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

NCT ID: NCT06650137

Last Updated: 2024-12-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-27
• Study Completion Date: 2026-11-01

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.

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Adult emergency patients with acute respiratory distress

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.

Group Type: EXPERIMENTAL

diaphragmatic ultrasound

Intervention Type: 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.

Interventions

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 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.

Intervention Type: DIAGNOSTIC_TEST

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,

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

DINO TIKVESA, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

University Hospital of Nîmes

Nîmes, Gard, France

Site Status: NOT_YET_RECRUITING

University Hospital of Montpellier

Montpellier, Hérault, France

Site Status: RECRUITING

Countries

France

Central Contacts

DINO TIKVESA, MD

Role: CONTACT

Phone: 0467337974

Email: d-tikvesa@chu-montpellier.fr

Facility Contacts

Fabien COISY, MD

Role: primary

Dino TIKVESA, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 28552256 (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)

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.

Reference Type: 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

Reference Type: BACKGROUND

Other Identifiers

RECHMPL23_0425

Identifier Type: -

Identifier Source: org_study_id