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

NCT06523127 | Recruiting

• 1 other identifier: IRBN672024/CHUSTE
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Brain Injuries; Post ICU

Keywords

Quality of life; Withholding of life-sustaining treatments; Withdrawal of life-sustaining treatment; Severe acute brain injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• International survey among neurointensivists from ANARLF network - questionnaires

  Month : 3

• International survey among neurointensivists from ANARLF network - follow-up

  Month : 3

Study Arms (2)

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.

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.

Interventions

Recording data from the ICU stay and the post-ICU follow-up. OTHER

Record analysis of the post-ICU follow-up with the Interpretative Phenomenological Analysis

Patients with severe acute brain injury and with withholding of life-sustaining treatment; Patients with severe acute brain injury and without withholding of life-sustaining treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Centre Hospitalier Universitaire de Saint Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Marie DAKENG, resident

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie DAKENG, resident

CONTACT

(0)4 77 82 83 29; mcgperret@gmail.com

Nory ELHADJENE, MD

CONTACT

(0)4 77 82 83 29; Nory.ELHADJENE@chu-st-etienne.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: June 3, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)