Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department (EDDRAPro)
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|ClinicalTrials.gov Identifier: NCT02273687|
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : January 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Distress Syndrome, Adult||Device: Vivid S6 GE Ultrasound||Not Applicable|
The secondary objectives of this study are:
A-determine a prognostic threshold for diaphragmatic excursion measures able to predict the use of mechanical ventilation (invasive or not) in the first four hours.
B-to study the association between CDA values and persistence of respiratory distress during the first 4 hours of care among patients who, at 4 hours, are not mechanically ventilated.
C-to study the association between CDA values and respiratory re-exacerbation or a continuing need for mechanical ventilation during the 24 first hours after admission to the emergency room D-to study the association between diaphragmatic excursion measures made after initial emergency care (at 4 hours; =CDH4), and the persistence of respiratory distress at 4 hours, in patients who at 4 hours are not mechanically ventilated.
E-to study the association between CDH4 values and respiratory re-exacerbation during the 24 first hours after admission to the emergency room among patients who, at 4 hours, are not mechanically ventilated F-to study the association between changes in values of diaphragmatic excursion measure before and after initial emergency care (CDA → CDH4) and respiratory re-exacerbation during the 24 first hours after admission to the emergency room among patients who, at 4 hours, are not mechanically ventilated.
G-analyze patient outcomes by subgroup according to diagnosis (decompensated COPD, OAP, lung disease, asthma, pleural disease).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Analysis of Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department: Predicting Respiratory Prognosis|
|Actual Study Start Date :||October 29, 2014|
|Actual Primary Completion Date :||September 29, 2017|
|Actual Study Completion Date :||September 29, 2017|
Experimental: Prognostic 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.
Intervention: Diaphragmatic ultrasound
Device: Vivid S6 GE Ultrasound
Diaphragmatic ultrasound will be performed by the physician supporting the patient on arrival and also at 4 hours later in the beginning of therapeutic management. The patient will be monitored for 24 hours following inclusion.
The exams will all be done with the same ultrasound system (Vivid S6 GE Ultrasound) and a phased array probe, also called a cardiac probe.
- Measurement of diaphragmatic excursion by M-mode ultrasound [ Time Frame: Day 0, baseline ]in centimeters
- Use of ventilation within the first 4 hours [ Time Frame: Day 0, baseline + 4 hours ]yes/no
- Measurement of diaphragmatic excursion by M-mode ultrasound [ Time Frame: Day 0, baseline + 4 hours ]in centimeters
- Acute respiratory distress signs within the first 4 hours [ Time Frame: Day 0, baseline + 4 hours ]yes/no
- Signs of respiratory re aggravation at 24 hours [ Time Frame: Day 1 ]yes/no
- Diagnosis [ Time Frame: Day 1 ]qualitative variable: decompensated COPD, OAP, pneumonia, asthma, or pleural pathology
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): NCT02273687
|CHRU de Nîmes - Hôpital Universitaire Carémeau|
|Nîmes Cedex 09, France, 30029|
|CH de Perpignan - Hôpital Saint Jean|
|Perpignan, France, 66046|
|Principal Investigator:||Xavier Bobbia, MD||Centre Hospitalier Universitaire de Nîmes|