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The goal of this Prospective interventional multicenter diagnostic study is to investigate the use of diaphragmatic ultrasound (DE) as a diagnostic tool in an adult emergency department for patients in acute respiratory distress.
The main question it aims to answer is to evaluate the relevance of measuring the Sum of Plateau Times (SPT) by Clinical Ultrasound in Emergency Medicine (CHEM) for the diagnosis of pneumopathy during acute respiratory distress (ARD) in the Emergency Department.
Secondary objectives include the study of other diaphragmatic ultrasound parameters, inspiratory plateau time (IPT) and expiratory plateau time (EPT), and the diagnostic relevance of PTS for the diagnosis of decompensation of Chronic obstructive pulmonary disease (BPCO) and acute cardiogenic pulmonary edema (APO).
Each eligible patient will have a right diaphragmatic ultrasound performed by a trained physician, then clinicobiological data will be collected later from medical records, and the etiological diagnosis will be established by a committee of 2 experts in the management of respiratory distress.
Diaphragmatic ultrasound (DE) has never been studied as a diagnostic tool in the emergency department. The sensitivity and specificity of pleural ultrasound for the diagnosis of pneumopathy is superior to that of chest radiography, with evidence of interstitial syndrome or unilateral pleural effusion, but it is not specific for infectious pneumopathy. Proving that diaphragmatic ultrasonography can be used to diagnose pneumopathy in respiratory distress, thanks to a specific index known as the Sum of Plateau Times (STP), will save time in patient management.
The secondary criteria of this study could be used in future studies, if they prove relevant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult emergency patients with acute respiratory distress | Experimental | Subjects aged ≥ 18 years presenting to the emergency department with ARD defined by respiratory rate (RR) > 25 and/or signs of struggle. Every potentially eligible patient will have a right diaphragmatic ultrasound performed by a doctor trained in the technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diaphragmatic ultrasound | Diagnostic Test | The examination is performed with a phased array probe, also known as a cardiac probe. The technique used will be that described and validated in anterior studies: the patient is in the Fowler position: half-seated, at an angle of around 45 degrees. The patient is ventilating spontaneously, and no participation is required. The probe is positioned in the sub-costal region between the mid-clavicular and anterior axillary line on the right, and between the anterior and middle axillary line in the sub- or intercostal region on the left. The liver is used as an acoustic window for the right hemi-diaphragm. The probe is oriented medially, cranially and dorsally. The operator switches to time-motion (TM) mode when an angle of over 70° is achieved between the upper part of the diaphragm and the analysis axis in the most cephalic part of the diaphragm. The image is frozen when 6 respiratory cycles have been measured. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the relevance of Sum of plateau times (STP) measurement by diaphragmatic ultrasound for the diagnosis of pneumopathy during acute respiratory distress (ARD) in an emergency department. (Specificity) | STP (in seconds) is a sum of inspiratory plateau time (IPT) and expiratory plateau time (TPE) measured in seconds. TPE is defined as the time between the end of diaphragmatic descent and the start of its ascent, measured by recording Diaphragmatic curves (DC). TPI is defined as the time between the end of diaphragmatic ascent and the start of its descent. These measurements will be carried out after the ultrasound on the diaphragmatic movements recorded. The diagnosis will be established on the basis of medical records by two independent experts. intrinsic diagnostic performance will be analyzed by specificity in percentage. specificity corresponds to the probability of STP of giving a negative diagnosis of pneumopathy among participants without pneumopathy according to expert review of medical records (gold standard) | Baseline |
| Assess the relevance of Sum of plateau times (STP) measurement by diaphragmatic ultrasound for the diagnosis of pneumopathy during acute respiratory distress (ARD) in an emergency department. (sensibility) | STP (in seconds) is a sum of inspiratory plateau time (IPT) and expiratory plateau time (TPE) measured in seconds. TPE is defined as the time between the end of diaphragmatic descent and the start of its ascent, measured by recording Diaphragmatic curves (DC). TPI is defined as the time between the end of diaphragmatic ascent and the start of its descent. These measurements will be carried out after the ultrasound on the diaphragmatic movements recorded. The diagnosis will be established on the basis of medical records by two independent experts. intrinsic diagnostic performance will be analyzed by sensibility in percentage. sensitivity corresponds to the probability of STP of giving a positive diagnosis of pneumopathy among participants with pneumopathy based on expert review of medical records (gold standard). | Baseline |
| Assess the relevance of Sum of plateau times (STP) measurement by diaphragmatic ultrasound for the diagnosis of pneumopathy during acute respiratory distress (ARD) in an emergency department. (Positive predictive values) |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (Sensibility) | Sensibility % | Baseline |
| Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (Specificity) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DINO TIKVESA, MD | Contact | 0467337974 | +33 | d-tikvesa@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| DINO TIKVESA, MD | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Nîmes | Not yet recruiting | Nîmes | Gard | 30900 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28552256 | Background | Jouneau S, Dres M, Guerder A, Bele N, Bellocq A, Bernady A, Berne G, Bourdin A, Brinchault G, Burgel PR, Carlier N, Chabot F, Chavaillon JM, Cittee J, Claessens YE, Delclaux B, Deslee G, Ferre A, Gacouin A, Girault C, Ghasarossian C, Gouilly P, Gut-Gobert C, Gonzalez-Bermejo J, Jebrak G, Le Guillou F, Leveiller G, Lorenzo A, Mal H, Molinari N, Morel H, Morel V, Noel F, Pegliasco H, Perotin JM, Piquet J, Pontier S, Rabbat A, Revest M, Reychler G, Stelianides S, Surpas P, Tattevin P, Roche N. Management of acute exacerbations of chronic obstructive pulmonary disease (COPD). Guidelines from the Societe de pneumologie de langue francaise (summary). Rev Mal Respir. 2017 Apr;34(4):282-322. doi: 10.1016/j.rmr.2017.03.034. Epub 2017 May 25. | |
| 22611136 |
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Prospective interventional multicenter diagnostic study
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The reference will be the etiological diagnosis based on expert opinion. Two experts (physicians experienced in the management of ARD) will judge, blind to each other and to the judgement criteria, the cause of the ARD on the basis of a medical file review at least one month after the ARD episode.
Ultrasound measurements will be analyzed a posteriori by an investigator blind to the results of the gold standard.
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|
STP is a sum of inspiratory plateau time (IPT) and expiratory plateau time (TPE) measured in seconds.
TPE is defined as the time between the end of diaphragmatic descent and the start of its ascent, measured by recording Diaphragmatic curves (DC).
TPI is defined as the time between the end of diaphragmatic ascent and the start of its descent.
These measurements will be carried out after the ultrasound on the diaphragmatic movements recorded.
The diagnosis will be established on the basis of medical records by two independent experts.
Extrinsic diagnostic performance will be analyzed by Positive predictive values (PPV) in percentage.
PPV corresponds to the probability of having pneumopathy if the PTS detects pneumopathy among participants with pneumopathy according to expert review of medical records (gold standard).
| Baseline |
| Assess the relevance of Sum of plateau times (STP) measurement by diaphragmatic ultrasound for the diagnosis of pneumopathy during acute respiratory distress (ARD) in an emergency department. (Negative predictive values) | STP is a sum of inspiratory plateau time (IPT) and expiratory plateau time (TPE) measured in seconds. TPE is defined as the time between the end of diaphragmatic descent and the start of its ascent, measured by recording Diaphragmatic curves (DC). TPI is defined as the time between the end of diaphragmatic ascent and the start of its descent. These measurements will be carried out after the ultrasound on the diaphragmatic movements recorded. Extrinsic diagnostic performance will be analyzed by Negative predictive values (NPV) in percentage. NPV corresponds to the probability of not having pneumopathy if the PTS does not detect pneumopathy among participants without pneumopathy according to the expert review of medical records (gold standard). | Baseline |
| Assess the relevance of Sum of plateau times (STP) measurement by diaphragmatic ultrasound for the diagnosis of pneumopathy during acute respiratory distress (ARD) in an emergency department. (Positive likelihood ratio) | STP is a sum of inspiratory plateau time (IPT) and expiratory plateau time (TPE) measured in seconds. TPE is defined as the time between the end of diaphragmatic descent and the start of its ascent, measured by recording Diaphragmatic curves (DC). TPI is defined as the time between the end of diaphragmatic ascent and the start of its descent. These measurements will be carried out after the ultrasound on the diaphragmatic movements recorded. The diagnosis will be established on the basis of medical records by two independent experts. Extrinsic diagnostic performance will be analyzed by Positive likelihood ratio (PLR) in percentage. it is the ratio of true positives to false positives | Baseline |
| Assess the relevance of Sum of plateau times (STP) measurement by diaphragmatic ultrasound for the diagnosis of pneumopathy during acute respiratory distress (ARD) in an emergency department. (Negative likelihood ratio) | STP is a sum of inspiratory plateau time (IPT) and expiratory plateau time (TPE) measured in seconds. TPE is defined as the time between the end of diaphragmatic descent and the start of its ascent, measured by recording Diaphragmatic curves (DC). TPI is defined as the time between the end of diaphragmatic ascent and the start of its descent. These measurements will be carried out after the ultrasound on the diaphragmatic movements recorded. Extrinsic diagnostic performance will be analyzed by Negative likelihood ratio (PLR) in percentage. It is the ratio of false negatives to true negatives | Baseline |
Specificity % |
| Baseline |
| Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (Positive predictive values (%)) | Positive predictive values (%) | Baseline |
| Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (Negative predictive values (%)) | Negative predictive values (%) | Baseline |
| Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (Positive likelihood ratio (%)) | Positive likelihood ratio (%) | Baseline |
| Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (Negative likelihood ratio (%)) | Negative likelihood ratio (%) | Baseline |
| Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department (Sensibility ) | Sensibility % | Baseline |
| Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency departmentSpecificity | Specificity % | Baseline |
| Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. Negative predictive values | Negative predictive values % | Baseline |
| Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. Positive likelihood ratio | Positive likelihood ratio % | Baseline |
| Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. Negative likelihood ratio | Negative likelihood ratio % | Baseline |
| Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Sensibility | Sensibility % | Baseline |
| Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Specificity | Specificity % | Baseline |
| Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive predictive values | Positive predictive values % | Baseline |
| Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative predictive values | Negative predictive values % | Baseline |
| Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive likelihood ratio | Positive likelihood ratio % | Baseline |
| Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative likelihood ratio | Negative likelihood ratio % | Baseline |
| Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Sensibility | Sensibility % | Baseline |
| Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Specificity | Specificity % | Baseline |
| Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive predictive values | Positive predictive values % | Baseline |
| Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative predictive values | Negative predictive values % | Baseline |
| Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive likelihood ratio | Positive likelihood ratio % | Baseline |
| Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative likelihood ratio | Negative likelihood ratio % | Baseline |
| Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Sensibility | Sensibility % | Baseline |
| Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Specificity | Specificity % | Baseline |
| Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive predictive values | Positive predictive values % | Baseline |
| Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative predictive values | Negative predictive values % | Baseline |
| Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive likelihood ratio | Positive likelihood ratio % | Baseline |
| Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative likelihood ratio | Negative likelihood ratio % | Baseline |
| Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Sensibility | Sensibility % | Baseline |
| Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Specificity | Specificity % | Baseline |
| Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive predictive values | Positive predictive values % | Baseline |
| Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative predictive values | Negative predictive values % | Baseline |
| Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive likelihood ratio | Positive likelihood ratio % | Baseline |
| Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative likelihood ratio | Negative likelihood ratio % | Baseline |
| Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Sensibility | Sensibility % | Baseline |
| Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Specificity | Specificity % | Baseline |
| Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive predictive values | Positive predictive values % | Baseline |
| Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative predictive values | Negative predictive values % | Baseline |
| Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive likelihood ratio | Positive likelihood ratio % | Baseline |
| Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative likelihood ratio | Negative likelihood ratio % | Baseline |
| Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Sensibility | Sensibility % | Baseline |
| Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Specificity | Specificity % | Baseline |
| Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive predictive values | Positive predictive values % | Baseline |
| Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative predictive values | Negative predictive values % | Baseline |
| Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive likelihood ratio | Positive likelihood ratio % | Baseline |
| Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative likelihood ratio | Negative likelihood ratio % | Baseline |
| Visually analyze the shape of the Diaphragmatic curves (DC) of patients seen for ARD in the emergency department and whose cause is mixed (association of at least two causes). | Descriptive analysis of curve shapes | Baseline |
| Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. Positive predictive values | Positive predictive values % | Baseline |
| University Hospital of Montpellier | Recruiting | Montpellier | Hérault | 34295 | France |
|
| 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. |
| Background | Abdallah S, Pihan F, Vandroux D. Échographie diaphragmatique : applications au-delà du sevrage de la ventilation. Le Praticien en Anesthésie Réanimation. 1 sept 2023;27(4):205-11. |
| Background | Jung B, Guillon A, pour la Commission de la recherche translationnelle de la SRLF. Échographie du diaphragme en réanimation. Schnell D, Charles PE, éditeurs. Méd Intensive Réa. janv 2019;28(1):60-3 |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012128 | Respiratory Distress Syndrome |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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