NCT02967809

Brief Summary

Estimate if the use of a portable cardiac echograph for intra-hospital Emergencie improves the performances diagnose in the bed of patient in department of conventional medicine. The concordance between the initial medical diagnosis (previous the utilsation of portable echograph) and the final diagnosis (after portable echograph utisation) will be evaluated. These evaluation will be performed after retrospective review of the medical files

Trial Health

87
On Track

Trial Health Score

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

Enrollment
172

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

April 27, 2020

Status Verified

April 1, 2020

Enrollment Period

2.1 years

First QC Date

November 14, 2016

Last Update Submit

April 22, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Concordance between initial medecial diagnosis and final diagnosis

    Concordance between the initial medical diagnosis at the bedside in ward and the definitive diagnosis after retrospective review of the medical files between two groups : one with an ultraportative echograph (POCUS group) and a control (without ultraportative group). The percentage of adequate initiale diagnosis at the bedside.

    1 day

Study Arms (2)

final diagnosis after portable echography

Experimental group: final diagnosis after portable cardiac echograph examination

Device: echography

final diagnosis without portable echography

Group control: Final diagnosis for patient ( same medical condition and history) hospitalized in units without portable cardiac echograph examination avaible

Interventions

cardiac and pulmonary echography

final diagnosis after portable echography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient suffering of respiratory or cardiac distress

You may qualify if:

  • respiratory or cardiac distress

You may not qualify if:

  • pulmonary or cardiac patient transplant morphologic abnormalities Patient in rescucitation care unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement anesthesie reanimation hopital nord

Marseille, 13015, France

Location

Related Publications (1)

  • Zieleskiewicz L, Lopez A, Hraiech S, Baumstarck K, Pastene B, Di Bisceglie M, Coiffard B, Duclos G, Boussuges A, Bobbia X, Einav S, Papazian L, Leone M. Bedside POCUS during ward emergencies is associated with improved diagnosis and outcome: an observational, prospective, controlled study. Crit Care. 2021 Jan 22;25(1):34. doi: 10.1186/s13054-021-03466-z.

MeSH Terms

Conditions

Respiratory InsufficiencyHeart Failure

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Marc Leone, MD

    DAR Nord

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2016

First Posted

November 18, 2016

Study Start

October 1, 2016

Primary Completion

November 1, 2018

Study Completion

September 1, 2019

Last Updated

April 27, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations