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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014