Hypotension During Surgery
Conditions
Keywords
Laparotomy, Hypotension, Goal Directed Therapy, Post-operative, Prediction, Artificial intelligence
Brief summary
The goal of this clinical trial is to investigate if the use of the hypotension prediction index during the perioperative period leads to a decrease in hypotension both during and after surgery (24 hrs) in adults undergoing major abdominal surgery. The main question this trial aims to answer is: • Does the use of the hypertension prediction index (HPI) decrease hypotension during surgery and in the post-operative period? During and after their surgery, participants in the intervention group will be treated according to the HPI-algorithm. Participants in the control group will be treated following the standard of care.
Detailed description
Rationale: Hypotension during and after surgery is associated with serious complications. Using a machine learning algorithm, hypotension can be accurately predicted. Edwards Lifesciences developed this algorithm, called Hypotension Prediction Index and integrated this in their hemodynamical monitors. Recent studies have shown a decrease in intraoperative hypotension when using the hypotension prediction index. Objective: To investigate if the use of the hypotension prediction index during the perioperative period leads to a decrease in hypotension (time weighted average) both during and after surgery (24 hrs). Intervention: Patients in the intervention group will be treated using the hypotension prediction index algorithm to prevent hypotension. In case of actual hypotension the treatment thereof is at the discretion of the anaesthesiologist. Main study parameters/endpoints: The decrease in time weighted average of hypotension in the peri- and post-operative period.
Interventions
DEVICEHPI (using HemoSphere) - guided algorithm
Treatment of hypotension guided by the hypotension prediction index. Patients will receive treatment following the predetermined HPI-algorithm when the HPI exceeds 85%.
DEVICETreatment of hypotension following standard of care
Patients receive standard of care treatment for hypotension, with a goal-mean arterial pressure (MAP) of 65mmHg.
Sponsors
Edwards Lifesciences
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Open label clinical trial
Intervention model description
1 control group, 1 intervention group without cross-over
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \> 18 years old * Patients planned to undergo laparotomy surgery * Patients that will receive an invasive arterial catheter as part of their procedure * Patients that are planned to go to the post anaesthetic care unit (PACU) post-operatively
Exclusion criteria
* Patients with known arrythmias * Patients with known severe heart valve disease * Patients with the need for dialysis * Clamping of the aorta or Pringle's manoeuvre during surgery * Emergency procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Weighted Average of hypotension | During the accumulative duration of surgery and PACU admission | Time Weighted Average (TWA) is measured as (depth of hypotension in mmHg below a MAP op 65mmHg x time in minutes spent below a MAP of 65mmHg) ÷ total duration of surgery/PACU admission in minutes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and duration of hypertension | During surgery and in the 24 hours following surgery | Defined as MAP\>100mmHg for at least 1 minute |
| Total amount of administered fluids | During surgery and in the 24 hours following surgery | Total amount of administered fluids (absolute, ml/kg/min, input/output ratio) |
| Total administration of vasopressors | During surgery and in the 24 hours following surgery | Total administration of vasopressors (mcg/kg/min) |
| Total administration of inotropy | During surgery and in the 24 hours following surgery | Total administration of inotropy (mcg/kg/min) |
| Frequency and duration of hypotension | During surgery and in the 24 hours following surgery | Defined as MAP\<65mmHg for at least 1 minute |
| Lactate | at the start of surgery, at PACU admission, day after surgery at 06.00hours | Lactate level as measured in arterial blood gas |
| Glomerular filtration rate | at the start of surgery, at PACU admission, day after surgery at 06.00hours | Glomerular filtration rate as measured in arterial blood gas |
| Number and type of complications in the first 30 days after surgery | 30 days after surgery | Number and type of complications in the first 30 days after surgery |
| Eligibility for discharge to the ward on the day after surgery | During morning rounds the day after surgery (approximately at 10.00hours) | Eligibility defined as yes or no |
Contacts
Primary ContactVan Eijk
Backup ContactSieffers
Outcome results
None listed