Acute Respiratory FailureOVNINCT01449331
The Use of Palliative Non Invasive Ventilation in Acute Respiratory Failure. OVNI Study.
An observational study of Acute Respiratory Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- How many people
- 1,450 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with non invasive ventilation in ICU
Who may be able to join
- Acute respiratory failure
- hospitalization in ICU
- age >= 18 years
Who cannot join
- Patients who have already participated to OVNI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Qualitative Outcomes After Palliative Noninvasive Mechanical Ventilation : 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
Read the 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
- Conditions
- Acute Respiratory Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: day 90
Secondary outcomes (3)
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
Measured: day 90
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
Measured: 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
PTSD evaluated by the Impact of Event Scale at day 90 after ICU discharge (average expected duration=7 days)
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startNov 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elie Azoulay, MD,PhD, Principal investigator, Service de Réanimation Médicale, Hôpital Saint Louis, AP-HP, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449331
- Sponsor's protocol ID
- AOM 09006
- Acronym
- OVNI
- Status last verified
- Nov 2012
- First submitted
- 5 Oct 2011
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26464393Azoulay 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.
PubMed 23184037Dangers 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.
PubMed 29976650
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Outcomes After Palliative Noninvasive Mechanical Ventilation : OVNI Study
- ClinicalTrials.gov ID
- NCT01449331
- Acronym / sponsor ID
- OVNI / AOM 09006
- Conditions
- Acute Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,450 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non invasive ventilation in ICU
Key inclusion criteria (3 listed)
- Acute respiratory failure
- hospitalization in ICU
- age >= 18 years
Key exclusion criteria (1 listed)
- Patients who have already participated to OVNI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
3 secondary outcomes
Anxiety and Depression (evaluated by HADS)
Time frame: day 90
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
Post traumatic stress disorder, evaluated by Impact of Event Scale(IES) questionnaire
Time frame: day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
- Results publication: PubMed 26464393Demoule 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.
- Results publication: PubMed 23184037Azoulay 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.
- Derived from this study: PubMed 29976650Dangers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elie Azoulay, MD,PhD principal investigator
Service de Réanimation Médicale, Hôpital Saint Louis, AP-HP, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life of patients receiving palliative noninvasive mechanical ventilation (time frame: day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01449331, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2016.