End-of-life Care in Mechanically Ventilated Patients: Impact of a Comprehensive Palliative Care Protocol in the Intensive Care Setting

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNantes University Hospital

About this trial

The ARREVE-3 trial will evaluate whether a structured palliative care protocol can improve end-of-life management for mechanically ventilated ICU patients in whom a decision to withdraw life-sustaining therapies has been made. This cluster-randomized controlled trial compares protocol-based care with usual practice across participating centers. The intervention includes comprehensive guidance on symptom management, sedation, nursing care, withdrawal procedures, and family support, supported by standardized staff training. The primary endpoint is adherence to recommended end-of-life practices, while secondary outcomes assess patient comfort, communication with relatives, and the impact on families and healthcare professionals

Eligibility criteria

Qualifiers

Age ≥ 18 years

ICU admission for more than 48 hours

Receiving invasive mechanical ventilation

A documented decision to withdraw life-sustaining therapies, made through a multidisciplinary collegial process and communicated to the designated surrogate decision-maker, family, or relatives

Disqualifiers

Presence of a tracheostomy

Brain death or involvement in an organ donation procedure

Absence of any visit from a relative

Subject to legal guardianship or other legal protection measures

Trial design

Treatments tested in this trial

  • Protocol for palliative care and life-support withdrawal

Treatment groups

720 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Nantes University Hospital

Lead sponsor

University of Burgundy

Collaborator

Centre Hospitalier Universitaire de Saint Louis APHP

Collaborator

University Hospital, Tours

Collaborator