NCT02936908

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

1.2 years

First QC Date

August 19, 2016

Last Update Submit

August 28, 2017

Conditions

Respiratory Failure

Keywords

Neuromuscular DiseasesMuscular dystrophyAmyotrophic Lateral SclerosisAcute respiratory failurerespiratory caremechanical ventilationweaningIntensive Care UnitCritical CareSurvival

Outcome Measures

Primary Outcomes (1)

  • Mortality

    number of death

    until 2016.12.31

Secondary Outcomes (3)

  • Definitive long term invasive ventilatory support

    until 2016.12.31

  • Mortality attributable to a respiratory issue

    until 2016.12.31

  • Re-hospitalization in a ICU-Ward

    until 2016.12.31

Study Arms (1)

Ventilatory support

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

Other: Ventilatory support

Interventions

Ventilatory supportOTHER

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)

Ventilatory support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Patient \> 18 years old
  • First stay in a ICU ward
  • Presenting an acute respiratory distress at admission or during ICU stay
  • Diagnosis of neuromuscular disease confirmed before Hospital discharge

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU Clermont Ferrand

Clermont-Ferrand, France

RECRUITING

CHU Grenoble

Grenoble, France

RECRUITING

Hôpital de la Croix Rousse

Lyon, France

RECRUITING

Hôpital Nord CHU St Etienne

Saint-Etienne, France

RECRUITING

MeSH Terms

Conditions

Respiratory InsufficiencyNeuromuscular DiseasesMuscular DystrophiesAmyotrophic Lateral Sclerosis

Interventions

Interactive Ventilatory Support

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesNervous System DiseasesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSpinal Cord DiseasesCentral Nervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Central Study Contacts

Paul Chabert

CONTACT

4 26 10 94 18polchaber@yahoo.fr

Claude Guerin, PU-PH

CONTACT

4 26 10 94 18

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2016

First Posted

October 18, 2016

Study Start

August 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

August 29, 2017

Record last verified: 2017-08

Locations

FR(4)