N/A
N=46
Arterial Pulse Waveform Contour Analysis for Intraoperative Goal Directed Therapy in Major Abdominal Surgery
Surgical Procedures, Operative
Bottom Line
View on ClinicalTrials.gov: NCT01082614 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Length of Postoperative Hospital Stay — 7.5; 5.0 Days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vigileo (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Loma Linda University
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Postoperative Hospital Stay |
7.5; 5.0 | — |
| SECONDARY Quality of Recovery Score on Postoperative Day 2 |
15.0; 16.0 | — |
| SECONDARY Quality of Recovery Score on Postoperative Day 4 |
16.5; 18.0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01082614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.