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

Acute Respiratory Failure Clinical Trial

— OVNI  

Official title:

Qualitative Outcomes After Palliative Noninvasive Mechanical Ventilation : OVNI Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449331
• Other study ID #: AOM 09006
• Status: Completed
• Phase: N/A
• First received: October 5, 2011
• Last updated: April 15, 2016
• Start date: November 2010
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1450
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acute respiratory failure

• hospitalization in ICU

• age >= 18 years

Exclusion Criteria:

• Patients who have already participated to OVNI

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Locations

Country	Name	City	State
France	Hôpital Saint-Louis, AP-HP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (2)

Azoulay E, Kouatchet A, Jaber S, Lambert J, Meziani F, Schmidt M, Schnell D, Mortaza S, Conseil M, Tchenio X, Herbecq P, Andrivet P, Guerot E, Lafabrie A, Perbet S, Camous L, Janssen-Langenstein R, Collet F, Messika J, Legriel S, Fabre X, Guisset O, Touat — View Citation

Demoule A, Chevret S, Carlucci A, Kouatchet A, Jaber S, Meziani F, Schmidt M, Schnell D, Clergue C, Aboab J, Rabbat A, Eon B, Guérin C, Georges H, Zuber B, Dellamonica J, Das V, Cousson J, Perez D, Brochard L, Azoulay E; oVNI Study Group; REVA Network (Re — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life of patients receiving palliative noninvasive mechanical ventilation	Quality of life, assessed by short-form (SF)-36 health survey at day 90 after ICU discharge (average expected duration=7 days)	day 90	No
Secondary	Anxiety and Depression (evaluated by HADS)	Anxiety and depression at day 90 after ICU discharge (expected average duration=7 days), evaluated by Hospital Anxiety Depression Scale	day 90	No
Secondary	Survival status	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	No
Secondary	Post traumatic stress disorder, evaluated by Impact of Event Scale(IES) questionnaire	PTSD evaluated by the Impact of Event Scale at day 90 after ICU discharge (average expected duration=7 days)	day 90	No