💬In plain words
What the trial is, and whether it could suit you
Patients with brain injuries caused by various reasons often need tracheotomy to improve breathing, but this procedure can cause the air to lose its nasal regulation, increase the risk of lung infections, and reduce their quality of life. Tracheal extubation is crucial for patient recovery. Environmental factors in high-altitude areas have a significant impact on human cardiovascular function, including changes in blood oxygen caused by low oxygen environments and cardiovascular adaptability of long-term residents. There is limited research on the impact of high altitude on the success rate of tracheal extubation in brain injury. The research team conducted a retrospective study on 501 patients who underwent tracheotomy at the Second Affiliated Hospital of Kunming Medical University and found that high GCS scores and hemoglobin concentrations were beneficial for extubation. The increase
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Age between 18 and 75 years.
2. Hospitalized patients in the rehabilitation department with acute non-traumatic ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage requiring tracheostomy.
3. Hemodynamic stability: Systolic blood pressure maintained between 90-160 mmHg, diastolic blood pressure between 60-100 mmHg, respiratory rate between 12-30 breaths/min, heart rate between 60-120 beats/min, body temperature between 36.5°C-38.5°C, and arterial oxygen saturation (SaO₂) consistently \>90% at admission and prior to tracheostomy.
4. Glasgow Coma Scale (GCS) score of 5-15 at assessment.
5. Tracheostomy performed within 24-72 hours after stroke onset.
6. Peripheral blood hemoglobin concentration at admission within specified ranges (male: 120-180 g/L; female: 110-160 g/L).
7. Signed informed consent provided by the patient or legal guardian.
Exclusion Criteria:
1. History of severe cardiopulmonary dysfunction (e.g., chronic obstructive pulmonary disease, cor pulmonale, coronary artery disease, cardiomyopathy) with New York Heart Association (NYHA) functional class III or IV, or recent (within 6 months) acute myocardial infarction or unstable angina.
2. Diagnosis of advanced malignancy (life expectancy \<6 months) with ongoing chemotherapy, radiotherapy, or palliative care.
3. Severe hepatic or renal insufficiency (e.g., decompensated cirrhosis, chronic renal failure requiring long-term dialysis).
4. Uncontrolled endocrine disorders (e.g., thyrotoxic crisis, myxedema coma, diabetic ketoacidosis, hyperosmolar hyperglycemic state).
5. Coagulation disorders:
* Congenital or acquired coagulopathies (e.g., hemophilia, vitamin K deficiency, coagulation factor deficiency due to severe liver disease, antiphospholipid syndrome).
* Active anticoagulation therapy (e.g., warfarin with INR \>3.0, heparin with APTT exceeding twice the upper limit of normal) unadjustable to a safe range within 72 hours.
6. Major surgery within 3 months (e.g., cardiac, abdominal, or orthopedic surgery).
7. Severe chest trauma (e.g., multiple rib fractures, pneumohemothorax) or abdominal trauma (e.g., liver/spleen rupture, intestinal perforation) within 1 month prior to stroke onset, with incomplete recovery.
8. Active uncontrolled infection at admission (e.g., pneumonia, urinary tract infection, intracranial infection, sepsis) defined by:
* Temperature \>38.5°C persisting \>24 hours.
* Elevated white blood cell count, increased neutrophil percentage, and clinical signs of infection.
* Positive bacterial cultures (blood, sputum, urine).
9. Recent (within 1 week) exposure to infectious diseases (e.g., travel to epidemic areas, contact with confirmed cases) with suspected latent or active infection.
10. History of neurodegenerative diseases (e.g., Parkinson's disease, Alzheimer's disease) or motor neuron disorders (e.g., amyotrophic lateral sclerosis).
11. Congenital neurological developmental abnormalities (e.g., hydrocephalus, cerebral palsy).
12. Severe uncontrolled psychiatric disorders (e.g., schizophrenia, major depressive disorder, bipolar disorder) impairing daily function or treatment adherence.
13. Cognitive impairment (e.g., dementia) with Mini-Mental State Examination (MMSE) score \<10.
14. Pregnancy or lactation.
15. Hypersensitivity or contraindications to study-related drugs or procedures (e.g., allergy to tracheostomy tube materials, antibiotic allergies without alternatives).
16. Inability to complete follow-up or required tests (e.g., geographical barriers, unreliable contact information).
17. Non-compliance of the patient or family members with the study protocol.
18. Failure to obtain informed consent.
19. Participation in other interventional clinical trials.