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

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.

Study Overview

• Status: Terminated
• Conditions: Emergencies; Ultrasonography; Pleural Effusion; Acute Respiratory Failure; Thoracic
• Intervention / Treatment: 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.

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.

• Study Type: Observational
• Enrollment (Actual): 167

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87042
    • CHU de Limoges

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient admitted to ED and presenting with clinical signs of ARF

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-pleural distance to the inspiration	Measuring of the inter-pleural distance to the inspiration (patient in spontaneous ventilation) in cross-section	Day 1
Additional diagnostic elements	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	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2019
• Primary Completion (Actual): August 18, 2021
• Study Completion (Actual): August 18, 2021

Study Registration Dates

• First Submitted: February 18, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Ultrasonography; Thoracic; Acute Respiratory Failure; Emergencies; Pleural Effusion
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease Attributes; Pleural Diseases; Emergencies; Respiratory Insufficiency; Respiratory Distress Syndrome; Pleural Effusion
• Other Study ID Numbers: 87RI18_032 (POCUYTO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No