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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome; Pulmonary Edema
• Intervention / Treatment: Device: Strategy with lung ultrasound

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Midi Pyrenees
    • Toulouse, Midi Pyrenees, France, 31059
      • University Hospital Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 hours
The duration of the medical care.	The time between the patient support and the final diagnosis.	2 hours

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Thibault Le Gourrierec, MD, University Hospital, Toulouse

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2015
• Primary Completion (Actual): March 21, 2019
• Study Completion (Actual): March 21, 2019

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: December 17, 2015
• First Posted (Estimate): December 23, 2015

Study Record Updates

• Last Update Posted (Actual): June 7, 2019
• Last Update Submitted That Met QC Criteria: June 5, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: lung ultrasound; Respiratory Distress Syndrome; Pulmonary Edema
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Edema; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Pulmonary Edema
• Other Study ID Numbers: RC31/14/7423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO