Clinical trial NCT03846934: Positive and Quantitative Diagnosis of Pleural Effusions by Thoracic Ultrasonography in Patients With Acute Respiratory Failure in the Emergency Department
Official title: Positive and Quantitative Diagnosis of Pleural Effusions by Thoracic Ultrasonography in Patients With Acute Respiratory Failure in the Emergency Department
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pleural Effusion
Ultrasonography
Thoracic
Acute Respiratory Failure
Emergencies
Keywords: Pleural Effusion
Ultrasonography
Thoracic
Acute Respiratory Failure
Emergencies
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient admitted to ED and presenting with clinical signs of ARF

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.

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.

Primary outcomes:
measure: Clinically relevant Pleural Effusions (PE)
timeFrame: Day 1
Secondary outcomes:
measure: Inter-pleural distance to the inspiration
timeFrame: Day 1
measure: Additional diagnostic elements
timeFrame: Day 1
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU de Limoges
Study officials:
References: