Reproductibility of TM-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the ER (EDDRA-Repro)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01743105|
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : March 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Distress Syndrome, Adult||Procedure: Diaphragm excursion measures 1 Procedure: Diaphragm excursion measures 2||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reproductibility of Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the Emergency Room|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
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.
- Diaphragmatic excursion, first measure by investigator 1 [ Time Frame: Baseline (day 0) ]in centimeters
- Diaphragmatic excursion, first measure by investigator 2 [ Time Frame: Baseline (day 0) ]in centimeters
- Time necessary to measure diaphragm movement amplitude (minutes) [ Time Frame: Baseline (day 0) ]
- Feasibility (yes/no) [ Time Frame: Baseline (day 0) ]We were able to perform the required measurements (yes/no)
- Diaphragmatic excursion, second measure by investigator 1 [ Time Frame: Baseline (day 0) ](centimeters)
- Diaphragmatic excursion, second measure by investigator 2 [ Time Frame: Baseline (day 0) ](centimeters)
- Age [ Time Frame: Baseline (day 0) ]
- Sexe [ Time Frame: Baseline (day 0) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743105
|CHU de Nîmes - Hôpital Universitaire Carémeau|
|Nîmes Cedex 09, Gard, France, 30029|
|Principal Investigator:||Xavier Bobbia, MD||Centre Hospitalier Universitaire de Nîmes|