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

This study is currently recruiting participants.
Verified October 2013 by Centre Hospitalier Departemental Vendee
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: October 21, 2013
Last verified: October 2013
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01818895

Contacts
Contact: Jean Reignier, MD, PhD 0251446212 jean.reignier@chd-vendee.fr
Contact: René Robert, MD Rene.ROBERT@chu-poitiers.fr]

Locations
France
Réanimation médicale CHU Recruiting
Angers, France, 49000
Contact: Nicolas Lerolle, MD         
Principal Investigator: Nicolas Lerolle, MD         
Réanimation, CH d'Angoulême Recruiting
Angoulême, France
Principal Investigator: Desachy, MD         
Réanimation, CH d'Annecy Recruiting
Annecy, France
Principal Investigator: Hyacynthe, MD         
Réanimation Recruiting
Belfort, France
Principal Investigator: Feissel, MD         
Réanimation, CHU Recruiting
Bordeaux, France
Principal Investigator: Guisset, MD         
CHU Pellegrin Tripode Recruiting
Bordeaux, France, 33076
Principal Investigator: Alexandre Boyer, MD         
CHU Ambroise Paré Recruiting
Boulogne, France
Principal Investigator: Repesse, MD         
CHU La Cavale Blanche Recruiting
Brest, France
Principal Investigator: Anne Renault, MD         
CHU de Côte de Lumière Recruiting
Caen, France
Principal Investigator: Seguin, MD         
Centre Hospitalier, Service de réanimation Recruiting
Charleville Mézières, France
Principal Investigator: Philippe Mateu, MD         
CH de Chartres Recruiting
Chartres, France
Principal Investigator: Audibert, MD         
CHU Gabriel Montpied, Clermont Ferrand Recruiting
Clermont Ferrand, France, 63003
Principal Investigator: Alexandre Lautrette, MD         
CHU Louis Mourier Recruiting
Colombes, France
Principal Investigator: Jonathan Messika, MD         
CH de Dieppe Recruiting
Dieppe, France, 76202
Principal Investigator: Jean-Philippe Rigaud, MD         
CHU Dijon Recruiting
Dijon, France, 21079
Principal Investigator: Jean-Pierre Quenot, MD         
CHU Raymond Poincaré Recruiting
Garches, France, 92380
Principal Investigator: Diane Friedman, MD         
CHU Grenoble Recruiting
Grenoble, France, 38043
Principal Investigator: Rebecca Hamidfar-Roy, MD         
CHD de la Vendée Recruiting
La Roche sur Yon, France
Principal Investigator: Jean Reignier, MD         
CH de La Rochelle Recruiting
La Rochelle, France
Principal Investigator: Olivier Lesieur, MD         
CH du Mans Recruiting
Le Mans, France
Principal Investigator: Tirot, MD         
CH du Puy Not yet recruiting
Le Puy en Velay, France
Principal Investigator: Claud, MD         
CH Docteur Schaffner Recruiting
Lens, France, 62307
Principal Investigator: Didier Thevenin, MD         
CHU de Lille Recruiting
Lille, France
Principal Investigator: Jourdain, MD         
CH de Lorient Recruiting
Lorient, France
Principal Investigator: Belliard, MD         
CHU de Marseille, Hopital Nord Recruiting
Marseille, France
Principal Investigator: Adda, MD         
CHU Marseille, Hopital La Timone Recruiting
Marseille, France, 13000
Principal Investigator: Beatrice Eon         
CH Marc Jacquet Recruiting
Melun, France, 77000
Principal Investigator: Jochmans, MD         
CH de Montauban Recruiting
Montauban, France, 82013
Principal Investigator: Frédéric Bellec         
CHI André Grégoire Recruiting
Montreuil, France, 93105
Principal Investigator: Vincent Das, MD         
CH de Mulhouse Recruiting
Mulhouse, France
Principal Investigator: Ganster, MD         
CHU de Nantes - Hôtel Dieu Recruiting
Nantes, France, 44093
Principal Investigator: Antoine Roquilly, MD         
CHU Orléans - Réanimation Médicale Recruiting
Orleans, France
Contact: Chantal BROSSARD       chantal.brossard@chr-orleans.fr   
Principal Investigator: Barbier, MD         
CHU Saint Louis Recruiting
Paris, France, 75010
Principal Investigator: Emmanuel Canet, MD         
Groupe Hospitalier Paris Saint Joseph Not yet recruiting
Paris, France, 75014
Principal Investigator: Maité Garrouste-Orgeas, MD         
CHU Hopital Européen Georges Pompidou Recruiting
Paris, France
Principal Investigator: Robin, MD         
CHU Paris Cochin Recruiting
Paris, France, 75014
Principal Investigator: Bourcier, MD         
CHU Lariboisière Recruiting
Paris, France
Principal Investigator: Bruno Mégarbanne, MD         
CHU Poitiers Recruiting
Poitiers, France, 86021
Contact: , CRA         
Principal Investigator: René Robert, MD         
CH de Roanne Recruiting
Roanne, France
Principal Investigator: Philippon-Jouve, MD         
Hôpital Delafontaine Recruiting
Saint Denis, France, 93200
Principal Investigator: Daniel Silva, MD         
CH de Saint-Nazaire Recruiting
Saint-Nazaire, France
Principal Investigator: Morin-Longuet, MD         
Hôpital Foch Recruiting
Suresnes, France, 92150
Principal Investigator: Jérome Devaquet, MD         
CH de Toulon Not yet recruiting
Toulon, France
Principal Investigator: Embriaco, MD         
CHU Tours Recruiting
Tours, France, 37044
Principal Investigator: Emmanuelle Mercier, MD         
Institut Gustave Roussy Recruiting
Villejuif, France
Principal Investigator: Chalumeau-Lemoine, MD         
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: October 21, 2013
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 April 15, 2014