Hypotension Prediction Index for Shoulder Surgery in Beach Chair.

Not Applicable

Recruiting

• Conditions: Hypotension During Surgery
• Interventions: Device: Acumen Hypotension prediction Index software

• Registration Number: NCT06120296
• Lead Sponsor: Geertrui Dewinter

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-30
• Study First Submitted: 2023-10-12
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-06
• Last Update Submitted: 2023-11-06
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07
• Primary Completion: 2024-12-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	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).

Primary Outcome Measures

Name	Time	Method
Time-weighted average MAP< than 65 mmHg	during surgery	Calculated as depth of hypotension below a MAP of 65 mmHg x time spent below a MAP of 65 mmHg (in minutes) divided by total duration of anesthesia (in minutes))

Trial Locations

Locations (1)

Anesthesie Research; 🇧🇪 Leuven, Belgium