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

Completed

• Conditions: Acute Respiratory Failure

• Registration Number: NCT01449331
• Lead Sponsor: 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

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 Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-10-05
• Study First Submitted QC: 2011-10-07
• Study First Posted: 2011-10-10
• Status Verified: 2012-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2016-04-15
• Last Update Posted: 2016-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1450

Inclusion Criteria

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

Exclusion Criteria

• Patients who have already participated to OVNI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life of patients receiving palliative noninvasive mechanical ventilation	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

Name	Time	Method
Anxiety and Depression (evaluated by HADS)	day 90	Anxiety and depression at day 90 after ICU discharge (expected average duration=7 days), evaluated by Hospital Anxiety Depression Scale
Survival status	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
Post traumatic stress disorder, evaluated by Impact of Event Scale(IES) questionnaire	day 90	PTSD evaluated by the Impact of Event Scale at day 90 after ICU discharge (average expected duration=7 days)

Trial Locations

Locations (1)

Hôpital Saint-Louis, AP-HP; 🇫🇷 Paris, France