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

N/ANot Yet RecruitingNCT07368010

Nantes University Hospital720 enrolled

Overview

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

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.

Study Type

Interventions

Protocol for palliative care and life-support withdrawalOTHER

In the intervention group, end-of-life care will be provided in accordance with the study protocol, which specifies pharmacological management, nursing care, management of life-sustaining organ support, procedures for the assessment of comfort and pain, and support for relatives. Medical and nursing staff in intervention centers will receive on-site, face-to-face training on the care protocol within each ICU. An instructional video detailing the protocol will also be available.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient: * 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 * At least one visit from a relative prior to the decision to withdraw life-sustaining therapies * Provision of informed consent for study participation, or, if the patient lacks decision-making capacity, consent obtained from a relative or legally authorized representative * Relative: * Age ≥ 18 years * Has received at least one medical update regarding the patient's clinical status from an ICU physician prior to the decision to withdraw life-sustaining therapies * Has provided informed consent for study participation Exclusion Criteria: * Patient: * 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 * Incarcerated patient * Participation in another interventional research study focused on end-of-life care * Pregnant or breastfeeding woman * Relative: * Inability to understand or speak French * Subject to legal guardianship or other legal protection measures

Outcomes

Primary Outcomes

To assess whether, compared with usual care, the implementation of a palliative care protocol for mechanically ventilated patients-combined with dedicated staff training-improves adherence to guidelines.

Proportion of patients receiving adequate sedation (RASS-5 within one hour before withdrawal of life-sustaining therapies) and withdrawal of mechanical ventilation

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

Secondary Outcomes

Evaluation of Sedation

Maximum rate of continuous infusion of each sedative agent administered (within 1 hour before the first withdrawal of life sustaining therapies and death)

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

Number of sedative boluses and number of dose escalations of continuous sedation between inclusion and death

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

Proportion of patients receiving neuromuscular blocking agents, scopolamine, paracetamol (acetaminophen), or 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

Administration of neuromuscular blocking agents

Proportion of patients receiving 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

Proportion of patients receiving 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)

Proportion of patients receiving 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

Proportion of patients 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

Proportion of patients positioned in the semi-lateral (¾ lateral) position 1 hour before treatment withdrawal and 1 hour before death

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

Proportion of patients receiving dialysis, vasoactive drug and/or ECMO at inclusion and at death

Time frame: From inclusion to date of ICU discharge or death, whichever came first, assessed up to 28 days

Life-Sustaining Organ Support Management

Proportion of patients in whom all life-sustaining therapies are discontinued before death

Time frame: From inclusion to death, assessed up to 28 days

Life-Sustaining Organ Support Management

Proportion of patients in whom all life-sustaining therapies are withdrawn concomitantly

Time frame: From inclusion to date of ICU discharge or death, whichever came first, assessed up to 28 days

Life-Sustaining Organ Support Management

Proportion of patients whith immediate extubation

Time frame: From inclusion to date of ICU discharge or death, whichever came first, assessed up to 28 days

Time from Inclusion to Extubation

Time interval between inclusion and extubation

Time frame: From inclusion to date of extubation, assessed up to 28 days

Assessment of Sedation

Proportion of patients with a Richmond Agitation-Sedation Scale (RASS) score of -5 or \> -4 (≥ -3) 1 hour before withdrawal of the first life-sustaining therapy (mechanical ventilation, vasopressors, or ECMO) and 1 hour before extubation

Time frame: From inclusion to date of ICU discharge or death, whichever came first, assessed up to 28 days

Assessment of Pain Management

Higher Behavioral Pain Scale (BPS) score 1 hour before withdrawal of the first life-sustaining therapy (mechanical ventilation, vasopressors, or ECMO); BPS min = 3, max = 12; Higher scores correlate with increased pain intensity.

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

Assessment of Comfort Management

Proportion of patients with airway secretion scores of 3 or 4

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

Assessment of Comfort Management

Proportion of patients with more than one gasp (≥ 2)

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

Assessment of Communication with Relatives

Proportion of relatives who had at least three meetings with ICU caregivers

Time frame: From inclusion to date of ICU discharge, assessed up to 28 days

Assessment of Communication with Relatives

Proportion of meetings conducted jointly by a senior physician and a nurse

Time frame: From inclusion to date of ICU discharge, assessed up to 28 days

Assessment of Communication with Relatives

Proportion of relatives who had a meeting with a psychologist

Time frame: From inclusion to date of ICU discharge, assessed up to 28 days

Assessment of Conflicts

Level of conflicts between ICU healthcare givers and relatives, as rated on a 0-10 Likert scale. A higher score indicates a more intense conflict.

Time frame: From inclusion to date of ICU discharge, assessed up to 28 days

Assessment of Conflicts

Level of conflicts between among healthcare professionals, as rated on a 0-10 Likert scale. A higher score indicates a more intense conflict.

Time frame: From inclusion to date of ICU discharge, assessed up to 28 days

Assessment of Conflicts

Level of conflicts between among relatives, as rated on a 0-10 Likert scale. A higher score indicates a more intense conflict.

Time frame: From inclusion to date of ICU discharge, assessed up to 28 days

Assessment of Quality of Dying by Relatives

Quality of Dying and Death questionnaire (QODD-1) assessed 1 month after death, as rated on a 0-10 Likert scale. Higher scores correlate with a more satisfactory level of care.

Time frame: From inclusion to 1 month after death of the patient

Anxiety and Depression in Relatives

Hospital Anxiety and Depression Scale (HADS) assessed 1, 3, 6, and 12 months after death. HADS min = 0, max = 42; Higher scores correlate with increased risk of anxiety and depression.

Time frame: From inclusion to 1, 3, 6, and 12 months after the death of the patient

Post-Traumatic Stress Disorders in Relatives

Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) assessed 1, 3, 6, and 12 months after death. PCL-5 min = 0, max = 80; Higher scores correlate with increased risk of posttraumatic stress.

Time frame: From inclusion to 1, 3, 6, and 12 months after the death of the patient

Prolonged Grief in Relatives

Prolonged Grief Disorder scale (PG-13) assessed 12 months after death. PG-13 min = 4, max = 48; Higher scores correlate with increased risk of prolonged grief.

Time frame: From inclusion to 12 months after the death of the patient

Assessment of Quality of Dying by Healthcare Professionals

Quality of Dying and Death questionnaire (QODD-1), as rated on a 0-10 Likert scale. Higher scores correlate with a more satisfactory level of care.

Time frame: After the death of the patient, assessed up to 28 days

Psychological Impact on Healthcare Professionals

Measure of Moral Distress for Healthcare Professionals (MMD-HP). MMD-HP min = 0, max = 432; Higher scores correlate with increased risk of moral distress.

Time frame: After the death of the patient, assessed up to 28 days

Impact on ICU Organization and Staff

Perceived Stressors in Intensive Care Units (PS-ICU) assessing burnout at the end of the inclusion period. PS-ICU min = 0, max = 104; Higher scores correlate with increased risk of stress at work.

Time frame: Up to 2 years

Impact on ICU Organization and Staff

Maslach Burnout Inventory (MBI) assessing burnout at the end of the inclusion period. MBI min = 0, max = 132; Higher scores correlate with increased risk of burnout.

Time frame: Up to 2 years

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts