Detecting risky behaviors in agitated, bedridden neurosurgery patients
Detection of Risk Behaviors: Pilot Observational Study With Bedridden and Agitated Patients.
This project will try to detect and record risky behaviors in hospitalized bedridden patients who are agitated or confused so clinicians can understand how often and what types occur.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT05522647 on ClinicalTrials.gov |
What this trial studies
This is a pilot observational project conducted in the neurosurgery department at CHU Clermont-Ferrand that will continuously observe bedridden patients who display agitation or confusion. Eligible patients are those hospitalized at least nine days with neurological or cognitive disorders leading to agitation, and participation requires patient or trusted-person consent. Observers will document the nature and frequency of risk behaviors and related events such as use of physical or chemical restraints, falls, and required additional examinations. The collected descriptive data aim to clarify patterns of endangerment for patients and emotional and economic impacts for caregivers and the hospital.
Who should consider this trial
Good fit: Ideal candidates are bedridden neurosurgery inpatients at CHU Clermont-Ferrand with neurological or cognitive disorders causing agitation or confusion who will remain hospitalized for at least nine days and who (or whose trusted person) can provide consent.
Not a fit: Patients with acute or transient somatic agitation (for example from pain or metabolic disturbance), those under guardianship/curatorship, pregnant or breastfeeding women, or anyone who refuses participation are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, the findings could help staff identify common risky behaviors and timing so they can reduce falls, unnecessary restraints, and related harms.
How similar studies have performed: While observational work on falls and agitation exists, detailed bedside characterization of risk behaviors specifically in bedridden neurosurgery patients is relatively underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Hospitalized in the Neurosurgery Department of the Clermont-Ferrand University Hospital * Suffering from neurological and/or cognitive disorders leading to agitation and/or confusion * Affiliation to a social security system * Hospitalization in the department for at least 9 days * Acceptance by the patient and/or trusted person capable of giving informed consent to participate in the research Exclusion Criteria: * Acute or transient agitation phase of somatic origin (bladder globe, pain, ionic disorder...) * Patient under guardianship, curatorship or safeguard of justice * Pregnant and breastfeeding women * Refusal to participate
Where this trial is running
Clermont-Ferrand
- CHU clermont-ferrand — Clermont-Ferrand, France (Recruiting)
Study contacts
- Principal investigator: Charlène DUBOIS — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.