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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01449331
First received: October 5, 2011
Last updated: November 19, 2012
Last verified: November 2012
History of Changes
  Purpose

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
Acute Respiratory Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Qualitative Outcomes After Palliative Noninvasive Mechanical Ventilation : OVNI Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Quality of life of patients receiving palliative noninvasive mechanical ventilation [ Time Frame: day 90 ] [ Designated as safety issue: No ]
    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:
  • Anxiety and Depression (evaluated by HADS) [ Time Frame: day 90 ] [ Designated as safety issue: No ]
    Anxiety and depression at day 90 after ICU discharge (expected average duration=7 days), evaluated by Hospital Anxiety Depression Scale

  • 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 ] [ Designated as safety issue: No ]
    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

  • Post traumatic stress disorder, evaluated by Impact of Event Scale(IES) questionnaire [ Time Frame: day 90 ] [ Designated as safety issue: No ]
    PTSD evaluated by the Impact of Event Scale at day 90 after ICU discharge (average expected duration=7 days)


Enrollment: 1450
Study Start Date: November 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01449331     History of Changes
Other Study ID Numbers: AOM 09006
Study First Received: October 5, 2011
Last Updated: November 19, 2012
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on May 19, 2013