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

Among ICU patients who die after a decision to withdraw life-sustaining therapies, most are receiving mechanical ventilation (MV). Withdrawal of MV may cause discomfort, and end-of-life practices can have a lasting impact on both families and healthcare professionals. Despite international guidelines and recent legislative changes in France, end-of-life practices in the ICU remain highly variable, indicating substantial opportunities for improvement in patient comfort-focused management.

The ARREVE-3 trial aimes to determine whether a structured palliative care protocol for mechanically ventilated patients undergoing withdrawal of life-sustaining therapies improves the quality of the dying process. Developed in collaboration with palliative care specialists, a psychologist, and a sociologist, the protocol provides standardized guidance on pharmacological and non-pharmacological interventions, including symptom assessment tools, sedation strategies, nursing care, and procedures for withdrawal of life-sustaining treatment. Structured recommendations for support of relatives are also included.

ARREVE-3 is a pragmatic, interventional, cluster-randomized controlled trial, with participating ICUs being unit of randomization to minimize contamination between study arms. ICUs randomized to the intervention arm will apply the palliative care protocol, whereas control ICUs will continue to follow usual care. Physicians and nurses in intervention ICUs will receive standardized training from the coordinating team, complemented by a video-based educational module. Designated local champions within each ICU will support implementation and adherence.to the protocol.

The primary endpoint is adherence to the protocol for end-of-life care. Secondary outcomes include patient comfort, quality of communication with relatives, and the impact of the end-of-life process on relatives and healthcare professionals.

• Evaluation of Sedation [Time frame: From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days]
• Evaluation of Sedation [Time frame: From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days]
• Proportion of Patients Receiving Medications Other Than Sedatives [Time frame: From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days]
• Administration of neuromuscular blocking agents [Time frame: From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days]
• Administration of scopolamine [Time frame: From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days]
• Administration of paracetamol (acetaminophen) [Time frame: From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days]
• Administration of Receiving antiemetic agents [Time frame: From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days]
• The Semi-Lateral (¾ Lateral) Position [Time frame: From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days]
• Life-Sustaining Organ Support Management [Time frame: From inclusion to date of ICU discharge or death, whichever came first, assessed up to 28 days]
• Life-Sustaining Organ Support Management [Time frame: From inclusion to death, assessed up to 28 days]
• Life-Sustaining Organ Support Management [Time frame: From inclusion to date of ICU discharge or death, whichever came first, assessed up to 28 days]
• Life-Sustaining Organ Support Management [Time frame: From inclusion to date of ICU discharge or death, whichever came first, assessed up to 28 days]