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The Use of Palliative Non Invasive Ventilation in Acute Respiratory Failure. OVNI Study. (OVNI)

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ClinicalTrials.gov Identifier: NCT01449331
Recruitment Status : Completed
First Posted : October 10, 2011
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease
Acute Respiratory Failure

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 Type : Observational
Actual Enrollment : 1450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Qualitative Outcomes After Palliative Noninvasive Mechanical Ventilation : OVNI Study
Study Start Date : November 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Anxiety and Depression (evaluated by HADS) [ Time Frame: day 90 ]
    Anxiety and depression at day 90 after ICU discharge (expected average duration=7 days), evaluated by Hospital Anxiety Depression Scale

  2. Survival status [ Time Frame: patients will be followed during an average time of 14 days (mean hospitalization time) and until day 90 after ICU discharge ]
    Survival status (0=alive, 1=deceased)at ICU discharge (average expected duration=7 days)and hospital discharge (average expected duration=14 days), day 90 after ICU discharge, day 180 after ICU discharge and 1 year after ICU discharge

  3. Post traumatic stress disorder, evaluated by Impact of Event Scale(IES) questionnaire [ Time Frame: day 90 ]
    PTSD evaluated by the Impact of Event Scale at day 90 after ICU discharge (average expected duration=7 days)



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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:   Probability Sample
Study Population
Patients with non invasive ventilation in ICU
Criteria

Inclusion Criteria:

  • Acute respiratory failure
  • hospitalization in ICU
  • age >= 18 years

Exclusion Criteria:

  • Patients who have already participated to OVNI

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): NCT01449331


Locations
France
Hôpital Saint-Louis, AP-HP
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Elie Azoulay, MD,PhD Service de Réanimation Médicale, Hôpital Saint Louis, AP-HP, France

Publications of Results:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01449331     History of Changes
Other Study ID Numbers: AOM 09006
First Posted: October 10, 2011    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: November 2012

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases