NCT04029051

Brief Summary

Brief Summary: The aim of this study is to analyze in elderly patients with undifferentiated dyspnea, the concordance of diagnosis before and after a focus thoracic ultrasound in comparison with the reference one established by an adjudication committee

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

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

Study Start

First participant enrolled

January 1, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

3.4 years

First QC Date

July 19, 2019

Last Update Submit

July 19, 2019

Conditions

Dyspnea

Outcome Measures

Primary Outcomes (1)

  • main objective

    Concordance between initial diagnosis after standard care, after thoracic ultrasound in comparison with the reference stated by the adjudication committee

    3 years

Secondary Outcomes (2)

  • Frequency

    3 years

  • mortality

    3 years

Interventions

Focus thoracic ultrasound for dyspnea diagnosisOTHER

Focus thoracic ultrasound is composed by an advanced cardiac ultrasound with Doppler measures and a lung ultrasound.

Eligibility Criteria

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

Elderly patient consulting in the emergency department for acute onset dyspnea

You may qualify if:

  • Acute onset dyspnea in patient over 74 years old consulting at the emergency department

You may not qualify if:

  • Need for ICU
  • Need for a mechanical ventilation
  • Less than 24 hours hospital stay
  • Inability to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

Related Publications (1)

  • De Carvalho H, Javaudin F, Le Bastard Q, Boureau AS, Montassier E, Le Conte P. Effect of chest ultrasound on diagnostic workup in elderly patients with acute respiratory failure in the emergency department: a prospective study. Eur J Emerg Med. 2021 Jan 1;28(1):29-33. doi: 10.1097/MEJ.0000000000000732.

    PMID: 32568788DERIVED

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

July 19, 2019

First Posted

July 23, 2019

Study Start

January 1, 2016

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

July 23, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)