Clinical trial NCT02766946: Diaphragmatic Atrophy Related to Mechanical Ventilation
Official title: Ultrasound Observation of Diaphragmatic Atrophy Related to Mechanical Ventilation A Prospective Monocentric Study in Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Acute Respiratory Distress
Keywords: Mechanical Ventilation
Lead sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from day 1 diaphragm thickness at day 3 and day 5
timeFrame: 1 day, 3 days and 5 days after introduction of Mechanical Ventilation
Secondary outcomes:
measure: Diaphragm thickness measured by ultrasound
timeFrame: 10 days after introduction of Mechanical Ventilation
measure: Type of ventilatory support
timeFrame: 10 days after start of ventilatory support
measure: Ventilatory mode
timeFrame: 10 days after start of ventilatory support
measure: Pectoralis muscle thickness measured by ultrasound
timeFrame: 10 days after start of ventilatory support
measure: Diaphragmatic strength
timeFrame: intraoperative
measure: Early or late extubation failure rate (extubation performed before or after 48 hours)
timeFrame: The last day of hospitalisation
measure: MRC score (Medical Research Council)
timeFrame: intraoperative
measure: Length of ventilation in hours
timeFrame: 10 days after start of ventilatory support
measure: Drug administration
timeFrame: 10 days after start of ventilatory support
measure: Total positive end expiratory pressure
timeFrame: 10 days after start of ventilatory support
measure: External positive end expiratory pressure
timeFrame: 10 days after start of ventilatory support
measure: Respiratory rate
timeFrame: 10 days after start of ventilatory support
measure: Highest inspiratory pressure level
timeFrame: 10 days after start of ventilatory support
measure: Highest expiratory pressure level
timeFrame: 10 days after start of ventilatory support
measure: Volume of exhaled air
timeFrame: 10 days after start of ventilatory support
Other outcomes:
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