Alveolar HypoventilationQoVNINCT03090126
Assessment of Therapeutic Education About Non Invasive Ventilation in Patients With Chronic Respiratory Failure (QoVNI)
An observational study of Alveolar Hypoventilation, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Hypoventilation
- What is being tested?
- Therapeutic education
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 17 Mar 2017to Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients
Who may be able to join
- Patients with chronic respiratory failure
- with alveolar hypoventilation required non invasive ventilation
- Adults and non-vulnerable subject
- Fluency in French
Who cannot join
- Age under eighteen years old
- Patient with guardianship
- No french-speaking
- Severe cognitive abnormalities
- No criteria to introduce non invasive ventilation
Trial locations and contacts
1 site in 1 country.
France1 site
INSERM-UPC UMR_S 1158 Service de Pneumologie et Réanimation, R3S, Groupe Hospitalier Pitié-Salpêtrière
Paris, 75013
About this study
Official title: 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.
Read the 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.
- Conditions
- Alveolar Hypoventilation
- Being tested
- Therapeutic education
- Medical subject headings
- Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic educationOther
Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Alveolar hypoventilation | Not described Receives: Other: Therapeutic education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score efficacy of therapeutic education
calculation of the global mean score of the questionnaire dedicated to the knowledge about the ventilation device
Measured: 6 months
Secondary outcomes (2)
Compliance with the non invasive ventilation
number of hours of non invasive ventilation use per day
Measured: 6 months
Dyspnea score
Dyspnea severity scoring between 0 and ten
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start17 Mar 2017
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Why it stopped: No possibility to recruit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar HypoventilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090126
- Sponsor's protocol ID
- 2017-A00189-44
- Acronym
- QoVNI
- Status last verified
- Jul 2020
- First submitted
- 15 Mar 2017
- Last updated
- 14 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Therapeutic Education About Non Invasive Ventilation in Patients With Chronic Respiratory
- ClinicalTrials.gov ID
- NCT03090126
- Acronym / sponsor ID
- QoVNI / 2017-A00189-44
- Conditions
- Alveolar Hypoventilation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No possibility to recruit.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le SommeilUniversity, hospital or other
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alveolar hypoventilation | – | Other: Therapeutic education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients
Key inclusion criteria (4 listed)
- Patients with chronic respiratory failure
- with alveolar hypoventilation required non invasive ventilation
- Adults and non-vulnerable subject
- Fluency in French
Key exclusion criteria (5 listed)
- Age under eighteen years old
- Patient with guardianship
- No french-speaking
- Severe cognitive abnormalities
- No criteria to introduce non invasive ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic educationQuestionnaires | Other | Alveolar hypoventilation |
Primary outcome
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
2 secondary outcomes
Compliance with the non invasive ventilation
Time frame: 6 months
Dyspnea score
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alveolar Hypoventilation, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score efficacy of therapeutic education (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.