Diaphragmatic Atrophy Related to Mechanical Ventilation

Septic Shock Clinical Trial

— ECHODIAPH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02766946
• Other study ID #: SJSL12013
• Status: Completed
• Phase: N/A
• Start date: June 24, 2013
• Est. completion date: December 22, 2015

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Saint Joseph Saint Luc de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: December 22, 2015
• Est. primary completion date: December 17, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Distress
• Atrophy
• Septic Shock

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Saint Joseph Saint Luc de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Diaphragm thickness measured by ultrasound		10 days after introduction of Mechanical Ventilation
Secondary	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
Secondary	Ventilatory mode	Ventilatory mode (controlled ventilation, pressure support ventilation)	10 days after start of ventilatory support
Secondary	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
Secondary	Diaphragmatic strength	Relation between diaphragmatic atrophy and decrease of diaphragmatic strength	intraoperative
Secondary	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
Secondary	MRC score (Medical Research Council)	Relation between diaphragmatic atrophy and decrease of diaphragmatic strength	intraoperative
Secondary	Length of ventilation in hours		10 days after start of ventilatory support
Secondary	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
Secondary	Total positive end expiratory pressure		10 days after start of ventilatory support
Secondary	External positive end expiratory pressure		10 days after start of ventilatory support
Secondary	Respiratory rate		10 days after start of ventilatory support
Secondary	Highest inspiratory pressure level		10 days after start of ventilatory support
Secondary	Highest expiratory pressure level		10 days after start of ventilatory support
Secondary	Volume of exhaled air		10 days after start of ventilatory support