Altitude, genes, and hemoglobin: effects on removing a tracheotomy tube after stroke

Study on the Correlation Mechanism and Application of Genetic Susceptibility, Hemoglobin Adaptation Changes, and Extubation Success Rate in Stroke Patients With Tracheotomy at Different Altitudes

This study tests whether altitude, genetic differences, and changes in hemoglobin affect the chance of successfully removing a tracheotomy tube in adults recovering from stroke.

Quick facts

• Study type: Observational
• Enrollment: 717 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Second Affiliated Hospital of Kunming Medical University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Kunming, Yunnan)
• Trial ID: NCT07014501 on ClinicalTrials.gov

What this trial studies

This is an observational study comparing stroke patients with tracheotomies who live at high, medium, and low altitudes to see how genetic susceptibility and hemoglobin adaptation relate to extubation success. Researchers will collect clinical data, hemoglobin measurements, and genetic markers and compare extubation outcomes across altitude groups, using the site’s retrospective findings as background. Eligible patients are adults 18–75 with acute non‑traumatic stroke who had a tracheostomy within 24–72 hours and are hemodynamically stable. The goal is to identify patterns that might help predict which patients are most likely to be successfully extubated at different altitudes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–75 hospitalized for acute non‑traumatic ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage who required tracheostomy within 24–72 hours, meet the study’s hemodynamic and hemoglobin criteria, and can provide consent.

Not a fit: Patients with severe cardiopulmonary dysfunction, unstable vital signs, traumatic brain injury, hemoglobin outside the specified ranges, those outside the 18–75 age window, or those unable to consent are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the findings could help clinicians predict extubation success and personalize timing and care for stroke patients living at different altitudes, potentially reducing complications and improving recovery.

How similar studies have performed: A retrospective analysis of 501 patients at the same center suggested higher GCS scores and hemoglobin were linked to extubation success, but prospective or multi‑altitude evidence remains limited.

Eligibility criteria

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.

Where this trial is running

Kunming, Yunnan

• Electroencephalography — Kunming, Yunnan, China (Recruiting)

Study contacts

• Study coordinator: liqing Yao

Conditions Stroke; Tracheotomy Patients