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

Respiratory Distress Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02638350
• Other study ID #: RC31/14/7423
• Status: Completed
• Phase: N/A
• Start date: December 7, 2015
• Est. completion date: March 21, 2019

Study information

• Verified date: June 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: March 21, 2019
• Est. primary completion date: March 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Pulmonary Edema
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse	Midi Pyrenees

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (5)

McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Böhm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Køber L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Rønnevik 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. Erratum in: Eur Heart J. 2013 Jan;34(2):158. — View 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. Epub 2006 Mar 24. — View 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. — View 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. Epub 2006 May 24. — View Citation

Zannad F, Mebazaa A, Juillière Y, Cohen-Solal A, Guize L, Alla F, Rougé 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. Epub 2006 Mar 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The duration of the medical care.	The time between the patient support and the final diagnosis.	2 hours