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

NCT06650137 | Recruiting

• 1 other identifier: RECHMPL23_0425
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pneumonia; Diaphragm; Movement; Diaphragmatic Ultrasound; Emergency Medical Services; Acute Respiratory Distress Syndrome (ARDS)

Keywords

Diaphragmatic ultrasound,; ultrasonography; Pneumonia; Diaphragm; Acute respiratory failure; Emergency; Diaphragmatic excursion

Outcome Measures

Primary Outcomes (6)

• 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)

  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

Secondary Outcomes (49)

• Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (Sensibility)

  Baseline

• Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (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 (%))

  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 (%))

  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 (%))

  Baseline

Study Arms (1)

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.

Diagnostic Test: diaphragmatic ultrasound

Interventions

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.

Adult emergency patients with acute respiratory distress

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (2)

University Hospital of Nîmes

Nîmes, Gard, 30900, France

NOT YET RECRUITING

University Hospital of Montpellier

Montpellier, Hérault, 34295, France

RECRUITING

Related Publications (4)

• 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.

  PMID: 28552256 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

• 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

  BACKGROUND

MeSH Terms

Conditions

Pneumonia; Respiratory Distress Syndrome; Emergencies

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• DINO TIKVESA, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DINO TIKVESA, MD

CONTACT

0467337974; d-tikvesa@chu-montpellier.fr

Study Design

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

Model Details: Prospective interventional multicenter diagnostic study

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 21, 2024
• Study Start: November 27, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

FR (2)