Respiratory Care in Intensive Care Unit for Neuromuscular Patients

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02936908
• Other study ID #: 69HCL16_0558
• Status: Recruiting
• Phase: N/A
• First received: August 19, 2016
• Last updated: August 28, 2017
• Start date: August 2016
• Est. completion date: October 2017

Study information

• Verified date: August 2017
• Source: Hospices Civils de Lyon
• Contact: Paul Chabert
• Phone: 4 26 10 94 18
• Email: polchaber[@]yahoo.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

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)

Locations

Country	Name	City	State
France	CHU Clermont Ferrand	Clermont Ferrand
France	CHU Grenoble	Grenoble
France	Hôpital de la Croix Rousse	Lyon
France	Hôpital Nord CHU St Etienne	St Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	number of death	until 2016.12.31
Secondary	Definitive long term invasive ventilatory support	Date of tracheotomy for definitive long term invasive ventilatory support	until 2016.12.31
Secondary	Mortality attributable to a respiratory issue	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
Secondary	Re-hospitalization in a ICU-Ward	clinical deterioration requiring a new hospitalization in a ICU ward, after first hospitalization discharge.	until 2016.12.31