Terminal Weaning of Mechanical Ventilation or Extubation in Anticipation of Death in the Intensive Care Unit

Depression Clinical Trial

— ARREVE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01818895
• Other study ID #: CHD 018-13
• Status: Completed
• Phase: N/A
• First received: March 21, 2013
• Last updated: July 9, 2015
• Start date: April 2013
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational

Clinical 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. The investigators primary hypothesis is that extubation is associated with less symptoms of post-traumatic stress disorders in relatives, as compared to terminal weaning.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 458
• Est. completion date: May 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anxiety
• Depression
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Withdrawal

Locations

Country	Name	City	State
France	Réanimation médicale CHU	Angers
France	Réanimation, CH d'Angoulême	Angoulême
France	Réanimation, CH d'Annecy	Annecy
France	Réanimation	Belfort
France	CHU Pellegrin Tripode	Bordeaux
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
France	CHU Louis Mourier	Colombes
France	CH de Dieppe	Dieppe
France	CHU Dijon	Dijon
France	CHU Raymond Poincaré	Garches
France	CHU Grenoble	Grenoble
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
France	CHU de Lille	Lille
France	CH de Lorient	Lorient
France	CHU de Marseille, Hopital Nord	Marseille
France	CHU Marseille, Hopital La Timone	Marseille
France	CH Marc Jacquet	Melun
France	CH de Montauban	Montauban
France	CHI André Grégoire	Montreuil
France	CH de Mulhouse	Mulhouse
France	CHU de Nantes - Hôtel Dieu	Nantes
France	CHU Orléans - Réanimation Médicale	Orleans
France	CHU Hopital Européen Georges Pompidou	Paris
France	CHU Lariboisière	Paris
France	CHU Paris Cochin	Paris
France	CHU Saint Louis	Paris
France	Groupe Hospitalier Paris Saint Joseph	Paris
France	CHU Poitiers	Poitiers
France	CH de Roanne	Roanne
France	Hôpital Delafontaine	Saint Denis
France	CH de Saint-Nazaire	Saint-Nazaire
France	Hôpital Foch	Suresnes
France	CHU Tours	Tours
France	Institut Gustave Roussy	Villejuif

Sponsors (4)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee	Institut National de la Santé Et de la Recherche Médicale, France, Poitiers University Hospital, University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Post traumatic Stress Disorder	Post traumatic stress disorder of relatives assessed by the Impact of Event Scale -revised (IES-R)	12 months after patient's death	No
Secondary	Anxiety and depression	Anxiety and depression of the relatives, assessed by the hospital Anxiety and Depression Scale (HADS)	3, 6 and 12 months after patient's death	No
Secondary	Complicated grief	Complicated grief as assessed by the Inventory of Complicated Grief (ICG) scale	6 and 12 months after patient's death	No
Secondary	Relative's satisfaction	Questionnaire on relative's satisfaction	3 months after patient's death	No
Secondary	Nurse's satisfaction	Questionnaire on nurse's satisfaction	within day 1 after patient's death	No
Secondary	Physician's satisfaction	Questionnaire on physician's satisfaction	within day 1 after patient's death	No
Secondary	Burn out syndrome of the nurse	Burn out syndrome of the patient's nurse as assessed by the Job Strain scale	within day 1 after patient's death	No
Secondary	Burn out syndrome of the physician	Burn out syndrome of the patient's physician as assessed by the Job Strain scale	within day 1 after patient's death	No