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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Respiratory Distress Syndrome, Adult

Treatments: Procedure: Diaphragm excursion measures 1; Procedure: Diaphragm excursion measures 2

Study type: Interventional

Funder types: Other

Identifiers

NCT01743105

Bobbia EDDRA Repro (Other Identifier)

2012-A01094-39 (Other Identifier)

LOCAL/2012/XBAC-01

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Study population

Experimental group

Description:

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

Treatment:

Procedure: Diaphragm excursion measures 2

Procedure: Diaphragm excursion measures 1