Clinical trial NCT05844774: Post Anaesthesia Care Hypotension Prevention
Official title: The Clinical Effects of Perioperative Use of the Hypotension Prediction Index
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypotension During Surgery
Keywords: Laparotomy
Hypotension
Goal Directed Therapy
Post-operative
Prediction
Artificial intelligence
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2023-05-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1 control group, 1 intervention group without cross-over
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Time Weighted Average of hypotension
timeFrame: During the accumulative duration of surgery and PACU admission
Secondary outcomes:
measure: Frequency and duration of hypotension
timeFrame: During surgery and in the 24 hours following surgery
measure: Frequency and duration of hypertension
timeFrame: During surgery and in the 24 hours following surgery
measure: Total amount of administered fluids
timeFrame: During surgery and in the 24 hours following surgery
measure: Total administration of vasopressors
timeFrame: During surgery and in the 24 hours following surgery
measure: Total administration of inotropy
timeFrame: During surgery and in the 24 hours following surgery
measure: Eligibility for discharge to the ward on the day after surgery
timeFrame: During morning rounds the day after surgery (approximately at 10.00hours)
measure: Lactate
timeFrame: "at the start of surgery", "at PACU admission", "day after surgery at 06.00hours"
measure: Glomerular filtration rate
timeFrame: "at the start of surgery", "at PACU admission", "day after surgery at 06.00hours"
measure: Number and type of complications in the first 30 days after surgery
timeFrame: 30 days after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Coordinating Investigator
name: Van Eijk
role: PRINCIPAL_INVESTIGATOR
References: