Clinical trial NCT01818895: Terminal Weaning of Mechanical Ventilation or Extubation in Anticipation of Death in the Intensive Care Unit
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Withdrawal
Anxiety
Depression
Posttraumatic Stress Disorder
Keywords: Mechanical ventilation
End of life
Extubation
Terminal weaning
Complicated grief
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
Collaborators: name: Poitiers University Hospital
name: Institut National de la Santé Et de la Recherche Médicale, France
name: University Hospital, Tours
First posted: 2013-03-27
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted in ICU with end of life decision to withdraw invasive mechanical ventilation after at least 48 hours of ICU stay

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.


Eligibility criteria: Inclusion Criteria:

* End of life decision to withdraw invasive mechanical ventilation after at least 48 hours of ICU stay

Exclusion Criteria:

* 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

Primary outcomes:
measure: Post traumatic Stress Disorder
timeFrame: three month after patient's death
Secondary outcomes:
measure: Post traumatic Stress Disorder
timeFrame: 12 months after patient's death
measure: Anxiety and depression
timeFrame: 3, 6 and 12 months after patient's death
measure: Complicated grief
timeFrame: 6 and 12 months after patient's death
measure: Relative's satisfaction
timeFrame: 3 months after patient's death
measure: Nurse's satisfaction
timeFrame: within day 1 after patient's death
measure: Physician's satisfaction
timeFrame: within day 1 after patient's death
measure: Burn out syndrome of the nurse
timeFrame: within day 1 after patient's death
measure: Burn out syndrome of the physician
timeFrame: within day 1 after patient's death
Other outcomes:
Locations:
city: Angers
country: France
facility: Réanimation médicale CHU
city: Angoulême
country: France
facility: Réanimation, CH d'Angoulême
city: Annecy
country: France
facility: Réanimation, CH d'Annecy
city: Belfort
country: France
facility: Réanimation
city: Bordeaux
country: France
facility: CHU Pellegrin Tripode
city: Bordeaux
country: France
facility: Réanimation, CHU
city: Boulogne
country: France
facility: CHU Ambroise Paré
city: Brest
country: France
facility: CHU La Cavale Blanche
city: Caen
country: France
facility: CHU de Côte de Lumière
city: Charleville Mézières
country: France
facility: Centre Hospitalier, Service de réanimation
city: Chartres
country: France
facility: CH de Chartres
city: Clermont Ferrand
country: France
facility: CHU Gabriel Montpied, Clermont Ferrand
city: Colombes
country: France
facility: CHU Louis Mourier
city: Dieppe
country: France
facility: CH de Dieppe
city: Dijon
country: France
facility: CHU Dijon
city: Garches
country: France
facility: CHU Raymond Poincaré
city: Grenoble
country: France
facility: CHU Grenoble
city: La Roche sur Yon
country: France
facility: CHD de la Vendée
city: La Rochelle
country: France
facility: CH de La Rochelle
city: Le Mans
country: France
facility: CH du Mans
city: Le Puy en Velay
country: France
facility: CH du Puy
city: Lens
country: France
facility: CH Docteur Schaffner
city: Lille
country: France
facility: CHU de Lille
city: Lorient
country: France
facility: CH de Lorient
city: Marseille
country: France
facility: CHU Marseille, Hopital La Timone
city: Marseille
country: France
facility: CHU de Marseille, Hopital Nord
city: Melun
country: France
facility: CH Marc Jacquet
city: Montauban
country: France
facility: CH de Montauban
city: Montreuil
country: France
facility: CHI André Grégoire
city: Mulhouse
country: France
facility: CH de Mulhouse
city: Nantes
country: France
facility: CHU de Nantes - Hôtel Dieu
city: Orleans
country: France
facility: CHU Orléans - Réanimation Médicale
city: Paris
country: France
facility: CHU Saint Louis
city: Paris
country: France
facility: CHU Paris Cochin
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
city: Paris
country: France
facility: CHU Hopital Européen Georges Pompidou
city: Paris
country: France
facility: CHU Lariboisière
city: Poitiers
country: France
facility: CHU Poitiers
city: Roanne
country: France
facility: CH de Roanne
city: Saint Denis
country: France
facility: Hôpital Delafontaine
city: Saint-Nazaire
country: France
facility: CH de Saint-Nazaire
city: Suresnes
country: France
facility: Hôpital Foch
city: Tours
country: France
facility: CHU Tours
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre Hospitalier Départemental de la Vendée, La Roche sur Yon, France
name: Jean Reignier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Poitiers University Hospital
name: René Robert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.