Reproductibility of TM-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the ER

Study Overview
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Brief Summary
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The main objective of this study is to evaluate the inter-rater reproducibility of diaphragmatic excursion measures via time-motion-mode ultrasound (evaluation performed on the first measure) in patients experiencing acute respiratory distress emergencies.

Detailed Description
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The secondary objectives of this study are: To assess the feasibility of measuring the diaphragmatic excursion in the context of emergency management (ratio of measured patients / included patients). To evaluate the time required for the measurement. To assess the intra-rater reproducibility of measurements of diaphragmatic excursion (comparison of first and second measures).

Official Title
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Reproductibility of Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the Emergency Room

Conditions
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Respiratory Distress Syndrome, Adult

Intervention / Treatment
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* Procedure: Diaphragm excursion measures 1
* Procedure: Diaphragm excursion measures 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient has acute respiratory distress defined by a respiratory rate > 25, and / or signs of struggle and hypoxia, oxygen saturation (SpO2) <90% and / or pH <7.35 and carbon dioxide partial pressure (pCO2) > 6 kPa (45 mm Hg) The patient breathes spontaneously (no respirator) Exclusion Criteria: The patient is participating in another study The patient is in an exclusion period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The patient or his/her representative refuses to sign the consent It is impossible to correctly inform the patient, or to correctly inform his/her representative The patient is pregnant, parturient, or breastfeeding The patient has a neurological or neuromuscular disease that modifies diaphragm function/movement; this does not include cases of decompensation (polyradiculoneuropathy, Lou Gehrig's disease, Myasthenia ...). Patient admitted with respiratory support treatment in progress Patient admitted with respiratory failure requiring immediate implementation of mechanical ventilation, thus preventing ultrasound measurements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study population<br>The study population consists of patients treated for acute respiratory distress in the emergency department at the Nîmes University Hospital. See inclusion and exclusion criteria. Interventions: Diaphragm excursion measures 1, Diaphragm excursion measures 2 | Procedure: Diaphragm excursion measures 1<br>* A first diaphragm ultrasound study will be carried out by investigator 1. A Vivid S6 GE Ultrasound will be used, with a phased array cardiac probe.<br>Procedure: Diaphragm excursion measures 2<br>* A second diaphragm ultrasound study will be carried out immediately after Ultrasound 1, and by investigator 2. The results are blinded between investigators. A Vivid S6 GE Ultrasound will be used, with a phased array cardiac probe.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragmatic excursion, first measure by investigator 1 | in centimeters | Baseline (day 0) | 
| Diaphragmatic excursion, first measure by investigator 2 | in centimeters | Baseline (day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time necessary to measure diaphragm movement amplitude (minutes) |  | Baseline (day 0) | 
| Feasibility (yes/no) | We were able to perform the required measurements (yes/no) | Baseline (day 0) | 
| Diaphragmatic excursion, second measure by investigator 1 | (centimeters) | Baseline (day 0) | 
| Diaphragmatic excursion, second measure by investigator 2 | (centimeters) | Baseline (day 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diaphragm movement, ultrasound, emergency room