- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02936908
Respiratory Care in Intensive Care Unit for Neuromuscular Patients
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.
Studieoversigt
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
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Clermont Ferrand, Frankrig
- Rekruttering
- Chu Clermont Ferrand
-
Grenoble, Frankrig
- Rekruttering
- Chu Grenoble
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Lyon, Frankrig
- Rekruttering
- Hôpital de La Croix Rousse
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Kontakt:
- Claude Guerin
- Telefonnummer: +33 4 26 10 94 18
- E-mail: claude.guerin@chu-lyon.fr
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St Etienne, Frankrig
- Rekruttering
- Hôpital Nord CHU St Etienne
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Tilbagevirkende kraft
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Ventilatory support
Adult patients presenting a neuromuscular disease, with involvement of respiratory or bulbar muscles
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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)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mortality
Tidsramme: until 2016.12.31
|
number of death
|
until 2016.12.31
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Definitive long term invasive ventilatory support
Tidsramme: until 2016.12.31
|
Date of tracheotomy for definitive long term invasive ventilatory support
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until 2016.12.31
|
|
Mortality attributable to a respiratory issue
Tidsramme: 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.
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until 2016.12.31
|
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Re-hospitalization in a ICU-Ward
Tidsramme: until 2016.12.31
|
clinical deterioration requiring a new hospitalization in a ICU ward, after first hospitalization discharge.
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until 2016.12.31
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 69HCL16_0558
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