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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Centre Hospitalier Universitaire, Poitiers, France
Institut National de la Santé Et de la Recherche Médicale, France
University Hospital, Tours
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier:
NCT01818895
First received: March 21, 2013
Last updated: June 14, 2014
Last verified: June 2014
  Purpose

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.


Condition
Withdrawal
Anxiety
Depression
Posttraumatic Stress Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Departemental Vendee:

Primary Outcome Measures:
  • Post traumatic Stress Disorder [ Time Frame: three month after patient's death ] [ Designated as safety issue: No ]
    Post traumatic Stress Disorder as assessed by the Impact of event Scale-revised(IES-R)


Secondary Outcome Measures:
  • Post traumatic Stress Disorder [ Time Frame: 12 months after patient's death ] [ Designated as safety issue: No ]
    Post traumatic stress disorder of relatives assessed by the Impact of Event Scale -revised (IES-R)

  • Anxiety and depression [ Time Frame: 3, 6 and 12 months after patient's death ] [ Designated as safety issue: No ]
    Anxiety and depression of the relatives, assessed by the hospital Anxiety and Depression Scale (HADS)

  • Complicated grief [ Time Frame: 6 and 12 months after patient's death ] [ Designated as safety issue: No ]
    Complicated grief as assessed by the Inventory of Complicated Grief (ICG) scale

  • Relative's satisfaction [ Time Frame: 3 months after patient's death ] [ Designated as safety issue: No ]
    Questionnaire on relative's satisfaction

  • Nurse's satisfaction [ Time Frame: within day 1 after patient's death ] [ Designated as safety issue: No ]
    Questionnaire on nurse's satisfaction

  • Physician's satisfaction [ Time Frame: within day 1 after patient's death ] [ Designated as safety issue: No ]
    Questionnaire on physician's satisfaction

  • Burn out syndrome of the nurse [ Time Frame: within day 1 after patient's death ] [ Designated as safety issue: No ]
    Burn out syndrome of the patient's nurse as assessed by the Job Strain scale

  • Burn out syndrome of the physician [ Time Frame: within day 1 after patient's death ] [ Designated as safety issue: No ]
    Burn out syndrome of the patient's physician as assessed by the Job Strain scale


Estimated Enrollment: 400
Study Start Date: April 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Withdrawal of mechanical ventilation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients admitted in ICU with end of life decision to withdraw invasive mechanical ventilation after at least 48 hours of ICU stay

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01818895

Locations
France
Réanimation médicale CHU
Angers, France, 49000
Réanimation, CH d'Angoulême
Angoulême, France
Réanimation, CH d'Annecy
Annecy, France
Réanimation
Belfort, France
Réanimation, CHU
Bordeaux, France
CHU Pellegrin Tripode
Bordeaux, France, 33076
CHU Ambroise Paré
Boulogne, France
CHU La Cavale Blanche
Brest, France
CHU de Côte de Lumière
Caen, France
Centre Hospitalier, Service de réanimation
Charleville Mézières, France
CH de Chartres
Chartres, France
CHU Gabriel Montpied, Clermont Ferrand
Clermont Ferrand, France, 63003
CHU Louis Mourier
Colombes, France
CH de Dieppe
Dieppe, France, 76202
CHU Dijon
Dijon, France, 21079
CHU Raymond Poincaré
Garches, France, 92380
CHU Grenoble
Grenoble, France, 38043
CHD de la Vendée
La Roche sur Yon, France
CH de La Rochelle
La Rochelle, France
CH du Mans
Le Mans, France
CH du Puy
Le Puy en Velay, France
CH Docteur Schaffner
Lens, France, 62307
CHU de Lille
Lille, France
CH de Lorient
Lorient, France
CHU Marseille, Hopital La Timone
Marseille, France, 13000
CHU de Marseille, Hopital Nord
Marseille, France
CH Marc Jacquet
Melun, France, 77000
CH de Montauban
Montauban, France, 82013
CHI André Grégoire
Montreuil, France, 93105
CH de Mulhouse
Mulhouse, France
CHU de Nantes - Hôtel Dieu
Nantes, France, 44093
CHU Orléans - Réanimation Médicale
Orleans, France
CHU Lariboisière
Paris, France
Groupe Hospitalier Paris Saint Joseph
Paris, France, 75014
CHU Saint Louis
Paris, France, 75010
CHU Hopital Européen Georges Pompidou
Paris, France
CHU Paris Cochin
Paris, France, 75014
CHU Poitiers
Poitiers, France, 86021
CH de Roanne
Roanne, France
Hôpital Delafontaine
Saint Denis, France, 93200
CH de Saint-Nazaire
Saint-Nazaire, France
Hôpital Foch
Suresnes, France, 92150
CHU Tours
Tours, France, 37044
Institut Gustave Roussy
Villejuif, France
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Centre Hospitalier Universitaire, Poitiers, France
Institut National de la Santé Et de la Recherche Médicale, France
University Hospital, Tours
Investigators
Principal Investigator: Jean Reignier, MD, PhD Centre Hospitalier Départemental de la Vendée, La Roche sur Yon, France
Principal Investigator: René Robert, MD Centre Hospitalier Universitaire, Poitiers, France
  More Information

No publications provided

Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT01818895     History of Changes
Other Study ID Numbers: CHD 018-13
Study First Received: March 21, 2013
Last Updated: June 14, 2014
Health Authority: France: French Data Protection Authority

Keywords provided by Centre Hospitalier Departemental Vendee:
Mechanical ventilation
End of life
Extubation
Terminal weaning
Complicated grief

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on July 29, 2014