NCT06491290

Brief Summary

The goal of this observational study is to evaluate the impact of primary air pollutants and weather parameters on emergency department (ED) visits in the metropolitan area of Florence.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
480,000

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress59%
Jan 2024Dec 2027

Study Start

First participant enrolled

January 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

3 years

First QC Date

June 21, 2024

Last Update Submit

July 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • number of daily emergency department visits

    Total number of emergency department visits on a given day

    through study completion, 1 year

Other Outcomes (4)

  • number of patients with Levels of Urgency (I-V) of emergency department visits

    through study completion, 1 year

  • Number of patients with the most frequent primary complaints of emergency department visits

    through study completion, 1 year

  • Number of patients hospitalised

    through study completion, 1 year

  • +1 more other outcomes

Study Arms (1)

Study cohort

Other: No intervention administered

Interventions

NA (not applicable)

Study cohort

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of consecutive patients presenting to the Emergency Departments (ED) of the participating hospital.

You may qualify if:

  • Consecutive emergency department visits within the study period

You may not qualify if:

  • Patients resident outside the metropolitan area investigated
  • Patients admitted to the emergency department for traumatic injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SOD Medicina e Chirurgia d'Urgenza ed Accettazione, Azienda Ospedaliera-Universitaria Careggi

Florence, 50134, Italy

RECRUITING

Related Publications (1)

  • Gnerucci A, Rossetto A, Faraoni P, Ranaldi F, Cavallaro G, Tonietti B, Santosuosso U, Bonaccorsi L, Nazerian P; SIMEU Study Group. Particulate matter concentration is associated with increased utilization of the emergency department: a single-centre time-series analysis. Intern Emerg Med. 2025 Jun 19. doi: 10.1007/s11739-025-04013-2. Online ahead of print.

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Director Emergency Department

Study Record Dates

First Submitted

June 21, 2024

First Posted

July 9, 2024

Study Start

January 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

July 9, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations