Clinical trial NCT01449331: The Use of Palliative Non Invasive Ventilation in Acute Respiratory Failure. OVNI Study.
Official title: Qualitative Outcomes After Palliative Noninvasive Mechanical Ventilation : OVNI Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Failure
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2011-10-10
Enrollment: 1450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with non invasive ventilation in ICU

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

Eligibility criteria: Inclusion Criteria:

* Acute respiratory failure
* hospitalization in ICU
* age \>= 18 years

Exclusion Criteria:

* Patients who have already participated to OVNI

Primary outcomes:
measure: Quality of life of patients receiving palliative noninvasive mechanical ventilation
timeFrame: day 90
Secondary outcomes:
measure: Anxiety and Depression (evaluated by HADS)
timeFrame: day 90
measure: Survival status
timeFrame: patients will be followed during an average time of 14 days (mean hospitalization time) and until day 90 after ICU discharge
measure: Post traumatic stress disorder, evaluated by Impact of Event Scale(IES) questionnaire
timeFrame: day 90
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint-Louis, AP-HP
Study officials:
affiliation: Service de Réanimation Médicale, Hôpital Saint Louis, AP-HP, France
name: Elie Azoulay, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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, Guerin C, Georges H, Zuber B, Dellamonica J, Das V, Cousson J, Perez D, Brochard L, Azoulay E; oVNI Study Group; REVA Network (Research Network in Mechanical Ventilation). Changing use of noninvasive ventilation in critically ill patients: trends over 15 years in francophone countries. Intensive Care Med. 2016 Jan;42(1):82-92. doi: 10.1007/s00134-015-4087-4. Epub 2015 Oct 13.
citation: 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, Touati S, Kilani S, Alves M, Mercat A, Similowski T, Papazian L, Meert AP, Chevret S, Schlemmer B, Brochard L, Demoule A. Noninvasive mechanical ventilation in patients having declined tracheal intubation. Intensive Care Med. 2013 Feb;39(2):292-301. doi: 10.1007/s00134-012-2746-2. Epub 2012 Nov 27.
citation: Dangers L, Montlahuc C, Kouatchet A, Jaber S, Meziani F, Perbet S, Similowski T, Resche-Rigon M, Azoulay E, Demoule A; REVA Network (Research Network in Mechanical Ventilation) and the Groupe de Recherche en Reanimation Respiratoire en Onco-Hematologie (GrrrOH); List of contributors who included study patients: Angers University Hospital, Angers, France:. Dyspnoea in patients receiving noninvasive ventilation for acute respiratory failure: prevalence, risk factors and prognostic impact: A prospective observational study. Eur Respir J. 2018 Aug 9;52(2):1702637. doi: 10.1183/13993003.02637-2017. Print 2018 Aug.