Prevalence, Impact and Reversibility of Acute Diaprhagmatic Dysfunction in Acute Respiratory Detresse

NCT04106128 | Completed

• 1 other identifier: 18-PP-15
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Distress Syndrome,Adult

Outcome Measures

Primary Outcomes (1)

• Thickening fraction

  Measurement of the thickening fraction by diaphragmatic ultrasound

  48 hours

Study Arms (1)

ultrasound examination

EXPERIMENTAL

Assess the prevalence of acute diaphragmatic dysfunction by ultrasound

Diagnostic Test: ultrasound examination

Interventions

ultrasound examination DIAGNOSTIC_TEST

Measuring the thickening fraction by diaphragmatic ultrasound of acute diaphragmatic dysfunction in patients admitted for acute respiratory distress

ultrasound examination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06003, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Céline SANFIORENZO, MD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 26, 2019
• Study Start: April 5, 2019
• Primary Completion: October 5, 2022
• Study Completion: October 5, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

FR (1)