Currently submitted to: JMIR Research Protocols
Date Submitted: Jan 23, 2026
Open Peer Review Period: Jan 26, 2026 - Mar 23, 2026
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A Protocol for a Multicenter Cohort Study on Extubation Success After Tracheotomy in Stroke Patients at Different Altitudes: The ESTATE Study
ABSTRACT
Background:
Stroke represents a leading cause of global disability and mortality. In acute stroke patients, tracheotomy is often required for survival during the critical phase; however, weaning from the tracheostomy tube remains a major challenge in the recovery period. Prolonged dependence on the tube considerably impairs patients' quality of life. Previous research indicates that multiple environmental factors—including oxygen concentration, air humidity, and ultraviolet radiation—can influence cardiopulmonary function and airway adaptability. Moreover, high-altitude environments are known to alter hemoglobin oxygen-carrying capacity and induce adaptive genetic polymorphisms. Based on these observations, we hypothesize that residents living at different altitudes may demonstrate varying success rates of tracheostomy tube removal.
Objective:
This study aims to investigate whether altitude of residence affects extubation success rates by modulating adaptive mechanisms related to hemoglobin oxygen affinity and genetic factors (EPAS1/EGLN1). We further aim to develop a predictive model integrating environmental factors, genetic polymorphisms, and clinical data for estimating extubation success.
Methods:
The "Extubation Success After Tracheotomy in Stroke Patients at different Altitudes" (ESTATE) study is a prospective, multi-center cohort study (August 2025–December 2028). This initiative aims to enroll 900 tracheotomized stroke patients from Chinese regions stratified by altitude. After screening against strict criteria, participants will receive baseline assessments (demographics, clinical scales, hematological tests). All will undergo standardized rehabilitation, with outcomes—including extubation status and quality of life—assessed at discharge and at 1, 3, 6, 9, and 12 months post-discharge.
Results:
Initiated in August, 2025, this study has enrolled 25 participants to date. Recruitment will continue through 2027, with final follow-up and data analysis to be completed in 2028. The main findings are expected to Our research team aims to conduct an in-depth investigation into the association between successful extubation and the biological and genetic adaptations resulting from long-term residence at different altitudes in tracheotomized stroke patients. This study seeks to elucidate the underlying molecular mechanisms of the exposure-response relationship, with the ultimate objective of providing novel therapeutic strategies and a solid theoretical basis for clinical practice.be submitted for publication in 2029.
Conclusions:
Our research team aims to conduct an in-depth investigation into the association between successful extubation and the biological and genetic adaptations resulting from long-term residence at different altitudes in tracheotomized stroke patients. This study seeks to elucidate the underlying molecular mechanisms of the exposure-response relationship, with the ultimate objective of providing novel therapeutic strategies and a solid theoretical basis for clinical practice. Clinical Trial: ClinicalTrials.gov (United States) NCT07014501; https://clinicaltrials.gov/ct2/show/ NCT07014501
Citation
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