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Trial record 46 of 80911 for:    measured

PREVALENCE, IMPACT AND REVERSIBILITY OF ACUTE DIAPRHAGMATIC DYSFUNCTION IN ACUTE RESPIRATORY DETRESSE MEASURED BY DIAPHRAGMATIC ECHOGRAPHY (PIRD-DRA)

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ClinicalTrials.gov Identifier: NCT04106128
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:

The diaphragm is a fine striated muscle with both extra respiratory and respiratory functions. It does most of the breathing work in interaction with the accessory respiratory muscles, the rib cage and the abdomen. Its activity can be measured by the transdiaphragmatic pressure generated by the magnetic stimulation of phrenic nerves (gold standard). It has been shown in the literature that diaphragmatic ultrasound, via the measurement of diaphragmatic excursion and especially the thickening fraction, is an easily accessible, non-invasive, reproducible and relevant technique for evaluating acute diaphragmatic dysfunction in resuscitation patients.

The objective of this project is to evaluate the prevalence of diaphragmatic dysfunction at admission in patients hospitalized in intensive care / respiratory intensive care unit for hypercapnic and/or hypoxic acute respiratory distress and requiring ventilatory support by non-invasive ventilation or high flow oxygen therapy. A subgroup analysis will then be carried out on 3 populations:

  • Hypercapnic exacerbation of chronic obstructive pulmonary disease
  • Hypoxic acute respiratory distress on infectious lung disease
  • Acute pulmonary edema

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome,Adult Diagnostic Test: ultrasound examination Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 201 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PREVALENCE, IMPACT AND REVERSIBILITY OF ACUTE DIAPRHAGMATIC DYSFUNCTION IN ACUTE RESPIRATORY DETRESSE MEASURED BY DIAPHRAGMATIC ECHOGRAPHY
Actual Study Start Date : April 5, 2019
Estimated Primary Completion Date : October 5, 2020
Estimated Study Completion Date : October 5, 2020


Arm Intervention/treatment
Experimental: ultrasound examination
Assess the prevalence of acute diaphragmatic dysfunction by ultrasound
Diagnostic Test: ultrasound examination
Measuring the thickening fraction by diaphragmatic ultrasound of acute diaphragmatic dysfunction in patients admitted for acute respiratory distress




Primary Outcome Measures :
  1. Thickening fraction [ Time Frame: 48 hours ]
    Measurement of the thickening fraction by diaphragmatic ultrasound



Information from the National Library of Medicine

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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:

  • Hospitalization for acute respiratory distress management
  • Etiological diagnosis either:
  • Exacerbation of chronic obstructive pulmonary disease
  • Infectious pneumonitis
  • Acute pulmonary edema
  • Need for a ventilatory support by either:
  • Non-invasive ventilation
  • High flow oxygen therapy (flow rate > 40L/min and oxygen inspired fraction > 40%)
  • Mask oxygen therapy with flow rate > 5L/min

Exclusion Criteria:

  • Exacerbation of interstitial pathology / pulmonary fibrosis
  • Deformation of the thoracic cage
  • Neurodegenerative pathology
  • Need for oro-tracheal intubation from the beginning for mechanical ventilation
  • Contraindication to Non-invasive Ventilation
  • Patients undergoing diaphragmatic rehabilitation
  • Immunocompromised patients
  • History of known diaphragmatic dysfunction

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): NCT04106128


Contacts
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Contact: Céline SANFIORENZO, MD 492038057 ext +33 sanfiorenzo.c@chu-nice.fr

Locations
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France
CHU de Nice Recruiting
Nice, France, 06003
Contact: Céline SANFIORENZO, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: Céline SANFIORENZO, MD Centre Hospitalier Universitaire de Nice

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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT04106128     History of Changes
Other Study ID Numbers: 18-PP-15
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury