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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01818895

Acronym

ARREVE

Enrollment

458

Registered

2013-03-27

Start date

2013-04-30

Completion date

2015-05-31

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Posttraumatic Stress Disorder, Withdrawal

Keywords

Mechanical ventilation, End of life, Extubation, Terminal weaning, Complicated grief

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Outcome results