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Clinical Trials/NCT02766946
NCT02766946
Completed
Not Applicable

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

Centre Hospitalier Saint Joseph Saint Luc de Lyon0 sites97 target enrollmentJune 24, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Septic Shock
Sponsor
Centre Hospitalier Saint Joseph Saint Luc de Lyon
Enrollment
97
Primary Endpoint
Change from day 1 diaphragm thickness at day 3 and day 5
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 24, 2013
End Date
December 22, 2015
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre Hospitalier Saint Joseph Saint Luc de Lyon
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

  • Diaphragm thickness measured by ultrasound(10 days after introduction of Mechanical Ventilation)
  • Type of ventilatory support(10 days after start of ventilatory support)
  • Ventilatory mode(10 days after start of ventilatory support)
  • Diaphragmatic strength(intraoperative)
  • MRC score (Medical Research Council)(intraoperative)
  • Respiratory rate(10 days after start of ventilatory support)
  • Highest inspiratory pressure level(10 days after start of ventilatory support)
  • Pectoralis muscle thickness measured by ultrasound(10 days after start of ventilatory support)
  • Early or late extubation failure rate (extubation performed before or after 48 hours)(The last day of hospitalisation)
  • Length of ventilation in hours(10 days after start of ventilatory support)
  • Drug administration(10 days after start of ventilatory support)
  • Total positive end expiratory pressure(10 days after start of ventilatory support)
  • Highest expiratory pressure level(10 days after start of ventilatory support)
  • External positive end expiratory pressure(10 days after start of ventilatory support)
  • Volume of exhaled air(10 days after start of ventilatory support)

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