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

Withdrawn

• Conditions: Alveolar Hypoventilation

• Registration Number: NCT03090126
• Lead Sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-03-15
• Study Start: 2017-03-17
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-24
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-14
• Primary Completion: 2020-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Score efficacy of therapeutic education	6 months	calculation of the global mean score of the questionnaire dedicated to the knowledge about the ventilation device

Secondary Outcome Measures

Name	Time	Method
Compliance with the non invasive ventilation	6 months	number of hours of non invasive ventilation use per day
Dyspnea score	6 months	Dyspnea severity scoring between 0 and ten

Trial Locations

Locations (1)

INSERM-UPC UMR_S 1158 Service de Pneumologie et Réanimation, R3S, Groupe Hospitalier Pitié-Salpêtrière; 🇫🇷 Paris, France