Performance Evaluation of Clinical Ultrasound in Management of Acute Pulmonary Edema in Elderly Patient (ECHOP)
Primary Purpose
Pulmonary Edema, Respiratory Distress Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Strategy with lung ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Edema focused on measuring lung ultrasound, Pulmonary Edema, Respiratory Distress Syndrome
Eligibility 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
Sites / Locations
- University Hospital Toulouse
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention lung ultrasound
Arm Description
All patients will have strategy with lung ultrasoundlung ultrasound
Outcomes
Primary Outcome Measures
The result of lung ultrasound associated with the measurement of the inferior vena cava.
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
Number of the proportion of appropriate and inappropriate treatment.
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.
The duration of the medical care.
The time between the patient support and the final diagnosis.
Full Information
NCT ID
NCT02638350
First Posted
December 15, 2015
Last Updated
June 5, 2019
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT02638350
Brief Title
Performance Evaluation of Clinical Ultrasound in Management of Acute Pulmonary Edema in Elderly Patient
Acronym
ECHOP
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
December 7, 2015 (Actual)
Primary Completion Date
March 21, 2019 (Actual)
Study Completion Date
March 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Edema, Respiratory Distress Syndrome
Keywords
lung ultrasound, Pulmonary Edema, Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention lung ultrasound
Arm Type
Experimental
Arm Description
All patients will have strategy with lung ultrasoundlung ultrasound
Intervention Type
Device
Intervention Name(s)
Strategy with lung ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
The result of lung ultrasound associated with the measurement of the inferior vena cava.
Description
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.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Number of the proportion of appropriate and inappropriate treatment.
Description
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.
Time Frame
2 hours
Title
The duration of the medical care.
Description
The time between the patient support and the final diagnosis.
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thibault Le Gourrierec, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
State/Province
Midi Pyrenees
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16516552
Citation
Zannad F, Mebazaa A, Juilliere Y, Cohen-Solal A, Guize L, Alla F, Rouge P, Blin P, Barlet MH, Paolozzi L, Vincent C, Desnos M, Samii K; EFICA Investigators. Clinical profile, contemporary management and one-year mortality in patients with severe acute heart failure syndromes: The EFICA study. Eur J Heart Fail. 2006 Nov;8(7):697-705. doi: 10.1016/j.ejheart.2006.01.001. Epub 2006 Mar 3.
Results Reference
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PubMed Identifier
16934640
Citation
Melniker LA, Leibner E, McKenney MG, Lopez P, Briggs WM, Mancuso CA. Randomized controlled clinical trial of point-of-care, limited ultrasonography for trauma in the emergency department: the first sonography outcomes assessment program trial. Ann Emerg Med. 2006 Sep;48(3):227-35. doi: 10.1016/j.annemergmed.2006.01.008. Epub 2006 Mar 24.
Results Reference
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PubMed Identifier
11887977
Citation
Nielsen LS, Svanegaard J, Wiggers P, Egeblad H. The yield of a diagnostic hospital dyspnoea clinic for the primary health care section. J Intern Med. 2001 Nov;250(5):422-8. doi: 10.1046/j.1365-2796.2001.00901.x.
Results Reference
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PubMed Identifier
16723034
Citation
Ray P, Birolleau S, Lefort Y, Becquemin MH, Beigelman C, Isnard R, Teixeira A, Arthaud M, Riou B, Boddaert J. Acute respiratory failure in the elderly: etiology, emergency diagnosis and prognosis. Crit Care. 2006;10(3):R82. doi: 10.1186/cc4926. Epub 2006 May 24.
Results Reference
background
PubMed Identifier
22611136
Citation
McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. No abstract available. Erratum In: Eur Heart J. 2013 Jan;34(2):158.
Results Reference
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Performance Evaluation of Clinical Ultrasound in Management of Acute Pulmonary Edema in Elderly Patient
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