Pulmonary EdemaECHOPNCT02638350
Performance Evaluation of Clinical Ultrasound in Management of Acute Pulmonary Edema in Elderly Patient
A study testing Strategy with lung ultrasound in people with Pulmonary Edema and Respiratory Distress Syndrome, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pulmonary Edema, Respiratory Distress Syndrome
- What is being tested?
- Strategy with lung ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteFrance
- Study dates
- 7 Dec 2015to 21 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- Vital signs of distress requiring intubation tracheal immediately
- Myocardial infarction lower seat with extension to the right ventricle, in the acute phase
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Strategy with lung ultrasound
- Keywords
- lung ultrasound, Pulmonary Edema, Respiratory Distress Syndrome
- Medical subject headings
- Pulmonary Edema, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strategy with lung ultrasoundDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention lung ultrasound | Experimental | All patients will have strategy with lung ultrasoundlung ultrasound Receives: Device: Strategy with lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Secondary outcomes (2)
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.
Measured: 2 hours
The duration of the medical care.
The time between the patient support and the final diagnosis.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study start7 Dec 2015
- Primary completion21 Mar 2019
- Study completion21 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EdemaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thibault Le Gourrierec, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638350
- Sponsor's protocol ID
- RC31/14/7423
- Acronym
- ECHOP
- Status last verified
- Jun 2019
- First submitted
- 15 Dec 2015
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 16516552Melniker 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.
PubMed 16934640Nielsen 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.
PubMed 11887977Ray 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.
PubMed 16723034McMurray 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.
PubMed 22611136
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02638350
- Acronym / sponsor ID
- ECHOP / RC31/14/7423
- Conditions
- Pulmonary Edema, Respiratory Distress Syndrome
- Keywords
- lung ultrasound, Pulmonary Edema, Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 7 Dec 2015 (actual)
- Primary completion
- 21 Mar 2019 (actual)
- Study completion
- 21 Mar 2019 (actual)
- First posted
- 23 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention lung ultrasound | Experimental | Device: Strategy with lung ultrasoundAll patients will have strategy with lung ultrasoundlung ultrasound |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (2 listed)
- Vital signs of distress requiring intubation tracheal immediately
- Myocardial infarction lower seat with extension to the right ventricle, in the acute phase
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strategy with lung ultrasoundEach 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. | Device | Intervention lung ultrasound |
Primary outcome
The result of lung ultrasound associated with the measurement of the inferior vena cava.
Time frame: 2 hours
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 secondary outcomes
Number of the proportion of appropriate and inappropriate treatment.
Time frame: 2 hours
The duration of the medical care.
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Background: PubMed 16516552Zannad 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.
- Background: PubMed 16934640Melniker 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.
- Background: PubMed 11887977Nielsen 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.
- Background: PubMed 16723034Ray 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.
- Background: PubMed 22611136McMurray 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thibault Le Gourrierec, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strategy with lung ultrasound in people with Pulmonary Edema and Respiratory Distress Syndrome, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The result of lung ultrasound associated with the measurement of the inferior vena cava. (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02638350, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.