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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Brain Injuries; Post ICU
• Intervention / Treatment: Other: Recording data from the ICU stay and the post-ICU follow-up.

• Study Type: Observational
• Enrollment (Estimated): 14

Contacts and Locations

• Study Contact: Name: Marie DAKENG, resident; Phone Number: +33 (0)4 77 82 83 29; Email: mcgperret@gmail.com
• Study Contact Backup: Name: Nory ELHADJENE, MD; Phone Number: +33 (0)4 77 82 83 29; Email: Nory.ELHADJENE@chu-st-etienne.fr

Study Locations

• France
  • Saint Etienne, France, 42055
    • Recruiting
    • Centre Hospitalier Universitaire de Saint Etienne
    • Sub-Investigator: Nory ELHADJENE, MD
    • Contact: Marie DAKENG, resident; Phone Number: +33 (0)4 77 82 83 29; Email: mcgperret@gmail.com
    • Principal Investigator: Marie DAKENG, resident
    • Sub-Investigator: Jérôme MOREL, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute brain injury admitted to intensive care in 2022 will be included.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with severe acute brain injury and with withholding of life-sustaining treatment; Assessment of quality of life in patients with severe acute brain injury based on the audio recording during post-ICU follow-up.	Other: Recording data from the ICU stay and the post-ICU follow-up.; Record analysis of the post-ICU follow-up with the Interpretative Phenomenological Analysis
Patients with severe acute brain injury and without withholding of life-sustaining treatment; Assessment of quality of life in patients with severe acute brain injury based on the audio recording during post-ICU follow-up.	Other: Recording data from the ICU stay and the post-ICU follow-up.; Record analysis of the post-ICU follow-up with the Interpretative Phenomenological Analysis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International survey among neurointensivists from ANARLF network - questionnaires	Comparison of the number of decisions of withholding treatment in the clinical cases versus real life	Month : 3
International survey among neurointensivists from ANARLF network - follow-up	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.	Month : 3

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Marie DAKENG, resident, CHU Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 26, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Withholding of life-sustaining treatments; Withdrawal of life-sustaining treatment; Severe acute brain injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: IRBN672024/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No