Respiratory Care in Intensive Care Unit for Neuromuscular Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02936908
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : August 29, 2017
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Retrospective multicentric observational study exploring the population of adult neuromuscular patients presenting a respiratory distress requiring their admission in an Intensive Care Unit (ICU) for ventilatory support.

Research of markers associated with long term mortality and ventilatory status.

Condition or disease Intervention/treatment
Respiratory Failure Other: Ventilatory support

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Modalities of Respiratory Care, Vital and Respiratory Prognosis in Neuromuscular Patients Admitted to an Intensive Care Unit for Respiratory Failure
Study Start Date : August 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Group/Cohort Intervention/treatment
Ventilatory support
Adult patients presenting a neuromuscular disease, with involvement of respiratory or bulbar muscles
Other: Ventilatory support
Initiation of mechanical ventilatory support, invasive or non-invasive, Or modification of mechanical ventilatory support (modification of the parameters of the device, change of material, switch from non-invasive to invasive)

Primary Outcome Measures :
  1. Mortality [ Time Frame: until 2016.12.31 ]
    number of death

Secondary Outcome Measures :
  1. Definitive long term invasive ventilatory support [ Time Frame: until 2016.12.31 ]
    Date of tracheotomy for definitive long term invasive ventilatory support

  2. Mortality attributable to a respiratory issue [ Time Frame: until 2016.12.31 ]
    For patients for which this information is available, cause of death described as reliable to a respiratory issue in any medical document available.

  3. Re-hospitalization in a ICU-Ward [ Time Frame: until 2016.12.31 ]
    clinical deterioration requiring a new hospitalization in a ICU ward, after first hospitalization discharge.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients presenting a neuromuscular disease, with involvement of respiratory or bulbar muscles.

Neuromuscular diseases concerned :

Central or Peripheral metabolic, toxic, or inflammatory neuropathies, Central or peripheral neurodegenerative or hereditary disorders Myopathies, amongst them dystrophinopathies, myotonic dystrophies Myasthenia gravis Tetraplegy, consequence of cervical spinal cord injury


Inclusion Criteria:

  • Patient > 18 years old
  • First stay in a ICU ward
  • Inclusion period : Admission in ICU between 01/01/2007 and 31/12/2015
  • Presenting an acute respiratory distress at admission or during ICU stay
  • Diagnosis of neuromuscular disease confirmed before Hospital discharge

Exclusion Criteria:

  • Absence of respiratory failure during ICU stay (ICU stay for monitoring or for a specialized invasive procedure in the absence of respiratory failure, for example)
  • Neuromuscular disease not proven or uncertain diagnosis
  • Anterior admission in ICU ward for vital organ failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02936908

Contact: Paul Chabert 4 26 10 94 18 ext +33
Contact: Claude Guerin, PU-PH 4 26 10 94 18 ext +33

CHU Clermont Ferrand Recruiting
Clermont Ferrand, France
CHU Grenoble Recruiting
Grenoble, France
Hôpital de la Croix Rousse Recruiting
Lyon, France
Contact: Claude Guerin    4 26 10 94 18 ext +33   
Hôpital Nord CHU St Etienne Recruiting
St Etienne, France
Sponsors and Collaborators
Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon Identifier: NCT02936908     History of Changes
Other Study ID Numbers: 69HCL16_0558
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017

Keywords provided by Hospices Civils de Lyon:
Neuromuscular Diseases
Muscular dystrophy
Amyotrophic Lateral Sclerosis
Acute respiratory failure
respiratory care
mechanical ventilation
Intensive Care Unit
Critical Care

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases