NCT04929704

Brief Summary

The confusional syndrome is defined by the acute or subacute onset of a deficit syndrome (temporo-spatial disorientation, memory and concentration disorders, abnormal behavior, impairment of intellectual efficiency, fluctuation of disorders with an increase in the evening) that may be associated with a productive syndrome (visual or auditory hallucinations, delusional elements) (French College of Neurology). It is a frequent, serious and costly problem in hospitalized patients and in emergency rooms. Its prevalence is between 10 and 31% of cases in emergency rooms and concerns up to one out of two elderly patients during a hospitalization. The potential morbidity and mortality of the confusional syndrome is due in part to the difficulty of identifying and treating rapidly the triggering and aggravating factors that are often interrelated in the elderly. Most often, these are drug effects, metabolic disorders, infections, consequences of prolonged immobilization or physical restraint. The lack of rapid treatment of these causes increases the risk of medium and long-term cognitive problems. Because of the aging population, this is an increasingly expensive problem. In 2012, the World Health Organization Regional Office for Europe study conducted in 18 European countries combined estimated its cost at $182 billion per year. The management of confusional syndrome in the elderly is now a major public health issue. It is a targeted indicator of the safety and quality of care for the elderly.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
470

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

June 11, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2021

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

June 30, 2022

Status Verified

April 1, 2022

Enrollment Period

1 month

First QC Date

June 10, 2021

Last Update Submit

June 29, 2022

Conditions

Keywords

elderly patients

Outcome Measures

Primary Outcomes (1)

  • Determine the diagnostic yield of brain scans without contrast injection for patients aged ≥ 75 years with isolated confusional syndrome (proportion of scans explaining symptomatology)

    Evidence of a recent intracranial abnormality compatible with the patient's symptomatology (isolated confusional syndrome)

    Day 1

Secondary Outcomes (4)

  • To determine the impact of performing an injection-free brain scan to patients aged ≥ 75 years with isolated confusional syndrome on the duration of their emergency department management.

    Day 1

  • Identify the anamnestic, clinical, and biological variables available in the emergency department associated with the discovery of an intracranial process on CT explaining the clinical picture.

    Day 1

  • To determine the main etiology of the confusional syndrome in patients whose CT scan did not find an acute abnormality explaining the symptomatology.

    Day 1

  • Determine the impact of the CT scan result on the patient's initial medical management strategy (first 24 hours).

    Day 1

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient aged ⩾ 75 years who had a brain scan without contrast injection in the emergency department due to isolated confusional syndrome between January 1, 2019 and December 31, 2019.

You may qualify if:

  • Patient aged ⩾ 75 years who had a brain scan without contrast injection in the emergency department due to isolated confusional syndrome between January 1, 2019 and December 31, 2019.
  • French-speaking patient

You may not qualify if:

  • Patient with concomitant localizing neurological signs of confusional syndrome: abnormalities of the cranial pairs, unusual headaches, meningeal syndrome, cerebellar syndrome, systematized sensory or motor deficit, vestibular syndrome, Glasgow Coma Scale score ≤ 8.
  • Patient who has had a head injury and is taking a long-term antiplatelet and/or anticoagulant therapy.
  • Patient objecting to the use of their data for this research.
  • Patient deprived of liberty
  • Patient under court protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

  • Camille GERLIER, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2021

First Posted

June 18, 2021

Study Start

June 11, 2021

Primary Completion

July 11, 2021

Study Completion

May 31, 2023

Last Updated

June 30, 2022

Record last verified: 2022-04

Locations