Assessment of Therapeutic Education About Non Invasive Ventilation in Patients With Chronic Respiratory Failure (QoVNI)

Alveolar Hypoventilation Clinical Trial

— QoVNI  

Official title:

Assessment of Therapeutic Education About Non Invasive Ventilation in Patients With Chronic Respiratory

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03090126
• Other study ID #: 2017-A00189-44
• Status: Withdrawn
• Start date: March 17, 2017
• Est. completion date: October 2020

Study information

• Verified date: July 2020
• Source: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Therapeutic education about non invasive ventilation in patients with chronic respiratory failure and alveolar hypoventilation is assessed during the first six months of ventilation thanks to a questionnaire. Moreover, the impact of this therapeutic education on non invasive ventilation compliance, blood gas, dyspnea and nocturnal desaturation is assessed.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with chronic respiratory failure

• with alveolar hypoventilation required non invasive ventilation

• Adults and non-vulnerable subject

• Fluency in French

Exclusion Criteria:

• Age under eighteen years old

• Patient with guardianship

• No french-speaking

• Severe cognitive abnormalities

• No criteria to introduce non invasive ventilation

Related Conditions & MeSH terms

• Alveolar Hypoventilation
• Hypoventilation

Intervention

Other:
• Therapeutic education
Questionnaires

Locations

Country	Name	City	State
France	INSERM-UPC UMR_S 1158 Service de Pneumologie et Réanimation, R3S, Groupe Hospitalier Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compliance with the non invasive ventilation	number of hours of non invasive ventilation use per day	6 months
Secondary	Dyspnea score	Dyspnea severity scoring between 0 and ten	6 months