Evaluation of the Relevance of Diaphragmatic Stroke Ultrasound for the Etiological Diagnosis of Acute Respiratory Distress in an Emergency Department: a Prospective Multicenter Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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,
结局指标
主要结局
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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
次要结局
- 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)
- Assess the relevance of the TPE for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. (Negative likelihood ratio (%))(Baseline)
- Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department (Sensibility )(Baseline)
- Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency departmentSpecificity(Baseline)
- Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. Negative predictive values(Baseline)
- Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. Positive likelihood ratio(Baseline)
- Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. Negative likelihood ratio(Baseline)
- Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Sensibility(Baseline)
- Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Specificity(Baseline)
- Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive predictive values(Baseline)
- Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative predictive values(Baseline)
- Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive likelihood ratio(Baseline)
- Assess the relevance of PTS for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative likelihood ratio(Baseline)
- Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Sensibility(Baseline)
- Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Specificity(Baseline)
- Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive predictive values(Baseline)
- Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative predictive values(Baseline)
- Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive likelihood ratio(Baseline)
- Assess the relevance of IPT for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative likelihood ratio(Baseline)
- Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Sensibility(Baseline)
- Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Specificity(Baseline)
- Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive predictive values(Baseline)
- Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative predictive values(Baseline)
- Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Positive likelihood ratio(Baseline)
- Assess the relevance of TPE for the etiological diagnosis of COPD decompensation in patients managed for ARD in the emergency department. Negative likelihood ratio(Baseline)
- Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Sensibility(Baseline)
- Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Specificity(Baseline)
- Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive predictive values(Baseline)
- Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative predictive values(Baseline)
- Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive likelihood ratio(Baseline)
- Assess the relevance of PTS for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative likelihood ratio(Baseline)
- Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Sensibility(Baseline)
- Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Specificity(Baseline)
- Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive predictive values(Baseline)
- Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative predictive values(Baseline)
- Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive likelihood ratio(Baseline)
- Assess the relevance of IPT for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative likelihood ratio(Baseline)
- Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Sensibility(Baseline)
- Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Specificity(Baseline)
- Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive predictive values(Baseline)
- Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative predictive values(Baseline)
- Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Positive likelihood ratio(Baseline)
- Assess the relevance of TPE for the etiologic diagnosis of PAO in patients managed for ARD in the emergency department; Negative likelihood ratio(Baseline)
- Visually analyze the shape of the Diaphragmatic curves (DC) of patients seen for ARD in the emergency department and whose cause is mixed (association of at least two causes).(Baseline)
- Assessing the relevance of IPT for the etiological diagnosis of pneumopathy in patients managed for ARD in the emergency department. Positive predictive values(Baseline)