Diaphragmatic Atrophy Related to Mechanical Ventilation (ECHODIAPH)

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Status: Completed

Conditions: Acute Respiratory Distress; Septic Shock

Treatments: Other: Neuromyopathy score; Other: Respiratory performances; Device: Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT02766946

SJSL12013

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 3 patient groups

Mechanical Ventilation

Experimental group

Description:

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

Treatment:

Other: Neuromyopathy score

Device: Ultrasound

Device: Ultrasound

Other: Respiratory performances

Non-invasive Ventilation

Active Comparator group

Description:

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

Treatment:

Other: Neuromyopathy score

Device: Ultrasound

Device: Ultrasound

Other: Respiratory performances

Spontaneous Ventilation

Active Comparator group

Description:

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

Treatment:

Other: Neuromyopathy score

Device: Ultrasound

Device: Ultrasound

Other: Respiratory performances