NCT06650137Recruiting
Evaluation of the Relevance of Diaphragmatic Stroke Ultrasound for the Etiological Diagnosis of Acute Respiratory Distress in an Emergency Department.
Evaluation of the Relevance of Diaphragmatic Stroke Ultrasound for the Etiological Diagnosis of Acute Respiratory Distress in an Emergency Department: a Prospective Multicenter Study.
Source: ClinicalTrials.gov · Last updated 6 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 4 Oct 2024
- Start date
- 27 Nov 2024
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- University Hospital, Montpellier
- Diseases
- Stroke
- NCT number
- NCT06650137
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 27 Nov 2024 to the primary completion date, 1 Nov 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with any known history of diaphragmatic pathologies.
Other
- 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;
- 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,
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| University Hospital of Nimes Coordinator of this site? Confirm its status | Nîmes | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.