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

NCT ID: NCT04106128

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-05

Study Completion Date

2022-10-05

Brief Summary

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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

Detailed Description

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Conditions

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Respiratory Distress Syndrome,Adult

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ultrasound examination

Assess the prevalence of acute diaphragmatic dysfunction by ultrasound

Group Type EXPERIMENTAL

ultrasound examination

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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ultrasound examination

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Céline SANFIORENZO, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

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CHU de Nice

Nice, , France

Site Status

Countries

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France

Other Identifiers

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18-PP-15

Identifier Type: -

Identifier Source: org_study_id

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