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

Completed

• Conditions: Anxiety; Withdrawal; Depression; Posttraumatic Stress Disorder

• Registration Number: NCT01818895
• Lead Sponsor: Centre Hospitalier Departemental Vendee

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-21
• Study First Submitted QC: 2013-03-26
• Study First Posted: 2013-03-27
• Study Start: 2013-04
• Primary Completion: 2015-03
• Study Completion: 2015-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-09
• Last Update Posted: 2015-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 458

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post traumatic Stress Disorder	three month after patient's death	Post traumatic Stress Disorder as assessed by the Impact of event Scale-revised(IES-R)

Secondary Outcome Measures

Name	Time	Method
Complicated grief	6 and 12 months after patient's death	Complicated grief as assessed by the Inventory of Complicated Grief (ICG) scale
Burn out syndrome of the physician	within day 1 after patient's death	Burn out syndrome of the patient's physician as assessed by the Job Strain scale
Post traumatic Stress Disorder	12 months after patient's death	Post traumatic stress disorder of relatives assessed by the Impact of Event Scale -revised (IES-R)
Relative's satisfaction	3 months after patient's death	Questionnaire on relative's satisfaction
Physician's satisfaction	within day 1 after patient's death	Questionnaire on physician's satisfaction
Burn out syndrome of the nurse	within day 1 after patient's death	Burn out syndrome of the patient's nurse as assessed by the Job Strain scale
Anxiety and depression	3, 6 and 12 months after patient's death	Anxiety and depression of the relatives, assessed by the hospital Anxiety and Depression Scale (HADS)
Nurse's satisfaction	within day 1 after patient's death	Questionnaire on nurse's satisfaction

Trial Locations

Locations (44)

Réanimation médicale CHU; 🇫🇷 Angers, France

Réanimation, CH d'Angoulême; 🇫🇷 Angoulême, France

Réanimation, CH d'Annecy; 🇫🇷 Annecy, France

Réanimation, CHU; 🇫🇷 Bordeaux, France

CHU Pellegrin Tripode; 🇫🇷 Bordeaux, France

CHU Ambroise Paré; 🇫🇷 Boulogne, France

Réanimation; 🇫🇷 Belfort, France

CHU de Côte de Lumière; 🇫🇷 Caen, France

CH du Mans; 🇫🇷 Le Mans, France

CHU La Cavale Blanche; 🇫🇷 Brest, France

Centre Hospitalier, Service de réanimation; 🇫🇷 Charleville Mézières, France

CH de Chartres; 🇫🇷 Chartres, France

CHU Poitiers; 🇫🇷 Poitiers, France

CHU Gabriel Montpied, Clermont Ferrand; 🇫🇷 Clermont Ferrand, France

CHU Louis Mourier; 🇫🇷 Colombes, France

CHU Lariboisière; 🇫🇷 Paris, 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 Puy; 🇫🇷 Le Puy en Velay, France

CH Docteur Schaffner; 🇫🇷 Lens, France

CHU de Lille; 🇫🇷 Lille, France

CH de Lorient; 🇫🇷 Lorient, France

CHU Marseille, Hopital La Timone; 🇫🇷 Marseille, France

CH Marc Jacquet; 🇫🇷 Melun, France

CHU de Marseille, Hopital Nord; 🇫🇷 Marseille, 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 Saint Louis; 🇫🇷 Paris, France

CHU Paris Cochin; 🇫🇷 Paris, France

Groupe Hospitalier Paris Saint Joseph; 🇫🇷 Paris, France

CHU Hopital Européen Georges Pompidou; 🇫🇷 Paris, 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, France