WithdrawalARREVENCT01818895
Terminal Weaning of Mechanical Ventilation or Extubation in Anticipation of Death in the Intensive Care Unit
An observational study of Withdrawal and Anxiety, run by Centre Hospitalier Departemental Vendee at 44 sites in France.
Trial summary
The purpose of the study is to assess the dying process in critically ill patients with decision to withdraw invasive mechanical ventilation in anticipation of death and to compare effects of extubation and those of terminal weaning of mechanical ventilation on relatives and care givers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Withdrawal, Anxiety, Depression
- How many people
- 458 participants
- Where
- 44 sitesFrance
- Study dates
- Apr 2013to May 2015
- 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 admitted in ICU with end of life decision to withdraw invasive mechanical ventilation after at least 48 hours of ICU stay
Who may be able to join
- End of life decision to withdraw invasive mechanical ventilation after at least 48 hours of ICU stay
Who cannot join
- Age under 18 years
- Non invasive mechanical ventilation
- Brain death
- Death before withdrawal of mechanical ventilation
- No French-speaking relative
- Refusal of relative to participate the study
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
France44 sites
Réanimation médicale CHU
Angers, 49000
Réanimation, CH d'Angoulême
Angoulême
Réanimation, CH d'Annecy
Annecy
Réanimation
Belfort
CHU Pellegrin Tripode
Bordeaux, 33076
Réanimation, CHU
Bordeaux
CHU Ambroise Paré
Boulogne
CHU La Cavale Blanche
Brest
CHU de Côte de Lumière
Caen
Centre Hospitalier, Service de réanimation
Charleville-Mézières
CH de Chartres
Chartres
CHU Gabriel Montpied, Clermont Ferrand
Clermont-Ferrand, 63003
CHU Louis Mourier
Colombes
CH de Dieppe
Dieppe, 76202
CHU Dijon
Dijon, 21079
CHU Raymond Poincaré
Garches, 92380
CHU Grenoble
Grenoble, 38043
CHD de la Vendée
La Roche-sur-Yon
CH de La Rochelle
La Rochelle
CH du Mans
Le Mans
CH du Puy
Le Puy-en-Velay
CH Docteur Schaffner
Lens, 62307
CHU de Lille
Lille
CH de Lorient
Lorient
CHU Marseille, Hopital La Timone
Marseille, 13000
CHU de Marseille, Hopital Nord
Marseille
CH Marc Jacquet
Melun, 77000
CH de Montauban
Montauban, 82013
CHI André Grégoire
Montreuil, 93105
CH de Mulhouse
Mulhouse
CHU de Nantes - Hôtel Dieu
Nantes, 44093
CHU Orléans - Réanimation Médicale
Orléans
CHU Saint Louis
Paris, 75010
CHU Paris Cochin
Paris, 75014
Groupe Hospitalier Paris Saint Joseph
Paris, 75014
CHU Hopital Européen Georges Pompidou
Paris
CHU Lariboisière
Paris
CHU Poitiers
Poitiers, 86021
CH de Roanne
Roanne
Hôpital Delafontaine
Saint-Denis, 93200
CH de Saint-Nazaire
Saint-Nazaire
Hôpital Foch
Suresnes, 92150
CHU Tours
Tours, 37044
Institut Gustave Roussy
Villejuif
About this study
Official title: Terminal Weaning of Mechanical Ventilation or Extubation in Anticipation of Death in the Intensive Care Unit: Impact on Relatives, Care Givers and the Dying Process - A Prospective, Multicenter, Observational Study
The purpose of the study is to assess the dying process in critically ill patients with decision to withdraw invasive mechanical ventilation in anticipation of death and to compare effects of extubation and those of terminal weaning of mechanical ventilation on relatives and care givers. The investigators primary hypothesis is that extubation is associated with less symptoms of post-traumatic stress disorders in relatives, as compared to terminal weaning.
- Conditions
- Withdrawal, Anxiety, Depression, Posttraumatic Stress Disorder
- Keywords
- Mechanical ventilation, End of life, Extubation, Terminal weaning, Complicated grief
- Medical subject headings
- Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Withdrawal of mechanical ventilation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post traumatic Stress Disorder
Post traumatic Stress Disorder as assessed by the Impact of event Scale-revised(IES-R)
Measured: three month after patient's death
Secondary outcomes (8)
Post traumatic Stress Disorder
Post traumatic stress disorder of relatives assessed by the Impact of Event Scale -revised (IES-R)
Measured: 12 months after patient's death
Anxiety and depression
Anxiety and depression of the relatives, assessed by the hospital Anxiety and Depression Scale (HADS)
Measured: 3, 6 and 12 months after patient's death
Complicated grief
Complicated grief as assessed by the Inventory of Complicated Grief (ICG) scale
Measured: 6 and 12 months after patient's death
Relative's satisfaction
Questionnaire on relative's satisfaction
Measured: 3 months after patient's death
Nurse's satisfaction
Questionnaire on nurse's satisfaction
Measured: within day 1 after patient's death
Physician's satisfaction
Questionnaire on physician's satisfaction
Measured: within day 1 after patient's death
Burn out syndrome of the nurse
Burn out syndrome of the patient's nurse as assessed by the Job Strain scale
Measured: within day 1 after patient's death
Burn out syndrome of the physician
Burn out syndrome of the patient's physician as assessed by the Job Strain scale
Measured: within day 1 after patient's death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WithdrawalStudies of the same condition, open and under way.
