Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Not applicable

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

NCT06650137 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-11-27
Last updated
2024-12-06

Condition(s) studied

PneumoniaDiaphragm; MovementDiaphragmatic UltrasoundEmergency Medical ServicesAcute Respiratory Distress Syndrome (ARDS)

Investigational drug(s) / intervention(s)

diaphragmatic ultrasound

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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,

Primary outcome measure(s)

  • 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) — Baseline
    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)
  • 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) — Baseline
    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).
  • 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) — Baseline
    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).
  • 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) — Baseline
    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).
  • 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) — Baseline
    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
  • 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) — Baseline
    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

Trial sites (2)

FacilityCityRegionStatus
University Hospital of Nîmes Nîmes Gard Not Yet Recruiting
University Hospital of Montpellier Montpellier Hérault Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06650137 on ClinicalTrials.gov ↗ ← All trials in France