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Clinical Trials/NCT01449331
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

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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