CClinicalTrials.gg
CompletedNCT01818895ARREVEUpdated Jul 10, 2015

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

An observational study in Withdrawal, Anxiety and Depression, sponsored by Centre Hospitalier Departemental Vendee. Completed at 44 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-10.

Sponsored by Centre Hospitalier Departemental Vendee · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
458
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Withdrawal
  • Anxiety
  • Depression
  • Posttraumatic Stress Disorder

Keywords

  • Mechanical ventilation
  • End of life
  • Extubation
  • Terminal weaning
  • Complicated grief
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In context

Stress Disorders, Post-Traumatic

2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 553 are open to participants now.

This study's enrollment of 458 is above the median of 136 across 295 observational studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

Centre Hospitalier Departemental Vendee is the lead sponsor of 81 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Inclusion criteria

  • End of life decision to withdraw invasive mechanical ventilation after at least 48 hours of ICU stay

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
458 participants (actual)
Patient registry
No

Groups and cohorts

  • Withdrawal of mechanical ventilation
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What researchers measure

Primary outcomes

  1. Post traumatic Stress Disorder

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

    Time frame: three month after patient's death

Secondary outcomes

  1. Post traumatic Stress Disorder

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

    Time frame: 12 months after patient's death

  2. Anxiety and depression

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

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

  3. Complicated grief

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

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

  4. Relative's satisfaction

    Questionnaire on relative's satisfaction

    Time frame: 3 months after patient's death

  5. Nurse's satisfaction

    Questionnaire on nurse's satisfaction

    Time frame: within day 1 after patient's death

  6. Physician's satisfaction

    Questionnaire on physician's satisfaction

    Time frame: within day 1 after patient's death

  7. Burn out syndrome of the nurse

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

    Time frame: within day 1 after patient's death

  8. Burn out syndrome of the physician

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

    Time frame: within day 1 after patient's death

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Study locations

44 sites
  • Réanimation médicale CHU
    Angers, 49000, France
  • Réanimation, CH d'Angoulême
    Angoulême, France
  • Réanimation, CH d'Annecy
    Annecy, France
  • Réanimation
    Belfort, France
  • CHU Pellegrin Tripode
    Bordeaux, 33076, France
  • Réanimation, CHU
    Bordeaux, France
  • 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, 63003, France
  • CHU Louis Mourier
    Colombes, France
  • CH de Dieppe
    Dieppe, 76202, France
  • CHU Dijon
    Dijon, 21079, France
  • CHU Raymond Poincaré
    Garches, 92380, France
  • CHU Grenoble
    Grenoble, 38043, France
  • 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, 62307, France
  • CHU de Lille
    Lille, France
  • CH de Lorient
    Lorient, France
  • CHU Marseille, Hopital La Timone
    Marseille, 13000, France
  • CHU de Marseille, Hopital Nord
    Marseille, France
  • CH Marc Jacquet
    Melun, 77000, France
  • CH de Montauban
    Montauban, 82013, France
  • CHI André Grégoire
    Montreuil, 93105, France
  • CH de Mulhouse
    Mulhouse, France
  • CHU de Nantes - Hôtel Dieu
    Nantes, 44093, France
  • CHU Orléans - Réanimation Médicale
    Orleans, France
  • CHU Saint Louis
    Paris, 75010, France
  • CHU Paris Cochin
    Paris, 75014, France
  • Groupe Hospitalier Paris Saint Joseph
    Paris, 75014, France
  • CHU Hopital Européen Georges Pompidou
    Paris, France
  • CHU Lariboisière
    Paris, France
  • CHU Poitiers
    Poitiers, 86021, France
  • CH de Roanne
    Roanne, France
  • Hôpital Delafontaine
    Saint Denis, 93200, France
  • CH de Saint-Nazaire
    Saint-Nazaire, France
  • Hôpital Foch
    Suresnes, 92150, France
  • CHU Tours
    Tours, 37044, France
  • Institut Gustave Roussy
    Villejuif, France
08

References and documents

Publications

  • Robert R, Le Gouge A, Kentish-Barnes N, Cottereau A, Giraudeau B, Adda M, Annane D, Audibert J, Barbier F, Bardou P, Bourcier S, Bourenne J, Boyer A, Brenas F, Das V, Desachy A, Devaquet J, Feissel M, Ganster F, Garrouste-Orgeas M, Grillet G, Guisset O, Hamidfar-Roy R, Hyacinthe AC, Jochmans S, Jourdain M, Lautrette A, Lerolle N, Lesieur O, Lion F, Mateu P, Megarbane B, Merceron S, Mercier E, Messika J, Morin-Longuet P, Philippon-Jouve B, Quenot JP, Renault A, Repesse X, Rigaud JP, Robin S, Roquilly A, Seguin A, Thevenin D, Tirot P, Vinatier I, Azoulay E, Reignier J. Terminal weaning or immediate extubation for withdrawing mechanical ventilation in critically ill patients (the ARREVE observational study). Intensive Care Med. 2017 Dec;43(12):1793-1807. doi: 10.1007/s00134-017-4891-0. Epub 2017 Sep 22. Erratum In: Intensive Care Med. 2017 Dec;43(12):1942-1943. doi: 10.1007/s00134-017-4999-2. PubMed 28936597 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01818895
Lead sponsor
Centre Hospitalier Departemental Vendee
Collaborators
Poitiers University Hospital, Institut National de la Santé Et de la Recherche Médicale, France, University Hospital, Tours
Responsible party
Sponsor
First posted
Mar 27, 2013
Start date
Apr 2013
Primary completion
Mar 2015
Completion
May 2015
Last update
Jul 10, 2015

Study contacts

Jean Reignier, MD, PhD
principal investigator · Centre Hospitalier Départemental de la Vendée, La Roche sur Yon, France
René Robert, MD
principal investigator · Poitiers University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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