NCT05844774

Post Anaesthesia Care Hypotension Prevention

The Clinical Effects of Perioperative Use of the Hypotension Prediction Index

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypotension During Surgery

Interventions

Type	Name	Description
DEVICE	HPI (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%.
DEVICE	Treatment of hypotension following standard of care	Patients receive standard of care treatment for hypotension, with a goal-mean arterial pressure (MAP) of 65mmHg.

Timeline

• Start date: 2023-05-22
• Primary completion: 2024-06-01
• Completion: 2024-08-01
• First posted: 2023-05-06
• Last updated: 2023-05-06