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

NCT01449331 | Completed

• 1 other identifier: AOM 09006
• Study Type: observational
• Target: 1,450
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Anxiety and Depression (evaluated by HADS)

  day 90

• Survival status

  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

  day 90

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with non invasive ventilation in ICU

You may qualify if:

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

You may not qualify if:

• Patients who have already participated to OVNI

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Saint-Louis, AP-HP

Paris, 75010, France

Location

Related Publications (3)

• 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.

  PMID: 26464393 RESULT

• 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.

  PMID: 23184037 RESULT

• 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.

  PMID: 29976650 DERIVED

Study Officials

• Elie Azoulay, MD,PhD

  Service de Réanimation Médicale, Hôpital Saint Louis, AP-HP, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2011
• First Posted: October 10, 2011
• Study Start: November 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 18, 2016

Record last verified: 2012-11

Locations

FR (1)