Terminal Weaning of Mechanical Ventilation or Extubation in Anticipation of Death in the Intensive Care Unit
ARREVE
1 other identifier
observational
458
1 country
44
Brief 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. The investigators primary hypothesis is that extubation is associated with less symptoms of post-traumatic stress disorders in relatives, as compared to terminal weaning.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2013
Typical duration for all trials
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2013
CompletedFirst Posted
Study publicly available on registry
March 27, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJuly 10, 2015
July 1, 2015
1.9 years
March 21, 2013
July 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post traumatic Stress Disorder
Post traumatic Stress Disorder as assessed by the Impact of event Scale-revised(IES-R)
three month after patient's death
Secondary Outcomes (8)
Post traumatic Stress Disorder
12 months after patient's death
Anxiety and depression
3, 6 and 12 months after patient's death
Complicated grief
6 and 12 months after patient's death
Relative's satisfaction
3 months after patient's death
Nurse's satisfaction
within day 1 after patient's death
- +3 more secondary outcomes
Study Arms (1)
Withdrawal of mechanical ventilation
Eligibility Criteria
Patients admitted in ICU with end of life decision to withdraw invasive mechanical ventilation after at least 48 hours of ICU stay
You may qualify if:
- End of life decision to withdraw invasive mechanical ventilation after at least 48 hours of ICU stay
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier Departemental Vendeelead
- Poitiers University Hospitalcollaborator
- Institut National de la Santé Et de la Recherche Médicale, Francecollaborator
- University Hospital, Tourscollaborator
Study Sites (44)
Réanimation médicale CHU
Angers, 49000, France
Réanimation, CH d'Angoulême
Angoulême, France
Réanimation, CH d'Annecy
Annecy, France
Réanimation
Belfort, France
CHU Pellegrin Tripode
Bordeaux, 33076, France
Réanimation, CHU
Bordeaux, France
CHU Ambroise Paré
Boulogne, France
CHU La Cavale Blanche
Brest, France
CHU de Côte de Lumière
Caen, France
Centre Hospitalier, Service de réanimation
Charleville-Mézières, France
CH de Chartres
Chartres, France
CHU Gabriel Montpied, Clermont Ferrand
Clermont-Ferrand, 63003, France
CHU Louis Mourier
Colombes, France
CH de Dieppe
Dieppe, 76202, France
CHU Dijon
Dijon, 21079, France
CHU Raymond Poincaré
Garches, 92380, France
CHU Grenoble
Grenoble, 38043, France
CHD de la Vendée
La Roche-sur-Yon, France
CH de La Rochelle
La Rochelle, France
CH du Mans
Le Mans, France
CH du Puy
Le Puy-en-Velay, France
CH Docteur Schaffner
Lens, 62307, France
CHU de Lille
Lille, France
CH de Lorient
Lorient, France
CHU Marseille, Hopital La Timone
Marseille, 13000, France
CHU de Marseille, Hopital Nord
Marseille, France
CH Marc Jacquet
Melun, 77000, France
CH de Montauban
Montauban, 82013, France
CHI André Grégoire
Montreuil, 93105, France
CH de Mulhouse
Mulhouse, France
CHU de Nantes - Hôtel Dieu
Nantes, 44093, France
CHU Orléans - Réanimation Médicale
Orléans, France
CHU Saint Louis
Paris, 75010, France
CHU Paris Cochin
Paris, 75014, France
Groupe Hospitalier Paris Saint Joseph
Paris, 75014, France
CHU Hopital Européen Georges Pompidou
Paris, France
CHU Lariboisière
Paris, France
CHU Poitiers
Poitiers, 86021, France
CH de Roanne
Roanne, France
Hôpital Delafontaine
Saint-Denis, 93200, France
CH de Saint-Nazaire
Saint-Nazaire, France
Hôpital Foch
Suresnes, 92150, France
CHU Tours
Tours, 37044, France
Institut Gustave Roussy
Villejuif, France
Related Publications (1)
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.
PMID: 28936597DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean Reignier, MD, PhD
Centre Hospitalier Départemental de la Vendée, La Roche sur Yon, France
- PRINCIPAL INVESTIGATOR
René Robert, MD
Poitiers University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2013
First Posted
March 27, 2013
Study Start
April 1, 2013
Primary Completion
March 1, 2015
Study Completion
May 1, 2015
Last Updated
July 10, 2015
Record last verified: 2015-07