- 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
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Collaborators
- Poitiers University Hospital, Institut National de la Santé Et de la Recherche Médicale, France, University Hospital, Tours
- Responsible party
- Sponsor
- Investigators
- Jean Reignier, MD, PhD, Principal investigator, Centre Hospitalier Départemental de la Vendée, La Roche sur Yon, FranceRené Robert, MD, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818895
- Sponsor's protocol ID
- CHD 018-13
- Acronym
- ARREVE
- Status last verified
- Jul 2015
- First submitted
- 21 Mar 2013
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Robert R, Le Gouge A, Kentish-Barnes N, Cottereau A, Giraudeau B, Adda M, Annane D, Audibert J, Barbier F, Bardou P, Bourcier S, Bourenne J, Boyer A, Brenas F, Das V, Desachy A, Devaquet J, Feissel M, Ganster F, Garrouste-Orgeas M, Grillet G, Guisset O, Hamidfar-Roy R, Hyacinthe AC, Jochmans S, Jourdain M, Lautrette A, Lerolle N, Lesieur O, Lion F, Mateu P, Megarbane B, Merceron S, Mercier E, Messika J, Morin-Longuet P, Philippon-Jouve B, Quenot JP, Renault A, Repesse X, Rigaud JP, Robin S, Roquilly A, Seguin A, Thevenin D, Tirot P, Vinatier I, Azoulay E, Reignier J. Terminal weaning or immediate extubation for withdrawing mechanical ventilation in critically ill patients (the ARREVE observational study). Intensive Care Med. 2017 Dec;43(12):1793-1807. doi: 10.1007/s00134-017-4891-0. Epub 2017 Sep 22.
PubMed 28936597
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Terminal Weaning of Mechanical Ventilation or Extubation in Anticipation of Death in the Intensive Care Unit: Impact on Relatives, Care Givers and the Dying Process - A Prospective, Multicenter, Observational Study
- ClinicalTrials.gov ID
- NCT01818895
- Acronym / sponsor ID
- ARREVE / CHD 018-13
- Conditions
- Withdrawal, Anxiety, Depression, Posttraumatic Stress Disorder
- Keywords
- Mechanical ventilation, End of life, Extubation, Terminal weaning, Complicated grief
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Collaborators
- Poitiers University Hospital, Institut National de la Santé Et de la Recherche Médicale, France, University Hospital, Tours
- Study start
- Apr 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 27 Mar 2013 (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 the study is to assess the dying process in critically ill patients with decision to withdraw invasive mechanical ventilation in anticipation of death and to compare effects of extubation and those of terminal weaning of mechanical ventilation on relatives and care givers. The investigators primary hypothesis is that extubation is associated with less symptoms of post-traumatic stress disorders in relatives, as compared to terminal weaning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Withdrawal of mechanical ventilation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in ICU with end of life decision to withdraw invasive mechanical ventilation after at least 48 hours of ICU stay
Key inclusion criteria (1 listed)
- End of life decision to withdraw invasive mechanical ventilation after at least 48 hours of ICU stay
Key exclusion criteria (6 listed)
- Age under 18 years
- Non invasive mechanical ventilation
- Brain death
- Death before withdrawal of mechanical ventilation
- No French-speaking relative
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
Post traumatic Stress Disorder
Time frame: three month after patient's death
Post traumatic Stress Disorder as assessed by the Impact of event Scale-revised(IES-R)
8 secondary outcomes
Post traumatic Stress Disorder
Time frame: 12 months after patient's death
Anxiety and depression
Time frame: 3, 6 and 12 months after patient's death
Complicated grief
Time frame: 6 and 12 months after patient's death
Relative's satisfaction
Time frame: 3 months after patient's death
Nurse's satisfaction
Time frame: within day 1 after patient's death
Physician's satisfaction
Time frame: within day 1 after patient's death
Burn out syndrome of the nurse
Time frame: within day 1 after patient's death
Burn out syndrome of the physician
Time frame: within day 1 after patient's death
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 10 Jul 2015.
- Derived from this study: PubMed 28936597Robert R, Le Gouge A, Kentish-Barnes N, Cottereau A, Giraudeau B, Adda M, Annane D, Audibert J, Barbier F, Bardou P, Bourcier S, Bourenne J, Boyer A, Brenas F, Das V, Desachy A, Devaquet J, Feissel M, Ganster F, Garrouste-Orgeas M, Grillet G, Guisset O, Hamidfar-Roy R, Hyacinthe AC, Jochmans S, Jourdain M, Lautrette A, Lerolle N, Lesieur O, Lion F, Mateu P, Megarbane B, Merceron S, Mercier E, Messika J, Morin-Longuet P, Philippon-Jouve B, Quenot JP, Renault A, Repesse X, Rigaud JP, Robin S, Roquilly A, Seguin A, Thevenin D, Tirot P, Vinatier I, Azoulay E, Reignier J. Terminal weaning or immediate extubation for withdrawing mechanical ventilation in critically ill patients (the ARREVE observational study). Intensive Care Med. 2017 Dec;43(12):1793-1807. doi: 10.1007/s00134-017-4891-0. Epub 2017 Sep 22.
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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.
Jean Reignier, MD, PhD principal investigator
Centre Hospitalier Départemental de la Vendée, La Roche sur Yon, France
René Robert, MD principal investigator
Poitiers University Hospital
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Withdrawal and Anxiety, run by Centre Hospitalier Departemental Vendee at 44 sites 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 1 inclusion and 6 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 10 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites 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?
Post traumatic Stress Disorder (time frame: three month after patient's death). 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 NCT01818895, which also lists 1 linked publication.
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 10 Jul 2015.