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

April 15, 2016 updated by: Assistance Publique - Hôpitaux de Paris

Qualitative Outcomes After Palliative Noninvasive Mechanical Ventilation : OVNI Study

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

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

1450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Hôpital Saint-Louis, AP-HP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with non invasive ventilation in ICU

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who have already participated to OVNI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 90
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
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
Time Frame: day 90
PTSD evaluated by the Impact of Event Scale at day 90 after ICU discharge (average expected duration=7 days)
day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Elie Azoulay, MD,PhD, Service de Réanimation Médicale, Hôpital Saint Louis, AP-HP, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

October 5, 2011

First Submitted That Met QC Criteria

October 7, 2011

First Posted (Estimate)

October 10, 2011

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOM 09006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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