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Completed

NCT Number: NCT01449331

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

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Key information

Conditions

Acute Respiratory Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Saint-Louis, AP-HP

Paris, 75010, France

About this 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
  • to propose some recommendations

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients who have already participated to OVNI

Treatment and study plan

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Qualitative Outcomes After Palliative Noninvasive Mechanical Ventilation : OVNI Study

Acronym: OVNI

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 10, 2011
Registry last updated
Apr 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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