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Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department (EDDRAPro)

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: NCT02273687
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief Summary:
The main objective of this study is to show that "diaphragmatic excursion measures upon emergency admission" (CDA values) on patients with acute respiratory failure are predictive of the need to use mechanical ventilation (invasive or non-) in the first four hours.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Adult Device: Vivid S6 GE Ultrasound Not Applicable

Detailed Description:

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. Measurement of diaphragmatic excursion by M-mode ultrasound [ Time Frame: Day 0, baseline ]
    in centimeters

  2. Use of ventilation within the first 4 hours [ Time Frame: Day 0, baseline + 4 hours ]
    yes/no


Secondary Outcome Measures :
  1. Measurement of diaphragmatic excursion by M-mode ultrasound [ Time Frame: Day 0, baseline + 4 hours ]
    in centimeters

  2. Acute respiratory distress signs within the first 4 hours [ Time Frame: Day 0, baseline + 4 hours ]
    yes/no

  3. Signs of respiratory re aggravation at 24 hours [ Time Frame: Day 1 ]
    yes/no

  4. Diagnosis [ Time Frame: Day 1 ]
    qualitative variable: decompensated COPD, OAP, pneumonia, asthma, or pleural pathology



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has given informed consent (and signed the consent form) or, in case of an emergency situation, an investigator has committed to obtaining the consent of the patient as soon as his/her condition permits
  • Patient affiliated with or beneficiary of a health insurance plan
  • Acute Respiratory Distress (DRA) defined by: (1) respiratory rate > 25 and/or signs of struggle and hypoxia AND (2) SpO2 values < 90% and/or [pH < 7.35 and pCO2 > 6 kPa (45 mm Hg)]
  • Breathing spontaneously (no ventilation)

Exclusion Criteria:

  • Patient currently participating in or having participated in another interventional study in the previous three months, or patient in an exclusion period determined by a previous study
  • Patient under judicial protection or any kind of guardianship
  • Refusal to sign the consent
  • Patient pregnant, parturient, or lactating
  • Neurological or neuromuscular disease modifying the operation of the diaphragm without any decompensation (Polyneuropathy, Lou Gehrig's disease, Myasthenia ...)
  • Patient who received mechanical ventilation at home
  • Patient who received treatment by mechanical ventilation during the pre-hospitalization care phase
  • Patient admitted with respiratory failure requiring immediate installation of a mechanical ventilation and thus not allowing the performance of two ultrasound measurements
  • Patient suffering from a pneumothorax

Information from the National Library of Medicine

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


Locations
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France
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
CH de Perpignan - Hôpital Saint Jean
Perpignan, France, 66046
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Xavier Bobbia, MD Centre Hospitalier Universitaire de Nîmes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02273687    
Other Study ID Numbers: LOCAL/20143/XBAC-01
2014-A00511-46 ( Other Identifier: RCB number )
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
diaphragm movement
ultrasound
emergency room
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Emergencies
Disease Attributes
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury