Diaphragmatic Atrophy Related to Mechanical Ventilation

Overview

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.

Full Title of Study: “Ultrasound Observation of Diaphragmatic Atrophy Related to Mechanical Ventilation A Prospective Monocentric Study in Intensive Care Unit”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2016

Interventions

  • 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

Arms, Groups and Cohorts

  • 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
  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Saint Joseph Saint Luc de Lyon
  • Provider of Information About this Clinical Study
    • Sponsor

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