Post Anaesthesia Care Hypotension Prevention (PACH-1)

Radboud University Medical Center

Status: Not yet enrolling

Conditions: Hypotension During Surgery

Treatments: Device: Treatment of hypotension following standard of care; Device: HPI (using HemoSphere) - guided algorithm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05844774

NL81361.091

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

HPI-intervention algorithm

Experimental group

Description:

In the intervention group the HemoSphere screen is visible and the anesthesiologist and PACU personal are instructed to follow the algorithm (chapter 4) in case of a HPI \>85%. The purpose of the alarm at 85% and the presented algorithm is to prevent hypotension. If hypotension occurs, it should be treated as according to the standard of care.

Treatment:

Device: HPI (using HemoSphere) - guided algorithm

Control group

Other group

Description:

Patients in the control group are connected to the HemoSphere monitor to evaluate the TWA of hypotension in this group. The screen is not visible to the anesthesiologist or PACU personal and the alarm is set silent. It will be explained to the anesthesiologist and PACU personal that the patients are included to this study and that a blood pressure with a MAP of 65 mmHg should be monitored.

Treatment:

Device: Treatment of hypotension following standard of care