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Clinical Trials/NCT01818895
NCT01818895
Completed
N/A

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

Centre Hospitalier Departemental Vendee44 sites in 1 country458 target enrollmentApril 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Withdrawal
Sponsor
Centre Hospitalier Departemental Vendee
Enrollment
458
Locations
44
Primary Endpoint
Post traumatic Stress Disorder
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
May 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Post traumatic Stress Disorder

Time Frame: three month after patient's death

Post traumatic Stress Disorder as assessed by the Impact of event Scale-revised(IES-R)

Secondary Outcomes

  • Complicated grief(6 and 12 months after patient's death)
  • Burn out syndrome of the physician(within day 1 after patient's death)
  • Post traumatic Stress Disorder(12 months after patient's death)
  • Relative's satisfaction(3 months after patient's death)
  • Physician's satisfaction(within day 1 after patient's death)
  • Burn out syndrome of the nurse(within day 1 after patient's death)
  • Anxiety and depression(3, 6 and 12 months after patient's death)
  • Nurse's satisfaction(within day 1 after patient's death)

Study Sites (44)

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