Clinical trial NCT01743105: Reproductibility of TM-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the ER
Official title: Reproductibility of Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the Emergency Room
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome, Adult
Keywords: diaphragm movement
ultrasound
emergency room
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Diaphragmatic excursion, first measure by investigator 1
timeFrame: Baseline (day 0)
measure: Diaphragmatic excursion, first measure by investigator 2
timeFrame: Baseline (day 0)
Secondary outcomes:
measure: Time necessary to measure diaphragm movement amplitude (minutes)
timeFrame: Baseline (day 0)
measure: Feasibility (yes/no)
timeFrame: Baseline (day 0)
measure: Diaphragmatic excursion, second measure by investigator 1
timeFrame: Baseline (day 0)
measure: Diaphragmatic excursion, second measure by investigator 2
timeFrame: Baseline (day 0)
Other outcomes:
measure: Age
timeFrame: Baseline (day 0)
measure: Sexe
timeFrame: Baseline (day 0)
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Xavier Bobbia, MD
role: PRINCIPAL_INVESTIGATOR
References: