Clinical trial NCT05369962: Adverse Event Prediction in Geriatric Patients in the ED With Ultrasound
Official title: Adverse Event Prediction in Geriatric Patients in the ED With Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Adverse Event
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 68
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \>70 years and older presenting in the ED of the UMCG hospital who are participating in the Acutelines bio-databank are eligible for inclusion.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ultrasound Qcsa
timeFrame: 1 day of admission to ED
measure: ED revisit
timeFrame: 3 months
measure: Mortality
timeFrame: 3 months
Secondary outcomes:
measure: ED revisit: Ultrasound Qcsa versus Karnofsky Performance Score
timeFrame: 3 months
measure: Mortality: Ultrasound Qcsa versus Karnofsky Performance Score
timeFrame: 3 months
measure: ED revisit: Ultrasound Qcsa plus Karnofsky Performance Score
timeFrame: 3 months
measure: Mortality: Ultrasound Qcsa plus Karnofsky Performance Score
timeFrame: 3 months
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: UMCG
Study officials:
affiliation: UMCG
name: Svenja Haak
role: PRINCIPAL_INVESTIGATOR
References: