The Clinical Effects of Perioperative Use of the Hypotension Prediction Index
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypotension During Surgery
- Sponsor
- Radboud University Medical Center
- Enrollment
- 50
- Primary Endpoint
- Time Weighted Average of hypotension
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Time Weighted Average of hypotension
Time Frame: 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 Outcomes
- Lactate("at the start of surgery", "at PACU admission", "day after surgery at 06.00hours")
- Total amount of administered fluids(During surgery and in the 24 hours following surgery)
- Eligibility for discharge to the ward on the day after surgery(During morning rounds the day after surgery (approximately at 10.00hours))
- Frequency and duration of hypotension(During surgery and in the 24 hours following surgery)
- Number and type of complications in the first 30 days after surgery(30 days after surgery)
- Glomerular filtration rate("at the start of surgery", "at PACU admission", "day after surgery at 06.00hours")
- Frequency and duration of hypertension(During surgery and in the 24 hours following surgery)
- Total administration of vasopressors(During surgery and in the 24 hours following surgery)
- Total administration of inotropy(During surgery and in the 24 hours following surgery)