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

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

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Key information

Conditions

Respiratory Distress Syndrome,Adult Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, 06003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound examination

Diagnostic Test

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

Primary outcomes

Thickening fraction

Time frame: 48 hours

Measurement of the thickening fraction by diaphragmatic ultrasound

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Prevalence, Impact and Reversibility of Acute Diaprhagmatic Dysfunction in Acute Respiratory Detresse Measured by Diaphragmatic Echogaphy

Acronym: PIRD-DRA

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Sep 26, 2019
Registry last updated: Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed