StrokeNCT07014501
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
An observational study of Stroke and Tracheotomy Patients, run by The Second Affiliated Hospital of Kunming Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Tracheotomy Patients
- What is being tested?
- High altitude, Medium altitude and Low altitude group
- How many people
- 717 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 29 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study enrolls hospitalized patients aged 18-75 with acute non-traumatic ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage requiring tracheostomy, stratified by long-term residence altitude: high (>3500m), medium (1500-3500m), and low (<1500m). Target sample: 717 participants (20% attrition). Participants will be recruited from the Rehabilitation Medicine Department of the Second Affiliated Hospital of Kunming Medical University and 27 participating centers. Ethics-approved with written consent and data confidentiality.
Who may be able to join
- 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.
Who cannot join
- 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).
- Coagulation disorders:
- Congenital or acquired coagulopathies (e.g., hemophilia, vitamin K deficiency, coagulation factor deficiency due to severe liver disease, antiphospholipid syndrome).
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- 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.
- Major surgery within 3 months (e.g., cardiac, abdominal, or orthopedic surgery).
- 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.
- 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).
- 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).
- Congenital neurological developmental abnormalities (e.g., hydrocephalus, cerebral palsy).
- 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.
- Pregnancy or lactation.
- Hypersensitivity or contraindications to study-related drugs or procedures (e.g., allergy to tracheostomy tube materials, antibiotic allergies without alternatives).
- 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.
- Failure to obtain informed consent.
- Participation in other interventional clinical trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Electroencephalography
Kunming, Yunnan
Liqing Yao, +8613529202383, yaoliqing98731@163.com
About this study
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.
- Conditions
- Stroke, Tracheotomy Patients
- Being tested
- High altitude, Medium altitude, Low altitude group
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High altitudeOther
Altitude above 3500 meters.
Medium altitudeOther
Altitude between 3500 meters and 1500 meters.
Low altitude groupOther
Altitude below 1500 meters.
| Study group | Role | What they receive |
|---|---|---|
| High altitude group | High altitude stroke patients with tracheotomy. Receives: Other: High altitude | |
| Medium altitude group | Stroke patients with moderate altitude combined with tracheotomy. Receives: Other: Low altitude group | |
| Low altitude group | Low altitude stroke patients with tracheotomy. Receives: Other: Medium altitude |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracheostomy extubation
The outcome measure is the success of tracheostomy tube extubation in stroke patients. Successful extubation is defined as extubation of the tracheal tube as planned and not reintubated during subsequent treatment, and survival within 7 days of extubation.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion29 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 717 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liqing Yao, The Second Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014501
- Sponsor's protocol ID
- Shen-PJ-Ke-2025-94
- Status last verified
- Jun 2025
- First submitted
- 19 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07014501
- Acronym / sponsor ID
- Shen-PJ-Ke-2025-94
- Conditions
- Stroke, Tracheotomy Patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 717 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 29 May 2028 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High altitude group | – | Other: High altitudeHigh altitude stroke patients with tracheotomy. |
| Medium altitude group | – | Other: Low altitude groupStroke patients with moderate altitude combined with tracheotomy. |
| Low altitude group | – | Other: Medium altitudeLow altitude stroke patients with tracheotomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study enrolls hospitalized patients aged 18-75 with acute non-traumatic ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage requiring tracheostomy, stratified by long-term residence altitude: high (>3500m), medium (1500-3500m), and low (<1500m). Target sample: 717 participants (20% attrition). Participants will be recruited from the Rehabilitation Medicine Department of the Second Affiliated Hospital of Kunming Medical University and 27 participating centers. Ethics-approved with written consent and data confidentiality.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (24 listed)
- 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).
- Coagulation disorders:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High altitudeAltitude above 3500 meters. | Other | High altitude group |
| Medium altitudeAltitude between 3500 meters and 1500 meters. | Other | Low altitude group |
| Low altitude groupAltitude below 1500 meters. | Other | Medium altitude group |
Primary outcome
Tracheostomy extubation
Time frame: Through study completion, an average of 1 year.
The outcome measure is the success of tracheostomy tube extubation in stroke patients. Successful extubation is defined as extubation of the tracheal tube as planned and not reintubated during subsequent treatment, and survival within 7 days of extubation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Tracheotomy Patients, run by The Second Affiliated Hospital of Kunming Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact liqing Yao (+8613529202383, yaoliqing98731@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tracheostomy extubation (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.