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NCT02551406 Clinical Trial

Prognostic Value of Residual Hypoventilation in Mechanically Ventilated Neuromuscular Patients

Neuromuscular Disease Clinical Trial

— TcCO2-VAD  

Official title:
Prognostic Value of Residual Hypoventilation in Mechanically Ventilated Neuromuscular Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02551406
Other study ID # TcCO2-VAD
Secondary ID
Status Completed
Phase N/A
First received September 15, 2015
Last updated February 25, 2016
Start date September 2015
Est. completion date December 2015

Study information
Verified date February 2016
Source Centre d'Investigation Clinique et Technologique 805
Contact n/a
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial Summary

Different tools may be used to monitor the efficacy of home mechanical ventilation. Investigators aimed to compare the prognostic value of the different data obtained by capno-oxymetry in a mechanical ventilated neuromuscular disease's population.

Description:

Home mechanical ventilation (HMV) is used to treat hypoventilation, and its efficacy is mostly assessed by daytime blood gases and nocturnal oxymetry (SpO2). Transcutaneous CO2 measure (TcCO2) has shown higher sensitivity than SpO2 to detect hypoventilation in neuromuscular diseases (NMD) patients. No data exist on the prognostic value of these techniques to monitor mechanical ventilated NMD patients.

Basing on retrospective data review, investigators aimed to compare the prognostic value of the data obtained using different tools to assess residual hypoventilation in the cohort of ventilated NMD patients followed at our reference center.

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- neuromuscular disease

- age =18 years

- mechanically ventilated

- capno-oxymetry performed between 2009 and 2011

Exclusion Criteria:

- Long-term oxygen therapy

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Device:
• Capno-oxymetry monitoring
Monitoring of home mechanical ventilation by capno-oximetry

Locations
Country Name City State
France Hopital Raymond Poincare Garches

Sponsors (1)
Lead Sponsor Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to first ICU admission Time to first ICU admission 6 years No
Secondary Mortality Time to death 6 years No
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