperative Day 4 | 16.5 units on a scale |
| Goal Directed Therapy | Quality of Recovery Score on Postoperative Day 4 | 18.0 units on a scale |