POCUYTO: Positive and Quantitative Diagnosis of Pleural Effusions by Thoracic Ultrasonography in Patients With Acute Respiratory Failure in the Emergency Department

Sponsor

University Hospital, Limoges (Other)

Overall Status

Terminated

CT.gov ID

NCT03846934

Collaborator

(none)

167

Enrollment

Location

20.5

Actual Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Acute respiratory failure (ARF) is a frequent reason for consulting in the Emergency Department (ED) and one of the major clinical problems prompting admission in intensive care unit. In the ED, evaluation of an ARF is mainly based on clinical examination and frontal chest x-ray performed to the patient bedside. This practice has a limited diagnostic capacity due to a lack of specificity of clinical and radiological semiology, especially in the polypathological patient. Thoracic ultrasonography provides morphological information regrouped as a syndrome (interstitial syndrome, alveolar condensation, pneumothorax) and allows the identification of pleural effusions (PE). The PE diagnosis is easy, quick, and relies on two-dimensional ultrasound imaging. Compared to CT scan, which remains the reference examination although ill-suited in the context of emergency, thoracic ultrasonography has a sensitivity and specificity greater than 90% for pleural liquid (PL) diagnosis. In addition, thoracic ultrasonography is used to assess the volume of PL, determine its nature and guide the pleural puncture with higher performance than chest x-ray. The semi-quantitative evaluation of PEs has been validated in patients with mechanical ventilation hospitalized in intensive care unit. On the other hand, few data on the prevalence and quantification of PL for hospitalized patients in ED for an ARF are currently available.

Thus, the objective of this study is to evaluate the prevalence and severity of the PL identified by thoracic ultrasonography in patients admitted to the ED for an ARF by emergency physicians with ultrasound skills recommended by the French Society of Emergency Medicine.

Condition or Disease	Intervention/Treatment	Phase
Pleural Effusion Ultrasonography Thoracic Acute Respiratory Failure Emergencies	Device: Ultrasonography thoracic

Detailed Description

Acute respiratory failure (ARF) is a frequent reason for consulting in the Emergency Department (ED) and one of the major clinical problems prompting admission in intensive care unit. In the ED, evaluation of an ARF is mainly based on clinical examination and frontal chest x-ray performed to the patient bedside. This practice has a limited diagnostic capacity due to a lack of specificity of clinical and radiological semiology, especially in the polypathological patient. Thoracic ultrasonography provides morphological information regrouped as a syndrome (interstitial syndrome, alveolar condensation, pneumothorax) and allows the identification of pleural effusions (PE). The PE diagnosis is easy, quick, and relies on two-dimensional ultrasound imaging. Compared to CT scan, which remains the reference examination although ill-suited in the context of emergency, thoracic ultrasonography has a sensitivity and specificity greater than 90% for PL diagnosis. In addition, thoracic ultrasonography is used to assess the volume of PL, determine its nature and guide the pleural puncture with higher performance than chest x-ray. The semi-quantitative evaluation of PEs has been validated in patients with mechanical ventilation hospitalized in intensive care unit. On the other hand, few data on the prevalence and quantification of PL for hospitalized patients in ED for an ARF are currently available.

Study Design

Study Type:

Observational

Actual Enrollment :

167 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Positive and Quantitative Diagnosis of Pleural Effusions by Thoracic Ultrasonography in Patients With Acute Respiratory Failure in the Emergency Department

Actual Study Start Date :

Dec 3, 2019

Actual Primary Completion Date :

Aug 18, 2021

Actual Study Completion Date :

Aug 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Ultrasonography thoracic Ultrasonography thoracic	Device: Ultrasonography thoracic Thoracic ultrasonography will be performed as soon as possible after admission to the ED, without delaying the start of treatment and in addition to routine thoracic radiography.

Arm

Intervention/Treatment

Ultrasonography thoracic

Device: Ultrasonography thoracic

Thoracic ultrasonography will be performed as soon as possible after admission to the ED, without delaying the start of treatment and in addition to routine thoracic radiography.

Outcome Measures

Primary Outcome Measures

Clinically relevant Pleural Effusions (PE) [Day 1]
Number and proportion of ARF patients for whom the thoracic ultrasonography realized in ED shows a clinically relevant PE (> 2cm)

Secondary Outcome Measures

Inter-pleural distance to the inspiration [Day 1]
Measuring of the inter-pleural distance to the inspiration (patient in spontaneous ventilation) in cross-section
Additional diagnostic elements [Day 1]
Number and proportion of patients for whom the thoracic ultrasound provides additional diagnostic evidence in comparison to clinical examination and the standard thoracic radiography in frontal bed, ie: Presence of an PE Abundant PE> 800 mL Or any other pleuro-parenchymal abnormalities identified by ultrasound (pneumothorax, condensation of lung parenchyma ...) and not on standard radiography