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

NCT03846934 | Terminated

• 1 other identifier: 87RI18_032 (POCUYTO)
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Clinically relevant Pleural Effusions (PE)

  Number and proportion of ARF patients for whom the thoracic ultrasonography realized in ED shows a clinically relevant PE (\> 2cm)

  Day 1

Secondary Outcomes (2)

• Inter-pleural distance to the inspiration

  Day 1

• Additional diagnostic elements

  Day 1

Study Arms (1)

Ultrasonography thoracic

Ultrasonography thoracic

Device: Ultrasonography thoracic

Interventions

Ultrasonography thoracic 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.

Ultrasonography thoracic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient admitted to ED and presenting with clinical signs of ARF

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

CHU de Limoges

Limoges, 87042, France

Location

MeSH Terms

Conditions

Pleural Effusion; Emergencies

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 20, 2019
• Study Start: December 3, 2019
• Primary Completion: August 18, 2021
• Study Completion: August 18, 2021
• Last Updated: October 7, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)