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NCT07014501Recruiting

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

Source: ClinicalTrials.gov · Last updated 11 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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 in hemoglobin concentration among high-altitude residents may be an adaptive response to hypoxia, and the research team speculates that this may become a protective factor for successful extubation. However, some argue that altitude sickness and adaptive genetic changes may counteract each other. Simonson's team found that the decline of hemoglobin concentration in Tibetans was related to specific gene expression, indicating that the genetic adaptability of high altitude residents had a unique relationship with hemoglobin concentration. Therefore, the research team speculates that people living in highlands for a long time are more adaptable to hypoxic environments than those living in lowlands. Under severe stress (hypoxia), people living in highlands for a long time may have lower sensitivity to pulmonary blood flow redistribution or oxygen delivery compared to those living in lowlands. This study is a multicenter observational study, with sub centers listed as follows: Jiangchuan District People's Hospital, Huaning County People's Hospital, Baoshan Second People's Hospital, Huize County People's Hospital, Mengla County People's Hospital, Tonghai County People's Hospital, Jinghong City First People's Hospital, Xuanwei City First People's Hospital, Qiubei County People's Hospital, Fengqing County People's Hospital, Weixin County People's Hospital, Yulong County People's Hospital, Yanshan County People's Hospital, Xundian County People's Hospital, Shizong County People's Hospital, Luxi County People's Hospital, Yunnan Province Northeast Yunnan Central Hospital, Luoping County People's Hospital, Xinping County General Hospital, Suijiang County People's Hospital, Nanhua County Hospital, Guangnan County People's Hospital County People's Hospital, Jianshui County People's Hospital, Simao District People's Hospital of Pu'er City, Funing County People's Hospital, Xinping County Traditional Chinese Medicine Hospital Xundian County First People's Hospital and Jingdong County People's Hospital.

Status (registry)
Recruiting
Study type
Observational
Enrollment
717 (estimated)
First submitted
19 May 2025
Start date
1 Jan 2025
Primary completion date
31 Dec 2027
Lead sponsor
The Second Affiliated Hospital of Kunming Medical University
Diseases
Stroke
NCT number
NCT07014501

What you commit to

  • Study type: Observational
  • Planned participants: 717
  • From 1 Jan 2025 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.
  • Diagnosis of advanced malignancy (life expectancy \<6 months) with ongoing chemotherapy, radiotherapy, or palliative care.
  • Severe hepatic or renal insufficiency (e.g., decompensated cirrhosis, chronic renal failure requiring long-term dialysis).
  • Uncontrolled endocrine disorders (e.g., thyrotoxic crisis, myxedema coma, diabetic ketoacidosis, hyperosmolar hyperglycemic state).
  • Major surgery within 3 months (e.g., cardiac, abdominal, or orthopedic surgery).
  • Recent (within 1 week) exposure to infectious diseases (e.g., travel to epidemic areas, contact with confirmed cases) with suspected latent or active infection.
  • History of neurodegenerative diseases (e.g., Parkinson's disease, Alzheimer's disease) or motor neuron disorders (e.g., amyotrophic lateral sclerosis).
  • Severe uncontrolled psychiatric disorders (e.g., schizophrenia, major depressive disorder, bipolar disorder) impairing daily function or treatment adherence.
  • Cognitive impairment (e.g., dementia) with Mini-Mental State Examination (MMSE) score \<10.
  • Hypersensitivity or contraindications to study-related drugs or procedures (e.g., allergy to tracheostomy tube materials, antibiotic allergies without alternatives).
  • Failure to obtain informed consent.

Lab values

  • 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.
  • 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).

Other

  • Congenital neurological developmental abnormalities (e.g., hydrocephalus, cerebral palsy).
  • Pregnancy or lactation.
  • Inability to complete follow-up or required tests (e.g., geographical barriers, unreliable contact information).
  • Non-compliance of the patient or family members with the study protocol.
  • Participation in other interventional clinical trials.

Who the study is looking for

  • Age between 18 and 75 years.
  • Hospitalized patients in the rehabilitation department with acute non-traumatic ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage requiring tracheostomy.
  • 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.
  • Glasgow Coma Scale (GCS) score of 5-15 at assessment.
  • Tracheostomy performed within 24-72 hours after stroke onset.
  • Peripheral blood hemoglobin concentration at admission within specified ranges (male: 120-180 g/L; female: 110-160 g/L).
  • Signed informed consent provided by the patient or legal guardian.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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KunmingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.