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

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome, Adult
• Interventions: Procedure: Diaphragm excursion measures 1; Procedure: Diaphragm excursion measures 2

• Registration Number: NCT01743105
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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).

Study Timeline

• Study First Submitted: 2012-12-04
• Study First Submitted QC: 2012-12-05
• Study First Posted: 2012-12-06
• Study Start: 2013-08
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study population	Diaphragm excursion measures 2	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
Study population	Diaphragm excursion measures 1	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

Primary Outcome Measures

Name	Time	Method
Diaphragmatic excursion, first measure by investigator 1	Baseline (day 0)	in centimeters
Diaphragmatic excursion, first measure by investigator 2	Baseline (day 0)	in centimeters

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, Gard, France