NCT01449331CompletedNot Applicable
Qualitative Outcomes After Palliative Noninvasive Mechanical Ventilation : OVNI Study
Assistance Publique - Hôpitaux de Paris1 site in 1 country1,450 target enrollmentStarted: November 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,450
- Locations
- 1
- Primary Endpoint
- Quality of life of patients receiving palliative noninvasive mechanical ventilation
Study Overview
Brief Summary
The purpose of this study is:
- to estimate the frequency of the use of non invasive ventilation
- to estimate the frequency of the use of palliative non invasive ventilation
- to evaluate the impact of non invasive ventilation
- to propose some recommendations
Detailed Description
The purpose of this study is:
- to estimate the frequency of the use of non invasive ventilation
- to estimate the frequency of the use of palliative non invasive ventilation
- to evaluate the impact
- to propose some recommendations
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Acute respiratory failure
- •hospitalization in ICU
- •age >= 18 years
Exclusion Criteria
- •Patients who have already participated to OVNI
Outcomes
Primary Outcomes
Quality of life of patients receiving palliative noninvasive mechanical ventilation
Time Frame: day 90
Quality of life, assessed by short-form (SF)-36 health survey at day 90 after ICU discharge (average expected duration=7 days)
Secondary Outcomes
- Anxiety and Depression (evaluated by HADS)(day 90)
- Survival status(patients will be followed during an average time of 14 days (mean hospitalization time) and until day 90 after ICU discharge)
- Post traumatic stress disorder, evaluated by Impact of Event Scale(IES) questionnaire(day 90)
Investigators
Study Sites (1)
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