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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Alveolar Hypoventilation
• Intervention / Treatment: Other: Therapeutic education

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 Type: Observational

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • INSERM-UPC UMR_S 1158 Service de Pneumologie et Réanimation, R3S, Groupe Hospitalier Pitié-Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Alveolar hypoventilation	Other: Therapeutic education; Questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance with the non invasive ventilation	number of hours of non invasive ventilation use per day	6 months
Dyspnea score	Dyspnea severity scoring between 0 and ten	6 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2017
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: March 15, 2017
• First Submitted That Met QC Criteria: March 20, 2017
• First Posted (Actual): March 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypoventilation
• Other Study ID Numbers: 2017-A00189-44

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No