Abdominal Laparoscopic and/or Robotic Surgery
Conditions
Keywords
Fluid therapy, Hemodynamic flow monitoring, Closed-loop system, Goal-directed fluid therapy, Anesthesiology
Brief summary
The aim of this study is to compare hemodynamic variables and outcome in patients undergoing laparoscopic and/or robotic elective abdominal surgery. Patients will receive either an automated closed-loop goal-directed fluid therapy (GDFT) guided by non-invasive flow monitoring or a restrictive fluid therapy of 4ml/kg/h.
Detailed description
Perioperative fluid management is a topic of much debate that has intensified over recent years. Studies have shown improved postoperative outcomes with restricted fluid administration in the perioperative period for moderate risk abdominal surgery. They concluded that in patients undergoing elective abdominal surgery, intraoperative restrictive fluid management was associated with a reduction in postoperative morbidity and shortened hospital stay. Current standard practice is a crystalloid based fluid therapy guided by static hemodynamic parameters such as heart rate, blood pressure, and diuresis. However, several studies have criticized this cookbook approach and recommend tailoring management to specific physiologic dynamic endpoints such as stroke volume variation and cardiac output using a flow monitoring device. Our team has demonstrated that the use of a closed-loop system is feasible and allows precise titration of fluid administration in abdominal and vascular surgery using either a minimally or a non-invasive monitoring system. Goal: This study compares hemodynamic variables and outcome in patients who will receive either automated closed-loop fluid therapy guided by non-invasive flow monitoring or restrictive fluid therapy of 4ml/kg/h. Both groups consist of the same population undergoing laparoscopic and/or robotic surgery. Hypothesis: A closed-loop assisted intraoperative GDFT when compared to restrictive fluid therapy will provide better hemodynamic variables.
Interventions
DEVICEClosed-Loop GDFT
Patients receive fluids in the form of 100ml boluses of crystalloid (Plasmalyte) over 6 minutes via an automated closed-loop goal-directed fluid therapy (GDFT) system guided by non-invasive flow monitoring (Clearsight system). Additional boluses of colloid or crystalloid can be administered under the attending anesthesiologist's discretion (e.g. to compensate blood loss) .
Patients receive fluids (Plasmalyte) via a restrictive approach with a baseline of of 4ml/kg/h. Additional boluses of colloid or crystalloid can be administered under the attending anesthesiologist's discretion (e.g. to compensate blood loss) .
Sponsors
Erasme University Hospital
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
* Laparoscopic and/or robotic elective abdominal surgery( colorectal, gynecological, urological)
Exclusion criteria
* Intraoperative invasive monitoring (arterial line) * Open colorectal surgery (laparotomy) * Emergency surgery * Expected intraoperative blood loss greater than 1000ml * Arrhythmia (e.g. atrial fibrillation)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preload independent state | 6 hours | The percentage intraoperative time spent with stroke volume variation \< 13% and/or cardiac index \> 2.4 L/min/m2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional fluids administered intraoperatively | 6 hours | — |
| Number of closed-loop override by the attending anesthesiologist | 6 hours | — |
| Hospital length of stay | up to 90 days post surgery | — |
| Postoperative complications | up to 90 days after hospitalization | Major complications include cardiac (acute coronary syndrome/ arrhythmia), pulmonary (embolism/edema), gastrointestinal (bowel and surgical anastomotic leak/internal or external fistulas/peritoneal effusions), renal (renal failure requiring dialysis), infectious (peritonitis/ sepsis), coagulation (bleeding), wound dehiscence, stroke, reoperation, readmission, and death. Minor complications include unplanned ICU admission, pneumonia/pleural effusion, deep venous thrombosis, paralytic ileus, renal insufficiency, infection (superficial wound infection/fever/urinary infection) and confusion/delirium. |
Countries
Belgium
Outcome results
None listed