Respiratory Care in Intensive Care Unit for Neuromuscular Patients

August 28, 2017 updated by: Hospices Civils de Lyon

Modalities of Respiratory Care, Vital and Respiratory Prognosis in Neuromuscular Patients Admitted to an Intensive Care Unit for Respiratory Failure

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont Ferrand, France
        • Recruiting
        • Chu Clermont Ferrand
      • Grenoble, France
        • Recruiting
        • CHU Grenoble
      • Lyon, France
        • Recruiting
        • Hôpital de La Croix Rousse
        • Contact:
      • St Etienne, France
        • Recruiting
        • Hôpital Nord CHU St Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: until 2016.12.31
number of death
until 2016.12.31

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Definitive long term invasive ventilatory support
Time Frame: until 2016.12.31
Date of tracheotomy for definitive long term invasive ventilatory support
until 2016.12.31
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.
until 2016.12.31
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.
until 2016.12.31

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

August 19, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0558

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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