Diaphragmatic Atrophy Related to Mechanical Ventilation (ECHODIAPH)

Ultrasound Observation of Diaphragmatic Atrophy Related to Mechanical Ventilation A Prospective Monocentric Study in Intensive Care Unit

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.

Study Overview

• Status: Completed
• Conditions: Septic Shock; Acute Respiratory Distress
• Intervention / Treatment: Device: Ultrasound; Device: Ultrasound; Other: Neuromyopathy score; Other: Respiratory performances

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Ultrasound; An ultrasound of the right diaphragm will be performed on day 1, day 3, day 5 and day 10; Device: Ultrasound; An ultrasound of the pectoral muscle will be performed on day 1, day 3, day 5 and day 10; Other: Neuromyopathy score; A neuromyopathy score will be assessed on the extubation day; 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
Active Comparator: 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	Device: Ultrasound; An ultrasound of the right diaphragm will be performed on day 1, day 3, day 5 and day 10; Device: Ultrasound; An ultrasound of the pectoral muscle will be performed on day 1, day 3, day 5 and day 10; Other: Neuromyopathy score; A neuromyopathy score will be assessed on the extubation day; 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
Active Comparator: 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	Device: Ultrasound; An ultrasound of the right diaphragm will be performed on day 1, day 3, day 5 and day 10; Device: Ultrasound; An ultrasound of the pectoral muscle will be performed on day 1, day 3, day 5 and day 10; Other: Neuromyopathy score; A neuromyopathy score will be assessed on the extubation day; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from day 1 diaphragm thickness at day 3 and day 5	Diaphragm thickness measured by ultrasound	1 day, 3 days and 5 days after introduction of Mechanical Ventilation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2013
• Primary Completion (Actual): December 17, 2015
• Study Completion (Actual): December 22, 2015

Study Registration Dates

• First Submitted: April 29, 2016
• First Submitted That Met QC Criteria: May 9, 2016
• First Posted (Estimated): May 10, 2016

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Mechanical Ventilation
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: SJSL12013