NCT01818882

Brief Summary

The main objective of our study is to compare the effects of two care strategies for dyspneic patients on the length of hospital stay: (1) standard care (=contextual analysis + conventional clinical chest radiography) versus (2) standard care + pleuropulmonary ultrasound.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

March 23, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
1 year until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 6, 2016

Status Verified

March 1, 2016

Enrollment Period

1.8 years

First QC Date

March 23, 2013

Last Update Submit

April 5, 2016

Conditions

Dyspnea

Keywords

Vscanportable ultrasoundemergency careemergency room

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay in days

    1 month

Secondary Outcomes (49)

  • Patient deceased? yes/no

    1 month

  • Diagnosis in the emergency room

    upon discharge from the emergency department (max 1 month)

  • Diagnosis given by expert committee based on patient file

    1 month

  • Glasgow scale

    Baseline, day 0

  • Glasgow scale

    day 3

  • +44 more secondary outcomes

Study Arms (2)

Standard care

ACTIVE COMPARATOR

Patients randomized to this arm will receive standard care. Intervention: Standard care.

Other: Standard care

Standard care + ultrasound

EXPERIMENTAL

Patients randomized to this arm will receive standard care + pleuropulmonary ultrasound. Intervention: Standard care + ultrasound

Other: Standard careDevice: Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI)

Interventions

Standard careOTHER

Standard care for dyspneic patients including contextual analysis, conventional clinical exam and a chest X-Ray.

Standard careStandard care + ultrasound
Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI)DEVICE

Standard care (as described for the other intervention) + pleuropulmonary ultrasound using the Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI).

Standard care + ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • Patient consulting in the emergency department for dyspnea

You may not qualify if:

  • The patient is participating in another study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient cannot read French
  • The patient is pregnant, parturient, or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

DyspneaEmergencies

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Xavier Bobbia, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2013

First Posted

March 27, 2013

Study Start

April 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 6, 2016

Record last verified: 2016-03

Locations

FR(1)