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

Respiratory Distress Syndrome, Adult Clinical Trial

— EDDRA-Repro  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743105
• Other study ID #: LOCAL/2012/XBAC-01
• Secondary ID: 2012-A01094-39Bo
• Status: Completed
• Phase: N/A
• First received: December 4, 2012
• Last updated: March 25, 2015
• Start date: August 2013
• Est. completion date: January 2014

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Procedure:
• Diaphragm excursion measures 1
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.
• Diaphragm excursion measures 2
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.

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age		Baseline (day 0)	No
Other	Sexe		Baseline (day 0)	No
Primary	Diaphragmatic excursion, first measure by investigator 1	in centimeters	Baseline (day 0)	No
Primary	Diaphragmatic excursion, first measure by investigator 2	in centimeters	Baseline (day 0)	No
Secondary	Time necessary to measure diaphragm movement amplitude (minutes)		Baseline (day 0)	No
Secondary	Feasibility (yes/no)	We were able to perform the required measurements (yes/no)	Baseline (day 0)	No
Secondary	Diaphragmatic excursion, second measure by investigator 1	(centimeters)	Baseline (day 0)	No
Secondary	Diaphragmatic excursion, second measure by investigator 2	(centimeters)	Baseline (day 0)	No