Prevalence, Impact and Reversibility of Acute Diaprhagmatic Dysfunction in Acute Respiratory Detresse (PIRD-DRA)
Primary Purpose
Respiratory Distress Syndrome,Adult
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ultrasound examination
Sponsored by
About this trial
This is an interventional diagnostic trial for Respiratory Distress Syndrome,Adult
Eligibility 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
Sites / Locations
- CHU de NiceRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ultrasound examination
Arm Description
Assess the prevalence of acute diaphragmatic dysfunction by ultrasound
Outcomes
Primary Outcome Measures
Thickening fraction
Measurement of the thickening fraction by diaphragmatic ultrasound
Secondary Outcome Measures
Full Information
NCT ID
NCT04106128
First Posted
September 25, 2019
Last Updated
November 20, 2019
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT04106128
Brief Title
Prevalence, Impact and Reversibility of Acute Diaprhagmatic Dysfunction in Acute Respiratory Detresse
Acronym
PIRD-DRA
Official Title
Prevalence, Impact and Reversibility of Acute Diaprhagmatic Dysfunction in Acute Respiratory Detresse Measured by Diaphragmatic Echogaphy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 5, 2019 (Actual)
Primary Completion Date
October 5, 2020 (Anticipated)
Study Completion Date
October 5, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome,Adult
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
201 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ultrasound examination
Arm Type
Experimental
Arm Description
Assess the prevalence of acute diaphragmatic dysfunction by ultrasound
Intervention Type
Diagnostic Test
Intervention Name(s)
ultrasound examination
Intervention Description
Measuring the thickening fraction by diaphragmatic ultrasound of acute diaphragmatic dysfunction in patients admitted for acute respiratory distress
Primary Outcome Measure Information:
Title
Thickening fraction
Description
Measurement of the thickening fraction by diaphragmatic ultrasound
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Céline SANFIORENZO, MD
Phone
492038057
Ext
+33
Email
sanfiorenzo.c@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Céline SANFIORENZO, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline SANFIORENZO, MD
12. IPD Sharing Statement
Learn more about this trial
Prevalence, Impact and Reversibility of Acute Diaprhagmatic Dysfunction in Acute Respiratory Detresse
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