Post Anaesthesia Care Hypotension Prevention (PACH-1)

The Clinical Effects of Perioperative Use of the Hypotension Prediction Index

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypotension During Surgery
• Intervention / Treatment: Device: HPI (using HemoSphere) - guided algorithm; Device: Treatment of hypotension following 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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Van Eijk; Phone Number: 0624501517; Email: lucas.vaneijk@radboudumc.nl
• Study Contact Backup: Name: Sieffers; Phone Number: 0646306609; Email: matthijs.sieffers@radboudumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HPI-intervention algorithm; 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.	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%.
Other: Control group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Weighted Average of hypotension	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)	During the accumulative duration of surgery and PACU admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and duration of hypotension	Defined as MAP<65mmHg for at least 1 minute	During surgery and in the 24 hours following surgery
Frequency and duration of hypertension	Defined as MAP>100mmHg for at least 1 minute	During surgery and in the 24 hours following surgery
Total amount of administered fluids	Total amount of administered fluids (absolute, ml/kg/min, input/output ratio)	During surgery and in the 24 hours following surgery
Total administration of vasopressors	Total administration of vasopressors (mcg/kg/min)	During surgery and in the 24 hours following surgery
Total administration of inotropy	Total administration of inotropy (mcg/kg/min)	During surgery and in the 24 hours following surgery
Eligibility for discharge to the ward on the day after surgery	Eligibility defined as yes or no	During morning rounds the day after surgery (approximately at 10.00hours)
Lactate	Lactate level as measured in arterial blood gas	"at the start of surgery", "at PACU admission", "day after surgery at 06.00hours"
Glomerular filtration rate	Glomerular filtration rate as measured in arterial blood gas	"at the start of surgery", "at PACU admission", "day after surgery at 06.00hours"
Number and type of complications in the first 30 days after surgery	Number and type of complications in the first 30 days after surgery	30 days after surgery

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Edwards Lifesciences
• Investigators: Principal Investigator: Van Eijk, Coordinating Investigator

Study record dates

Study Major Dates

• Study Start (Anticipated): May 22, 2023
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Estimate): May 4, 2023

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Hypotension; Post-operative; Artificial intelligence; Prediction; Laparotomy; Goal Directed Therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: NL81361.091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No