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

NCT ID: NCT02638350

Last Updated: 2019-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-07

Study Completion Date

2019-03-21

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Edema Respiratory Distress Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intervention lung ultrasound

All patients will have strategy with lung ultrasoundlung ultrasound

Group Type EXPERIMENTAL

Strategy with lung ultrasound

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thibault Le Gourrierec, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital Toulouse

Toulouse, Midi Pyrenees, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 16516552 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16934640 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11887977 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16723034 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22611136 (View on PubMed)

Other Identifiers

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RC31/14/7423

Identifier Type: -

Identifier Source: org_study_id

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