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

NCT ID: NCT01818895

Last Updated: 2015-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

458 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Withdrawal Anxiety Depression Posttraumatic Stress Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Withdrawal of mechanical ventilation

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Tours

OTHER

Sponsor Role collaborator

Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Reignier, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Départemental de la Vendée, La Roche sur Yon, France

René Robert, MD

Role: PRINCIPAL_INVESTIGATOR

Poitiers University Hospital

Locations

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Réanimation médicale CHU

Angers, , France

Site Status

Réanimation, CH d'Angoulême

Angoulême, , France

Site Status

Réanimation, CH d'Annecy

Annecy, , France

Site Status

Réanimation

Belfort, , France

Site Status

CHU Pellegrin Tripode

Bordeaux, , France

Site Status

Réanimation, CHU

Bordeaux, , France

Site Status

CHU Ambroise Paré

Boulogne, , France

Site Status

CHU La Cavale Blanche

Brest, , France

Site Status

CHU de Côte de Lumière

Caen, , France

Site Status

Centre Hospitalier, Service de réanimation

Charleville-Mézières, , France

Site Status

CH de Chartres

Chartres, , France

Site Status

CHU Gabriel Montpied, Clermont Ferrand

Clermont-Ferrand, , France

Site Status

CHU Louis Mourier

Colombes, , France

Site Status

CH de Dieppe

Dieppe, , France

Site Status

CHU Dijon

Dijon, , France

Site Status

CHU Raymond Poincaré

Garches, , France

Site Status

CHU Grenoble

Grenoble, , France

Site Status

CHD de la Vendée

La Roche-sur-Yon, , France

Site Status

CH de La Rochelle

La Rochelle, , France

Site Status

CH du Mans

Le Mans, , France

Site Status

CH du Puy

Le Puy-en-Velay, , France

Site Status

CH Docteur Schaffner

Lens, , France

Site Status

CHU de Lille

Lille, , France

Site Status

CH de Lorient

Lorient, , France

Site Status

CHU Marseille, Hopital La Timone

Marseille, , France

Site Status

CHU de Marseille, Hopital Nord

Marseille, , France

Site Status

CH Marc Jacquet

Melun, , France

Site Status

CH de Montauban

Montauban, , France

Site Status

CHI André Grégoire

Montreuil, , France

Site Status

CH de Mulhouse

Mulhouse, , France

Site Status

CHU de Nantes - Hôtel Dieu

Nantes, , France

Site Status

CHU Orléans - Réanimation Médicale

Orléans, , France

Site Status

CHU Saint Louis

Paris, , France

Site Status

CHU Paris Cochin

Paris, , France

Site Status

Groupe Hospitalier Paris Saint Joseph

Paris, , France

Site Status

CHU Hopital Européen Georges Pompidou

Paris, , France

Site Status

CHU Lariboisière

Paris, , France

Site Status

CHU Poitiers

Poitiers, , France

Site Status

CH de Roanne

Roanne, , France

Site Status

Hôpital Delafontaine

Saint-Denis, , France

Site Status

CH de Saint-Nazaire

Saint-Nazaire, , France

Site Status

Hôpital Foch

Suresnes, , France

Site Status

CHU Tours

Tours, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 28936597 (View on PubMed)

Other Identifiers

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CHD 018-13

Identifier Type: -

Identifier Source: org_study_id

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