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Performance Evaluation of Clinical Ultrasound in Management of Acute Pulmonary Edema in Elderly Patient (ECHOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02638350
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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Brief Summary:
The main objective is to assess the validation of the diagnosis early acute pulmonary edema in elderly patients with acute respiratory distress, admitted in a host of vital emergency services by lung ultrasound associated with the measurement of the inferior vena cava.

Condition or disease Intervention/treatment Phase
Pulmonary Edema Respiratory Distress Syndrome Device: Strategy with lung ultrasound Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Performance Evaluation of Clinical Ultrasound in Management of Acute Pulmonary Edema in Elderly Patient Over 65 Years, Admitted to a Host of Vital Emergency Services
Actual Study Start Date : December 7, 2015
Actual Primary Completion Date : March 21, 2019
Actual Study Completion Date : March 21, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema Ultrasound

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention lung ultrasound
All patients will have strategy with lung ultrasoundlung ultrasound
 Device: Strategy with lung ultrasound

Each patient admitted for suspicion of acute lung edema will be treated according to the protocol of the emergency department.

Another doctor will independently do a lung ultrasound and measurement of the inferior vena cava. The ultrasound results are not made available to the doctor in charge of the patient.

At the end of the study, all the files will be analyzed by a independent committee, blinded ultrasound results for the final diagnosis of acute pulmonary edema.


Outcome Measures
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Primary Outcome Measures :
  1. The result of lung ultrasound associated with the measurement of the inferior vena cava. [ Time Frame: 2 hours ]

    Confirm the diagnosis of acute pulmonary edema associated with lung ultrasound to measure the inferior vena cava in patients aged over 65 years in acute respiratory distress, admitted to a service life-threatening emergencies.

    By checking the results of the ultrasound done by a different doctor from the one who took care of the patient.



Secondary Outcome Measures :
  1. Number of the proportion of appropriate and inappropriate treatment. [ Time Frame: 2 hours ]
    Comparison of specific treatments begun to emergency, as defined by the latest recommendations of Cardiology and Pneumology companies compared to the treatment that would have been given over the results of pulmonary ultrasound.

  2. The duration of the medical care. [ Time Frame: 2 hours ]
    The time between the patient support and the final diagnosis.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with compatible episode with acute edema (tachypnea with respiratory rate> 25/min and/or oxygen saturation on room air <90%, auscultation, dyspnea, sudden onset of symptoms)

Exclusion Criteria:

  • Vital signs of distress requiring intubation tracheal immediately
  • Myocardial infarction lower seat with extension to the right ventricle, in the acute phase
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638350


Locations
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France
University Hospital Toulouse
Toulouse, Midi Pyrenees, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Thibault Le Gourrierec, MD University Hospital, Toulouse
More Information
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Publications:

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02638350    
Other Study ID Numbers: RC31/14/7423
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Toulouse:
lung ultrasound
Pulmonary Edema
Respiratory Distress Syndrome
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Pulmonary Edema
Edema
Lung Diseases
 Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases