NCT05126940

Brief Summary

This study assesses the potential of lung ultrasonography to diagnose heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

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, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

1.1 years

First QC Date

September 29, 2021

Last Update Submit

November 8, 2021

Conditions

Keywords

Lung ultrasoundheart failurediagnosisaccuracynurses

Outcome Measures

Primary Outcomes (4)

  • the accuracy of LUS performed by nurses in the diagnosis of heart failure

    the accuracy of LUS in the diagnosis of heart failure measured by sensitivity .

    0 days

  • the Specificity of LUS by nurses in the diagnosis of heart failure

    the accuracy of LUS in the diagnosis of heart failure measured by specificity.

    0 days

  • the reproducibility of LUS in by nurses the diagnosis of heart failure

    the accuracy of LUS in the diagnosis of heart failure measured by area under the roc curve

    0 days

  • Agreement between nurses and expert's

    Agreement between nurses and expert's interpretation was assessed by kappa agreement index for ordinal LUS scale classification

    0 days

Study Arms (2)

nurses

ED nurses trained to perform LUS and blinded to the final diagnosis

Diagnostic Test: we perform a lung ultrasound to all the patients admitted for dyspnea independantly from the final diagnosis

emergency physician

certified emergency physician who had accomplished a full mentoring program for "Ultra-Sound Life Support".

Diagnostic Test: we perform a lung ultrasound to all the patients admitted for dyspnea independantly from the final diagnosis

Interventions

Patients were placed in a semi-recumbent or supine position depending on their respiratory tolerance. For each side of the chest, 4 zones have to be assessed : 2 anterior and 2 lateral. The operator should calculate the number of B-lines when present .

Also known as: lus
emergency physiciannurses

Eligibility Criteria

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

A convenience sampling approach, including all patients admitted to the ED for acute dyspnea as chief complaint, was used.

You may qualify if:

  • non traumatic dyspnea with the final diagnosis of heart failure

You may not qualify if:

  • age less than 18 years
  • impossibility to give consent to participate in the study
  • post-traumatic dyspnea
  • pregnant women
  • need for endotracheal intubation or inotropic drugs
  • patients who were deemed too unstable for sonography by the treating team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nouira Semir

Monastir, 5000, Tunisia

Location

MeSH Terms

Conditions

DyspneaHeart FailureDisease

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesPathologic Processes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 29, 2021

First Posted

November 19, 2021

Study Start

January 1, 2018

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

November 19, 2021

Record last verified: 2021-11

Locations