Skip to main content
Clinical Trials/NCT03846934
NCT03846934
Terminated
Not Applicable

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

University Hospital, Limoges1 site in 1 country167 target enrollmentDecember 3, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pleural Effusion
Sponsor
University Hospital, Limoges
Enrollment
167
Locations
1
Primary Endpoint
Clinically relevant Pleural Effusions (PE)
Status
Terminated
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 3, 2019
End Date
August 18, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Limoges
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Clinically relevant Pleural Effusions (PE)

Time Frame: Day 1

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

Secondary Outcomes

  • Additional diagnostic elements(Day 1)
  • Inter-pleural distance to the inspiration(Day 1)

Study Sites (1)

Loading locations...

Similar Trials