Evaluation of the Relevance of Diaphragmatic Stroke Ultrasound for the Etiological Diagnosis of Acute Respiratory Distress in an Emergency Department.

Official title

Evaluation of the Relevance of Diaphragmatic Stroke Ultrasound for the Etiological Diagnosis of Acute Respiratory Distress in an Emergency Department: a Prospective Multicenter Study.

Overview

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.

Detailed description

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.

Interventions

• Diagnostic test diaphragmatic ultrasound
  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

Primary outcome measures

• 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: Baseline]

Secondary outcome measures (12)

• Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (Sensibility) [Time frame: Baseline]
• Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (Specificity) [Time frame: 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 (%)) [Time frame: 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 (%)) [Time frame: 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 (%)) [Time frame: 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 (%)) [Time frame: Baseline]
• Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department (Sensibility ) [Time frame: Baseline]
• Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency departmentSpecificity [Time frame: Baseline]
• Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. Negative predictive values [Time frame: Baseline]
• Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. Positive likelihood ratio [Time frame: Baseline]
• Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. Negative likelihood ratio [Time frame: Baseline]
• Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Sensibility [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

• Patients 18 years of age or older;
• Patient with ARD defined by respiratory rate (RR) strictly superior to 25 and/or signs of struggle which are: thoraco-abdominal rocking, active abdominal breathing, recruitment of extra-diaphragmatic respiratory muscles AND
• peripheral saturation (SpO2) strictly inferior to 90% and/or hypercapnic acidosis (pH strictly inferior to 7.35 and pCO2 strictly superior to 45mmHg) on arterial blood gases;
• Spontaneous ventilation.
• Patients presenting a clinical severity score of Grade 1 with signs of struggle, as well as those with Grade 2 and Grade 3. A clinical severity score will be used as follows: Grade 1: Minimal polypnoea with respiratory rate (RR) between 20 and 25 ; Grade 2: Moderate polypnoea with respiratory rate (RR) between 25 and 35; Grade 3: Major polypnoea with respiratory rate (RR) between 35 to 50.

Exclusion criteria

• Adult protected by law (guardianship, curatorship, legal protection)
• Refusal of consent after information
• Patient on non-invasive ventilation ;
• Patient on mechanical ventilation;
• Respiratory rate superior to 50/min
• Patient currently being treated for infectious pneumopathy with antibiotics;
• Pregnant or breast-feeding women;
• Patients with any known history of diaphragmatic pathologies.
• Illiterate or unable to understand the purpose and methodology of the study.
• Patient not affiliated to a social security scheme or not benefiting from such a scheme.
• Person deprived of liberty (by judicial or administrative decision, or forced hospitalization)
• Person participating in another study with an exclusion period still in progress,

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

France · 2 centers

• University Hospital of Nîmes — Nîmes
• University Hospital of Montpellier — Montpellier

Publications

• 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, Piq PMID 28552256
• 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 acu PMID 22611136
• 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.
• 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

Identifiers

NCT: NCT06650137 · RECHMPL23_0425

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