NCT03090126

Brief Summary

The purpose of the study is to assess the therapeutic education of patients with chronic respiratory failure who start to be treated with non invasive ventilation and during the first six months of ventilation.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

March 15, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

March 17, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

3.5 years

First QC Date

March 15, 2017

Last Update Submit

July 13, 2020

Conditions

Alveolar Hypoventilation

Outcome Measures

Primary Outcomes (1)

  • Score efficacy of therapeutic education

    calculation of the global mean score of the questionnaire dedicated to the knowledge about the ventilation device

    6 months

Secondary Outcomes (2)

  • Compliance with the non invasive ventilation

    6 months

  • Dyspnea score

    6 months

Study Arms (1)

Alveolar hypoventilation

Other: Therapeutic education

Interventions

Therapeutic educationOTHER

Questionnaires

Alveolar hypoventilation

Eligibility Criteria

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

Patients

You may qualify if:

  • Patients with chronic respiratory failure
  • with alveolar hypoventilation required non invasive ventilation
  • Adults and non-vulnerable subject
  • Fluency in French

You may not qualify if:

  • Age under eighteen years old
  • Patient with guardianship
  • No french-speaking
  • Severe cognitive abnormalities
  • No criteria to introduce non invasive ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INSERM-UPC UMR_S 1158 Service de Pneumologie et Réanimation, R3S, Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Hypoventilation

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

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

Study Record Dates

First Submitted

March 15, 2017

First Posted

March 24, 2017

Study Start

March 17, 2017

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations

FR(1)