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

NCT02638350 | Completed DMC

• 1 other identifier: RC31/14/7423
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Edema; Respiratory Distress Syndrome

Keywords

lung ultrasound; Pulmonary Edema; Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of the proportion of appropriate and inappropriate treatment.

  2 hours

• The duration of the medical care.

  2 hours

Study Arms (1)

Intervention lung ultrasound

EXPERIMENTAL

All patients will have strategy with lung ultrasoundlung ultrasound

Device: Strategy with lung ultrasound

Interventions

Strategy with lung ultrasound DEVICE

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.

Intervention lung ultrasound

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Vital signs of distress requiring intubation tracheal immediately
• Myocardial infarction lower seat with extension to the right ventricle, in the acute phase

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, Midi Pyrenees, 31059, France

Location

Related Publications (5)

• 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.

  PMID: 16516552 BACKGROUND

• 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.

  PMID: 16934640 BACKGROUND

• 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.

  PMID: 11887977 BACKGROUND

• 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.

  PMID: 16723034 BACKGROUND

• 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.

  PMID: 22611136 BACKGROUND

MeSH Terms

Conditions

Pulmonary Edema; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Thibault Le Gourrierec, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 23, 2015
• Study Start: December 7, 2015
• Primary Completion: March 21, 2019
• Study Completion: March 21, 2019
• Last Updated: June 7, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)