NCT02551406

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

3 months

First QC Date

September 15, 2015

Last Update Submit

February 25, 2016

Conditions

Home Mechanical VentilationNeuromuscular Disease

Keywords

nocturnal hypoventilationcapno-oxymetry

Outcome Measures

Primary Outcomes (1)

  • Time to first ICU admission

    Time to first ICU admission

    6 years

Secondary Outcomes (1)

  • Mortality

    6 years

Interventions

Capno-oxymetry monitoringDEVICE

Monitoring of home mechanical ventilation by capno-oximetry

Eligibility Criteria

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

Ventilated neuromuscular disease patients followed at the Franch national reference center of Garches.

You may qualify if:

  • neuromuscular disease
  • age ≥18 years
  • mechanically ventilated
  • capno-oxymetry performed between 2009 and 2011

You may not qualify if:

  • Long-term oxygen therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Raymond Poincare

Garches, Garches, 92380, France

Location

Related Publications (1)

  • Ogna A, Nardi J, Prigent H, Quera Salva MA, Chaffaut C, Lamothe L, Chevret S, Annane D, Orlikowski D, Lofaso F. Prognostic Value of Initial Assessment of Residual Hypoventilation Using Nocturnal Capnography in Mechanically Ventilated Neuromuscular Patients: A 5-Year Follow-up Study. Front Med (Lausanne). 2016 Sep 13;3:40. doi: 10.3389/fmed.2016.00040. eCollection 2016.

    PMID: 27679799DERIVED

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Design

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

Study Record Dates

First Submitted

September 15, 2015

First Posted

September 16, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 26, 2016

Record last verified: 2016-02

Locations

FR(1)