Diaphragmatic Atrophy Related to Mechanical Ventilation

NCT ID: NCT02766946

Last Updated: 2024-04-04

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

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-24

Study Completion Date

2015-12-22

Brief Summary

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Ventilatory support during critical phase result in inactivity of respiratory muscles especially diaphragm muscle. These inactivity also result in change of contractile capability and quick muscular atrophy.

The aim of the study is to visualize the evolution of diaphragm thickness by echography during Mechanical Ventilation for patients with septic shock or acute respiratory distress syndrome and to compare with the evolution for patients under non-invasive ventilation and those with spontaneous ventilation. Measurements will be performed at day 1, day 5 and day 10 (if patient still under a mode of ventilation or in the unit).

The evolution of diaphragm thickness will also be compared to pectoralis muscle atrophy, which is not involved in ventilation, in order to assess respective effect of ventilatory inactivity and undernutrition linked to intensive care.

Detailed Description

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Conditions

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Septic Shock Acute Respiratory Distress

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Mechanical Ventilation

Evolution over time of Diaphragmatic and Pectoralis muscle atrophy under Mechanical Ventilation

Interventions :

* Ultrasound of the right diaphragm
* Ultrasound of the pectoral muscle
* Neuromyopathy score
* Respiratory performances

Group Type EXPERIMENTAL

Ultrasound

Intervention Type DEVICE

An ultrasound of the right diaphragm will be performed on day 1, day 3, day 5 and day 10

Ultrasound

Intervention Type DEVICE

An ultrasound of the pectoral muscle will be performed on day 1, day 3, day 5 and day 10

Neuromyopathy score

Intervention Type OTHER

A neuromyopathy score will be assessed on the extubation day

Respiratory performances

Intervention Type OTHER

An assessment of the respiratory performances will be done on the extubation day, including higher expiratory pressure, higher inspiratory pressure, and occlusion pressure

Non-invasive Ventilation

Evolution over time of Diaphragmatic and Pectoralis muscle atrophy under Non-invasive Ventilation

Interventions :

* Ultrasound of the right diaphragm
* Ultrasound of the pectoral muscle
* Neuromyopathy score
* Respiratory performances

Group Type ACTIVE_COMPARATOR

Ultrasound

Intervention Type DEVICE

An ultrasound of the right diaphragm will be performed on day 1, day 3, day 5 and day 10

Ultrasound

Intervention Type DEVICE

An ultrasound of the pectoral muscle will be performed on day 1, day 3, day 5 and day 10

Neuromyopathy score

Intervention Type OTHER

A neuromyopathy score will be assessed on the extubation day

Respiratory performances

Intervention Type OTHER

An assessment of the respiratory performances will be done on the extubation day, including higher expiratory pressure, higher inspiratory pressure, and occlusion pressure

Spontaneous Ventilation

Evolution over time of Diaphragmatic and Pectoralis muscle atrophy under Spontaneous Ventilation

Interventions :

* Ultrasound of the right diaphragm
* Ultrasound of the pectoral muscle
* Neuromyopathy score
* Respiratory performances

Group Type ACTIVE_COMPARATOR

Ultrasound

Intervention Type DEVICE

An ultrasound of the right diaphragm will be performed on day 1, day 3, day 5 and day 10

Ultrasound

Intervention Type DEVICE

An ultrasound of the pectoral muscle will be performed on day 1, day 3, day 5 and day 10

Neuromyopathy score

Intervention Type OTHER

A neuromyopathy score will be assessed on the extubation day

Respiratory performances

Intervention Type OTHER

An assessment of the respiratory performances will be done on the extubation day, including higher expiratory pressure, higher inspiratory pressure, and occlusion pressure

Interventions

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Ultrasound

An ultrasound of the right diaphragm will be performed on day 1, day 3, day 5 and day 10

Intervention Type DEVICE

Ultrasound

An ultrasound of the pectoral muscle will be performed on day 1, day 3, day 5 and day 10

Intervention Type DEVICE

Neuromyopathy score

A neuromyopathy score will be assessed on the extubation day

Intervention Type OTHER

Respiratory performances

An assessment of the respiratory performances will be done on the extubation day, including higher expiratory pressure, higher inspiratory pressure, and occlusion pressure

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years old
* Group 1 : under Mechanical Ventilation (time of Mechanical Ventilation for at least 5 days)
* Group 2 : under Non-invasive Ventilation
* Group 3 : Spontaneous Ventilation
* Non opposition of patient (Groups 2 and 3) or non-opposition of patient family member (Group 1)

Exclusion Criteria

* Known diaphragmatic paralysis
* Neurologic pathology with motor deficit
* Pregnancy or breast-feeding woman
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Saint Joseph Saint Luc de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SJSL12013

Identifier Type: -

Identifier Source: org_study_id

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