Disorders of consciousness
Conditions
Interventions
Intervene Group:Enhanced oral care
Sponsors
Affiliated Hospital of Stomatology, Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 or older, any gender. 2. Coma or disorders of consciousness (DoC) caused by stroke, traumatic brain injury, hypoxic-ischemic brain injury, or other acquired brain injuries, clinically assessed as coma, unresponsive wakefulness syndrome/vegetative state, minimally conscious state, or emerging from minimally conscious state. 3. Unable to perform oral hygiene independently and requires nursing staff to provide oral care. 4. Expected to receive care in the study ward for at least 4 weeks, or the clinical team believes there is a high likelihood of completing at least the T2 assessment. 5. Vital signs relatively stable before the first study care session, oral examination and basic care can be safely performed without forcefully opening the mouth. 6. Legal representative or guardian voluntarily signs written informed consent; the patient does not show clear opposition within their level of understanding.
Exclusion criteria
Exclusion criteria: 1. Known allergy to chlorhexidine or a history of severe allergic reactions related to chlorhexidine. 2. Active major oral bleeding, severe oral mucositis or ulcers, severe maxillofacial trauma, recent major oral surgery, or the investigator deems toothbrushing or sampling too risky. 3. Severe jaw clenching making care impossible without increasing the risk of injury. 4. Expected death, life support withdrawal, or transfer within 48 hours. 5. Currently participating in another study that could significantly affect the oral microbiome, or has used off-protocol chlorhexidine or other potent oral antiseptics and can't stop using them. 6. The principal investigator believes there are other reasons the person shouldn't be enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in centered log-ratio abundance of the prespecified respiratory opportunistic pathogen composite; | — |
Secondary
| Measure | Time frame |
|---|---|
| Beta diversity of the oral microbiome;Alpha diversity of the oral microbiome; | — |
Countries
China
Contacts
Public ContactRen Xiaoyu
Affiliated Hospital of Stomatology, Anhui Medical University
Outcome results
None listed