Hypotension Prediction Index for Shoulder Surgery in Beach Chair.

NCT ID: NCT06120296

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2025-05-31

Brief Summary

The beach chair position is the most commonly used position during shoulder surgery and offers the surgeon numerous advantages over the lateral decubitus position. However, the beach chair position can also lead to hemodynamic changes, including hypotension and cerebral hypoperfusion. It is therefore the anesthesiologist's job to prevent hypotension during the procedure.

The Acumen Hypotension Predictor Index or HPI for short is a software program that can predict the occurrence of low blood pressure during surgery shortly before it occurs. Studies have already demonstrated the effectiveness of HPI in various operations, where hypotension is defined as a mean arterial blood pressure < 65mmHg for at least 1 minute. To our knowledge, the low blood pressure prediction index has not yet been investigated for the prevention of low blood pressure in shoulder surgery in the beach chair position.

The HPI is built into a monitor that is switched on in addition to the standard monitoring for monitoring blood pressure, pulse, saturation, among other things. The monitor gives a signal when an episode of low blood pressure will occur within 15 minutes. This gives the anesthesiologist the opportunity to anticipate in time so that the occurrence of low blood pressure can be avoided.

Goal The aim of this study is to evaluate the efficacy of the HPI in predicting and reducing the incidence of hypotension during shoulder surgery in the beach chair position.

Procedure A total of 144 patients will participate in this study. Patients will be randomized to the intervention group or the control group according to a 1:1 allocation. In addition to standard monitoring, the HPI monitor will be turned on for all patients. For patients in the control group, the HPI monitor screen will be blinded and the alarms muted.

Patients between 18 and 85 years of age with a BMI ≤ 40 kg/m2 undergoing elective shoulder surgery are eligible for the study.

Conditions

Hypotension During Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

control group

In the blinded HPI group (the control group) the arterial waveform and pressure will be presented on a Philips patient monitor (the standard monitor), while the display of the hemosphere monitor shall be covered and the alarms will be silenced.

Group Type: NO_INTERVENTION

No interventions assigned to this group

intervention group

In the unblinded HPI group (the intervention group), the arterial waveform and pressure will be displayed on the anesthesia monitor and the HPI on the Hemosphere monitor of Edwards Lifesciences (the study monitor).

Group Type: EXPERIMENTAL

Acumen Hypotension prediction Index software

Intervention Type: DEVICE

In the unblinded HPI group (the intervention group), the arterial waveform and pressure will be displayed on the anesthesia monitor and the HPI on the Hemosphere monitor of Edwards Lifesciences (the study monitor).

Interventions

Acumen Hypotension prediction Index software

In the unblinded HPI group (the intervention group), the arterial waveform and pressure will be displayed on the anesthesia monitor and the HPI on the Hemosphere monitor of Edwards Lifesciences (the study monitor).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• BMI < 40 kg/m2
• Patient can give informed consent
• ASA I-IV
• Invasive blood monitoring
• General anesthesia combined with interscalene block

Exclusion Criteria

• - Refusal of participation
• Hypotension before surgery (MAP< 65 mmHg)
• History of stroke
• Dementia
• Contra-indication for interscalene block
• Contra-indication for general anesthesia
• Dialysis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geertrui Dewinter

OTHER

Sponsor Role: lead

Responsible Party

Geertrui Dewinter

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Anesthesie Research

Leuven, , Belgium

Site Status: RECRUITING

Countries

Belgium

Facility Contacts

Dewinter, PhD

Role: primary

geertrui.dewinter@uzleuven.be

+3216344270

Other Identifiers

GDW 10/2022

Identifier Type: -

Identifier Source: org_study_id