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Electrical stimulation for the prevention of pulmonary infection complications in patients with severe acute brain injury: A multicenter randomized controlled clinical trial protocol

Electrical stimulation for the prevention of pulmonary infection complications in patients with severe acute brain injury: A multicenter randomized controlled clinical trial protocol

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000038
Enrollment
Unknown
Registered
2026-01-09
Start date
2026-03-06
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

pulmonary infection

Interventions

control group:Only undergo conventional Western medical treatment without electroacupuncture intervention.
Electroacupuncture intervention group:Undergo basic Western medical treatment and receive electroacupuncture intervention.

Sponsors

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1)Age 18 to 75 years, gender unspecified; 2) Confirmed by CT or MRI as traumatic brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, or ischemic stroke; 3) Meets criteria for severe acute brain injury (GCS =12 or NIHSS =15); 4) Time from onset to enrollment =24 hours; 5) Informed consent signed by the subject or legal representative.

Exclusion criteria

Exclusion criteria: 1. Patients who have been diagnosed with pulmonary infection before admission; 2. Coma caused by tumors, infectious diseases, cardiac arrest, or hypoglycemia; 3. Patients who have undergone endotracheal intubation, subglottic secretion drainage, or mechanical ventilation via tracheostomy; 4. Patients with pulmonary tuberculosis, pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), bronchial asthma, chronic bronchitis, or interstitial lung diseases; 5. Patients with severe heart, liver, or kidney failure, malignant tumors, or other autoimmune diseases; 6. Patients with a history of severe infection or sepsis within the past month; 7. Patients who have used antibiotics or glucocorticoids within the past week; 8. Patients with lower limb trauma or deep vein thrombosis; skin infection, ulcer, or severe coagulation disorders at the acupuncture site; 9. Patients with implanted pacemakers or other active cardiac electronic devices that may be affected by electroacupuncture; 10. Patients participating in other clinical studies; 11. Lactating or pregnant women.

Design outcomes

Primary

MeasureTime frame
The incidence rate of pulmonary infection within 7 days.;

Secondary

MeasureTime frame
Time of Infection (days);Percentage of new antibiotic use within 7 days / Duration;The proportion requiring mechanical ventilation within 7 days.;ICU/Hospitalization Days;Neurological evaluation;Inflammation/Immune-Related Laboratory Indicators;

Countries

China

Contacts

Public ContactGuiwei Li

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

li-guiwei@163.com13902111226

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Apr 4, 2026