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

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Completed

CT.gov ID

NCT01743105

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome, Adult	Procedure: Diaphragm excursion measures 1 Procedure: Diaphragm excursion measures 2	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study population 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 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. Procedure: 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.

Arm

Intervention/Treatment

Experimental: Study population

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

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.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Age [Baseline (day 0)]
Sexe [Baseline (day 0)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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