Diaphragmatic Atrophy Related to Mechanical Ventilation

Not Applicable

Completed

• Conditions: Septic Shock; Acute Respiratory Distress
• Interventions: Device: Ultrasound; Other: Neuromyopathy score; Other: Respiratory performances

• Registration Number: NCT02766946
• Lead Sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon

Brief Summary

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

Not available

Study Timeline

• Study Start: 2013-06-24
• Primary Completion: 2015-12-17
• Study Completion: 2015-12-22
• Study First Submitted: 2016-04-29
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-invasive Ventilation	Ultrasound	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
Mechanical Ventilation	Ultrasound	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
Mechanical Ventilation	Neuromyopathy score	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
Non-invasive Ventilation	Neuromyopathy score	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
Spontaneous Ventilation	Ultrasound	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
Spontaneous Ventilation	Respiratory performances	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
Mechanical Ventilation	Respiratory performances	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
Non-invasive Ventilation	Respiratory performances	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
Spontaneous Ventilation	Neuromyopathy score	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

Primary Outcome Measures

Name	Time	Method
Change from day 1 diaphragm thickness at day 3 and day 5	1 day, 3 days and 5 days after introduction of Mechanical Ventilation	Diaphragm thickness measured by ultrasound

Secondary Outcome Measures

Name	Time	Method
Diaphragmatic strength	intraoperative	Relation between diaphragmatic atrophy and decrease of diaphragmatic strength
MRC score (Medical Research Council)	intraoperative	Relation between diaphragmatic atrophy and decrease of diaphragmatic strength
Respiratory rate	10 days after start of ventilatory support
Highest inspiratory pressure level	10 days after start of ventilatory support
Pectoralis muscle thickness measured by ultrasound	10 days after start of ventilatory support	To compare the importance of this atrophy to those of diaphragmatic muscle
Early or late extubation failure rate (extubation performed before or after 48 hours)	The last day of hospitalisation	Relation between diaphragmatic atrophy importance and premature (\<48h) or late extubation failure
Length of ventilation in hours	10 days after start of ventilatory support
Drug administration	10 days after start of ventilatory support	Presence of drug administration such as curare, corticoid or sedative. If yes : number of days with treatment
Total positive end expiratory pressure	10 days after start of ventilatory support
Highest expiratory pressure level	10 days after start of ventilatory support
External positive end expiratory pressure	10 days after start of ventilatory support
Volume of exhaled air	10 days after start of ventilatory support
Ventilatory mode	10 days after start of ventilatory support	Ventilatory mode (controlled ventilation, pressure support ventilation)
Diaphragm thickness measured by ultrasound	10 days after introduction of Mechanical Ventilation
Type of ventilatory support	10 days after start of ventilatory support	Define which type of ventilatory support is used (mechanical ventilation, non-invasive ventilation, or spontaneous ventilation)