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Effect and safety of salivary gland botulinum toxin injection in preventing ventilator-associated pneumonia in critically ill neurological patients: a single-center randomized controlled clinical study

Effect and safety of salivary gland botulinum toxin injection in preventing ventilator-associated pneumonia in critically ill neurological patients: a single-center randomized controlled clinical study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107872
Enrollment
Unknown
Registered
2025-08-20
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical disorders of nervous system

Interventions

Intervention group:Ultrasound-guided single botulinum toxin injection into the parotid and submandibular glands
Control group:Core airway prevention measures

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patients with severe neuropathy aged >=18 years old; 2. NIHSS>=11 points, or GCS=48 hours; 4. The patient's family or legal representative signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Invasive mechanical ventilation support time = 24 hours at screening; 2. Novel coronavirus infection; 3. Extremely critical condition, vital sign fluctuations that cannot be stabilized by drugs and other treatments; 4. Severe bleeding tendency and coagulation mechanism disorders; 5. Serious and uncontrolled cardiopulmonary organic lesions before the onset of the disease, including pulmonary hypertension, moderate to severe heart failure, tuberculosis, lung infection, lung abscess, moderate/severe/very severe chronic obstructive pulmonary disease. 6. Those whose head and facial anatomical structures cannot be positioned by B-ultrasound due to structural disorders caused by past or existing medical history; 7. Those who have received head and neck radiotherapy or salivary gland surgery; 8. Those with an increased risk of infection due to past or existing medical history and treatment, including congenital/acquired immunodeficiency, long-term use of immunosuppressive drugs, post-organ transplantation, malignant tumors, and agranulocytosis; 9. Patients who have participated in other interventional clinical studies.

Design outcomes

Primary

MeasureTime frame
Incidence of ventilator-associated pneumonia;

Countries

China

Contacts

Public ContactYi Li

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

1024254327@qq.com+86 150 1876 1512

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026