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Hypotension Prediction Index for Shoulder Surgery in Beach Chair.

NCT06120296 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2023-11-07

No results posted yet for this study

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

Interventions

DEVICE

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).

Sponsors & Collaborators

  • Geertrui Dewinter

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2024-12-31
Completion
2025-05-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06120296 on ClinicalTrials.gov