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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Withdrawal, Anxiety, Depression, Posttraumatic Stress Disorder

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Withdrawal of mechanical ventilation<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Complicated grief | Complicated grief as assessed by the Inventory of Complicated Grief (ICG) scale | 6 and 12 months after patient's death | 
| Relative's satisfaction | Questionnaire on relative's satisfaction | 3 months after patient's death | 
| Nurse's satisfaction | Questionnaire on nurse's satisfaction | within day 1 after patient's death | 
| Physician's satisfaction | Questionnaire on physician's satisfaction | 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 | 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 | within day 1 after patient's death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical ventilation, End of life, Extubation, Terminal weaning, Complicated grief