RecruitingNot Applicable

Circadian Rhythmicity During Coma Awakening

France90 participantsStarted 2024-12-02

Plain-language summary

Acute brain injury is a major cause of admission to intensive care units, as well as of mortality and morbidity, worldwide and for all age groups. With most patients surviving these injuries thanks to recent medical advances, society is facing not only the growing burden of disability, but above all the ethical issues involved in withdrawal of life-sustaining therapies (WSLT). To resolve this dilemma, effective treatment would be necessary, but this is hampered by our limited knowledge of the pathophysiological mechanisms of the natural history of coma, from onset to recovery. A more systematic description of coma awakening using a multimodal battery in intensive care unit patients would enable us to refine the awakening and re-emergence of consciousness and define appropriate biomarkers for selecting candidates in interventional studies. The investigators hypothesize that the current postulate of successive stages (i.e. from one clinical class to the next) of coma recovery is incomplete, as it does not take into account the rhythmic nature of wakefulness. The investigators propose that the best correlate of the natural history of coma recovery is a gradual shift from the loss of physiological cycles to a circadian rhythmicity of arousal indices (behavioural and neurophysiological) and a wide amplitude of metric fluctuations in assessing content richness.

Who can participate

Age range17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Group 1 * Admission to the Neurological Intensive Care Unit * Initial disorder of consciousness (GCS \< 8) or initial brain lesion (on CT or MRI) requiring intubation and sedation during management (for upper airway protection or due to coma) * Intubated patient under mechanical ventilation wwith no response to simple commands * Weaning from sedation : acquired / possible within 7 days of inclusion in the absence of new complications * Severity of clinical or morphological impairment leading to risk of persistent disturbance of consciousness * Sedation discontinued or able to be discontinued within 3 month of initial management of the disorder of consciousness or brain injury * Effective treatment of the cause of admission without risk of short-term recurrence * Patient aged 17 or over * Urinary catheter in place at the time of inclusion and to remain in place until Visit N°1 * Presence of relatives able to sign consent or of the minor's legal representative Group 2 * Admission to the Neurological Intensive Care Unit or the Neurological Continuing Care Unit * Absence of severe disorder of consciousness but possibility of minimal alteration of the initial Glasgow score (GCS between 9 and 15) with no time limit, with a stratification of three consecutive patient populations distinguished by the initial neurological alteration: * GCS = 15 * GCS \< 15 by predominance of an initial defect in responses to simple or complex commands obtained by motor or …

What they're measuring

Consciousness outcome

Timeframe: 2, 3, 4,6 months post injury

Trial details

NCT IDNCT06245434

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-02

Contact for this trial

GOBERT FLORENT, M.D. Ph.D.

0472681296 florent.gobert01@chu-lyon.fr