An observational study in Stroke and Tracheotomy Patients, sponsored by The Second Affiliated Hospital of Kunming Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-11.
Sponsored by The Second Affiliated Hospital of Kunming Medical University · Observational
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 717 is above the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →The Second Affiliated Hospital of Kunming Medical University is the lead sponsor of 17 studies on the registry; 11 are open to participants now.
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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.
Exclusion Criteria:
Coagulation disorders:
Active uncontrolled infection at admission (e.g., pneumonia, urinary tract infection, intracranial infection, sepsis) defined by:
High altitude stroke patients with tracheotomy.
Other: High altitude
Stroke patients with moderate altitude combined with tracheotomy.
Other: Low altitude group
Low altitude stroke patients with tracheotomy.
Other: Medium altitude
Altitude above 3500 meters.
Altitude between 3500 meters and 1500 meters.
Altitude below 1500 meters.
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.
Time frame: Through study completion, an average of 1 year.
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The Second Affiliated Hospital of Kunming Medical University