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Completed

NCT Number: NCT01818895

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

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.

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Key information

Conditions

Withdrawal Anxiety Anxiety Disorders Behavior Behavioral Symptoms Death Depression Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Posttraumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Réanimation médicale CHU, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Post traumatic Stress Disorder

    Time frame: 12 months after patient's death

    Post traumatic stress disorder of relatives assessed by the Impact of Event Scale -revised (IES-R)

  2. Anxiety and depression

    Time frame: 3, 6 and 12 months after patient's death

    Anxiety and depression of the relatives, assessed by the hospital Anxiety and Depression Scale (HADS)

  3. Complicated grief

    Time frame: 6 and 12 months after patient's death

    Complicated grief as assessed by the Inventory of Complicated Grief (ICG) scale

  4. Relative's satisfaction

    Time frame: 3 months after patient's death

    Questionnaire on relative's satisfaction

  5. Nurse's satisfaction

    Time frame: within day 1 after patient's death

    Questionnaire on nurse's satisfaction

  6. Physician's satisfaction

    Time frame: within day 1 after patient's death

    Questionnaire on physician's satisfaction

  7. Burn out syndrome of the nurse

    Time frame: within day 1 after patient's death

    Burn out syndrome of the patient's nurse as assessed by the Job Strain scale

  8. Burn out syndrome of the physician

    Time frame: within day 1 after patient's death

    Burn out syndrome of the patient's physician as assessed by the Job Strain scale

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • Poitiers University Hospital
  • University Hospital, Tours

Registry information

Official study 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

Acronym: ARREVE

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 27, 2013
Registry last updated
Jul 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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