Adverse Event Prediction in Geriatric Patients in the ED With Ultrasound

Completed

• Conditions: Adverse Event; Frailty

• Registration Number: NCT05369962
• Lead Sponsor: University Medical Center Groningen

Brief Summary

The aim of this study is to evaluate whether ultrasound measurements of the Qcsa can be utilized to identify older patients who are at risk for functional decline, ED revisit or death.

Detailed Description

Background:

Older people visit the Emergency Department (ED) more frequently then younger people and have a higher risk of functional decline, ED revisit or death. Several screening tools (such as the Dutch safety management system (VMS) and Acutely Presenting Older Patient (APOP)) have been developed to identify patients at the highest risk of adverse outcomes. Almost all require adequate communication with the patient, which is not always possible, for example when elderly patients present with a delirium. Point of Care Ultrasonography (POCUS) may be a valuable alternative screening tool in these instances.

Main research question:

To identify whether POCUS measurement of the rectus femoris muscle cross-sectional area (Qcsa) can be used as an alternative screening tool to predict functional decline, ED revisit or death in elderly patients in the ED.

Design (including population, confounders/outcomes):

This is a single centre prospective trial. Patients \>70 years and older presenting in the ED of the University Medical Centre Groningen (UMCG) who are participating in the Acutelines bio-databank are eligible for inclusion. 68 patients will be included. Data will be extracted from the Acutelines bio-databank. A trained physician will perform ultrasound measurements in a standardized way.

Expected results:

The aim of this study is to evaluate whether ultrasound measurements of the Qcsa can be utilized to identify older patients who are at risk for functional decline, ED revisit or death.

Study Timeline

• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-05-06
• Study Start: 2022-05-10
• Study First Posted: 2022-05-11
• Primary Completion: 2023-02-18
• Study Completion: 2023-05-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Age (>70 years)
• Presenting to the ED of the UMCG for one of the following specialties: internal medicine, nephrology, geriatric medicine, oncology, hematology, lung medicine, gastrointestinal/liver medicine, or emergency medicine (non-trauma).
• Consent obtained for participation in the Acutelines bio-databank

Exclusion Criteria

• Unable to obtain ultrasound image of rectus femoris (e.g. amputation, edema)
• Paresis or paralysis of one or both legs

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ultrasound Qcsa	1 day of admission to ED	POCUS Qcsa in older patients in the ED.
Mortality	3 months	Is there a relation between the performed POCUS Qcsa measurement at ED visit and mortality in older patients.
ED revisit	3 months	Is there a relation between the performed POCUS Qcsa measurement at ED visit and ED revisit in older patients.

Secondary Outcome Measures

Name	Time	Method
ED revisit: Ultrasound Qcsa versus Karnofsky Performance Score	3 months	To compare the ability of the Qcsa ultrasound versus the Karnofsky Performance Score (gold standard) to predict ED revisit in older patients in the ED.
Mortality: Ultrasound Qcsa versus Karnofsky Performance Score	3 months	To compare the ability of the Qcsa ultrasound versus the Karnofsky Performance Score (gold standard) to predict mortality in older patients in the ED.
ED revisit: Ultrasound Qcsa plus Karnofsky Performance Score	3 months	To compare the added value of Qcsa ultrasound versus the Karnofsky Performance Score (gold standard) to predict ED revisit in older patients in the ED.
Mortality: Ultrasound Qcsa plus Karnofsky Performance Score	3 months	To compare the added value of Qcsa ultrasound versus the Karnofsky Performance Score (gold standard) to predict mortality in older patients in the ED.

Trial Locations

Locations (1)

UMCG; 🇳🇱 Groningen, Netherlands