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NCT Number: NCT02766946

Diaphragmatic Atrophy Related to Mechanical Ventilation

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.

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Key information

Conditions

Septic Shock Acute Lung Injury Acute Respiratory Distress Infections Inflammation Lung Diseases Lung Injury Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Device

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

Neuromyopathy score

Other

A neuromyopathy score will be assessed on the extubation day

Respiratory performances

Other

An assessment of the respiratory performances will be done on the extubation day, including higher expiratory pressure, higher inspiratory pressure, and occlusion pressure

Primary outcomes

  1. 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 outcomes

  1. Diaphragm thickness measured by ultrasound

    Time frame: 10 days after introduction of Mechanical Ventilation

  2. 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)

  3. Ventilatory mode

    Time frame: 10 days after start of ventilatory support

    Ventilatory mode (controlled ventilation, pressure support ventilation)

  4. 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

  5. Diaphragmatic strength

    Time frame: intraoperative

    Relation between diaphragmatic atrophy and decrease of diaphragmatic strength

  6. 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

  7. MRC score (Medical Research Council)

    Time frame: intraoperative

    Relation between diaphragmatic atrophy and decrease of diaphragmatic strength

  8. Length of ventilation in hours

    Time frame: 10 days after start of ventilatory support

  9. 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

  10. Total positive end expiratory pressure

    Time frame: 10 days after start of ventilatory support

  11. External positive end expiratory pressure

    Time frame: 10 days after start of ventilatory support

  12. Respiratory rate

    Time frame: 10 days after start of ventilatory support

  13. Highest inspiratory pressure level

    Time frame: 10 days after start of ventilatory support

  14. Highest expiratory pressure level

    Time frame: 10 days after start of ventilatory support

  15. Volume of exhaled air

    Time frame: 10 days after start of ventilatory support

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Other

Registry information

Official study title

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

Acronym: ECHODIAPH

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 10, 2016
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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