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

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ClinicalTrials.gov Identifier: NCT03090126
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Alveolar Hypoventilation 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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Therapeutic Education About Non Invasive Ventilation in Patients With Chronic Respiratory
Actual Study Start Date : March 17, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Group/Cohort Intervention/treatment
Alveolar hypoventilation Other: Therapeutic education
Questionnaires




Primary Outcome Measures :
  1. Score efficacy of therapeutic education [ Time Frame: 6 months ]
    calculation of the global mean score of the questionnaire dedicated to the knowledge about the ventilation device


Secondary Outcome Measures :
  1. Compliance with the non invasive ventilation [ Time Frame: 6 months ]
    number of hours of non invasive ventilation use per day

  2. Dyspnea score [ Time Frame: 6 months ]
    Dyspnea severity scoring between 0 and ten



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090126


Locations
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France
INSERM-UPC UMR_S 1158 Service de Pneumologie et Réanimation, R3S, Groupe Hospitalier Pitié-Salpêtrière Recruiting
Paris, France, 75013
Contact: Ségolène Rémy-Neris    0142178196 ext 0033    segolene.remyneris@gmail.com   
Contact: Sophie Lavault, PhD    0142178196 ext 0033    sophie.lavault@aphp.fr   
Principal Investigator: Capucine Morelot-Panzini, MD, PhD         
Sponsors and Collaborators
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

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Responsible Party: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
ClinicalTrials.gov Identifier: NCT03090126     History of Changes
Other Study ID Numbers: 2017-A00189-44
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypoventilation
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms