Withholding of Life-sustaining Treatment and Quality of Life After Severe Acute Brain Injury: Qualitative Analysis and Ethical Issues

Recruiting

• Conditions: Post ICU; Quality of Life; Brain Injuries
• Interventions: Other: Recording data from the ICU stay and the post-ICU follow-up.

• Registration Number: NCT06523127
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Withdrawal of life-sustaining treatment affects 10-15% of ICU patients, including those with severe acute brain injury, whose care appears futile in terms of prognosis based on clinical and paraclinical data, expected quality of life, patient preferences, age, or reduced quality of life.

There are few studies on withholding treatment compared with withdrawing treatment, and even fewer on survivors after a decision to withhold treatment.

Quality of life is defined by WHO as "an individual's perception of his or her position in life in the context of the culture and value systems in which he or she lives and in relation to his or her goals, expectations, standards and concerns". The relationship between quality of life and neurological outcome after severe acute brain injury is controversial and therefore difficult to predict.

That's why the investigators question the legitimacy of making decisions to withhold treatment from patients with severe acute brain injury based on their expected quality of life, when this prediction is uncertain.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-03
• Status Verified: 2024-07
• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-22
• Last Update Submitted: 2024-07-22
• Study First Posted: 2024-07-26
• Last Update Posted: 2024-07-26
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Patients:

• with severe acute brain injury (TBI, stroke, central nervous system infection).
• admitted in the neurocritical care unit in 2022.
• followed up 24 months after ICU between 15th April 2024 and 31st August 2024.

Exclusion Criteria

Patients:

• death in 2024,
• refusal by patient or relative.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with severe acute brain injury and with withholding of life-sustaining treatment	Recording data from the ICU stay and the post-ICU follow-up.	Assessment of quality of life in patients with severe acute brain injury based on the audio recording during post-ICU follow-up.
Patients with severe acute brain injury and without withholding of life-sustaining treatment	Recording data from the ICU stay and the post-ICU follow-up.	Assessment of quality of life in patients with severe acute brain injury based on the audio recording during post-ICU follow-up.

Primary Outcome Measures

Name	Time	Method
Interpretative Phenomenological Analysis	24 months after ICU discharge	Qualitative analysis of the quality of life in patients with severe acute brain injury and with withholding of life-sustaining treatment

Secondary Outcome Measures

Name	Time	Method
International survey among neurointensivists from ANARLF network - questionnaires	Month : 3	Comparison of the number of decisions of withholding treatment in the clinical cases versus real life
International survey among neurointensivists from ANARLF network - follow-up	Month : 3	Comparison of the predicted neurological outcome and quality of life by neurointensivists versus the real neurological outcome and quality of life assessed at the post-ICU follow-up.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Saint Etienne; 🇫🇷 Saint Etienne, France