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

NCT ID: NCT03846934

Last Updated: 2021-10-07

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 167 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-03
• Study Completion Date: 2021-08-18

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.

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.

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.

Conditions

Pleural Effusion; Ultrasonography; Thoracic; Acute Respiratory Failure; Emergencies

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Ultrasonography thoracic

Ultrasonography thoracic

Ultrasonography thoracic

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient admitted to the ED
• AND Age >= 18 years
• AND affiliated or beneficiary to a social security scheme
• AND with clinical signs of ARF:

• Cyanosis, mottling, encephalopathy
• Respiratory exhaustion (thoraco abdominal balancing, accessory muscle play)
• Pulse oxygen saturation (SpO2) <92% in the air
• AND/OR showing biological signs of ARF:

• Arterial oxygen pressure (PaO2) <60 mmHg
• Or PaO2 / fraction of inspired oxygen (FiO2) ratio <400.

Exclusion Criteria

• Patient moribund or for whom a limitation of the care is envisaged
• Pregnant woman
• Absence of exploitable ultrasound image for any reason.

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

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Limoges

Limoges, , France

Countries

France

Other Identifiers

87RI18_032 (POCUYTO)

Identifier Type: -

Identifier Source: org_study_id