Adverse Event Prediction in Geriatric Patients in the ED With Ultrasound

Frailty Clinical Trial

— AGEDU  

Official title:

Adverse Event Prediction in Geriatric Patients in the ED With Ultrasound

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05369962
• Other study ID #: 202100945
• Status: Recruiting
• Start date: May 10, 2022
• Est. completion date: September 2023

Study information

• Verified date: September 2023
• Source: University Medical Center Groningen
• Contact: Svenja Haak
• Phone: 0646771836
• Email: s.l.haak[@]umcg.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adverse Event
• Frailty

Intervention

Device:
• Ultrasound
Ultrasound measurements of the Qcsa

Locations

Country	Name	City	State
Netherlands	UMCG	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound Qcsa	POCUS Qcsa in older patients in the ED.	1 day of admission to ED
Primary	ED revisit	Is there a relation between the performed POCUS Qcsa measurement at ED visit and ED revisit in older patients.	3 months
Primary	Mortality	Is there a relation between the performed POCUS Qcsa measurement at ED visit and mortality in older patients.	3 months
Secondary	ED revisit: Ultrasound Qcsa versus Karnofsky Performance Score	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.	3 months
Secondary	Mortality: Ultrasound Qcsa versus Karnofsky Performance Score	To compare the ability of the Qcsa ultrasound versus the Karnofsky Performance Score (gold standard) to predict mortality in older patients in the ED.	3 months
Secondary	ED revisit: Ultrasound Qcsa plus Karnofsky Performance Score	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.	3 months
Secondary	Mortality: Ultrasound Qcsa plus Karnofsky Performance Score	To compare the added value of Qcsa ultrasound versus the Karnofsky Performance Score (gold standard) to predict mortality in older patients in the ED.	3 months