NCT05369962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 10, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2023

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

March 21, 2022

Last Update Submit

March 24, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Ultrasound Qcsa

    POCUS Qcsa in older patients in the ED.

    1 day of admission to ED

  • ED revisit

    Is there a relation between the performed POCUS Qcsa measurement at ED visit and ED revisit in older patients.

    3 months

  • Mortality

    Is there a relation between the performed POCUS Qcsa measurement at ED visit and mortality in older patients.

    3 months

Secondary Outcomes (4)

  • ED revisit: Ultrasound Qcsa versus Karnofsky Performance Score

    3 months

  • Mortality: Ultrasound Qcsa versus Karnofsky Performance Score

    3 months

  • ED revisit: Ultrasound Qcsa plus Karnofsky Performance Score

    3 months

  • Mortality: Ultrasound Qcsa plus Karnofsky Performance Score

    3 months

Interventions

Ultrasound measurements of the Qcsa

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMCG

Groningen, Netherlands

Location

MeSH Terms

Conditions

Frailty

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Svenja Haak

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 21, 2022

First Posted

May 11, 2022

Study Start

May 10, 2022

Primary Completion

February 18, 2023

Study Completion

May 20, 2023

Last Updated

March 27, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations