The Affiliated Hospital of Qingdao University
Qingdao, Shangdong, 266000, China
NCT Number: NCT07555990
Systemic Arterial Gas Embolism (SAGE) is a rare but fatal complication characterized by the accidental entry of gas into the left heart system, which then travels through the systemic arterial circulation, leading to embolisms in critical organs such as the brain and heart. Compared to venous gas embolism, SAGE can cause catastrophic outcomes, such as acute cerebral infarction, myocardial infarction, or even death, with only a minimal volume of gas. Furthermore, recent studies have found that even subclinical micro-emboli, while not causing typical infarction symptoms, may activate inflammatory responses and the complement system, leading to long-term risks such as postoperative cognitive dysfunction. The potential impact of SAGE is far broader and more severe than previously recognized.
Bronchoscopy is a cornerstone in the diagnosis and treatment of respiratory diseases, with increasingly widespread applications. Theoretically, procedures involving the lungs-as gas-containing hollow organs-carry the highest risk of SAGE, especially during invasive interventions. Although the incidence of SAGE has been reported to be as high as 4.8% in similar procedures such as CT-guided percutaneous lung biopsy, far exceeding traditional perceptions, the risks associated with bronchoscopy have not received sufficient attention. Currently, reports of SAGE during bronchoscopy are limited to sporadic cases, and there is a lack of systematic prospective studies. As a result, the true incidence, high-risk procedural steps, and definitive risk factors remain unknown, leaving clinical diagnosis and prevention without evidence-based guidance.
To address this research gap, this study is designed as a prospective observational cohort study. It will be conducted at the Laoshan Branch of the Affiliated Hospital of Qingdao University and plans to enroll approximately 500 adult patients undergoing diagnostic or therapeutic bronchoscopy. This study will innovatively combine two non-invasive, highly sensitive monitoring techniques: transthoracic echocardiography (TTE) and transcranial Doppler (TCD). TTE will be used to monitor microbubble signals ("snowstorm-like echoes") in the cardiac chambers in real time and grade their severity, while TCD will be employed to sensitively detect high-frequency transient micro-embolic signals (HITS) in the cerebral arterial circulation, quantifying their number and intensity. Through synchronous intraoperative monitoring, the study aims to accurately capture gas emboli generated during procedures, regardless of whether they cause clinical symptoms.
The primary objective of this study is to determine the actual incidence of SAGE during various bronchoscopic diagnostic and therapeutic procedures. Secondary objectives include comparing the risk of gas emboli associated with different procedures (such as transbronchial lung biopsy, argon plasma coagulation, and laser therapy) and systematically identifying independent risk factors for SAGE through multivariate logistic regression analysis of patient baseline data, comorbidities, and procedural details.
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Notify Me18 year and older
All sexes
Observational
Qingdao, Shangdong, 266000, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
① Poor TTE image quality that prevents assessment of the presence of gas emboli in the cardiac chambers (judged independently by two ultrasound physicians; disagreements resolved through consultation).
② Critically ill patients requiring emergency bronchoscopy procedures (e.g., massive hemoptysis, foreign body aspiration, or severe bronchospasm requiring emergency intubation).
③ Presence of intracardiac shunts (e.g., patent foramen ovale, atrial septal defect, ventricular septal defect).
④ Missing key clinical data.
Time frame: 24 hour
Grade I defined as no emboli visualized in the heart Grade II defined as the presence of one speckle in the RA or RV Grade III defined as gas emboli filling less than half the diameter of the RA or RV Grade IV defined as gas emboli filling more than half the diameter of the RA or RV Grade V defined as gas emboli completely filling the diameter of the RA or RV, and even in the LA or LV (Abbreviations: LA, left atrium; LV, left ventricle; RA, right atrium; RV, right ventricle; TTE, transthoracic echocardiography.)
Time frame: 24 hour
The incidence of gas embolism under different bronchial procedures, such as biopsy, blind examination, TBNA/EBUS, TBLB/radial ultrasound 、APC、 Freezing and electric cutting
Time frame: 24 hour
The sources of gas emboli include the arterial system (left heart), venous system (right heart), and both left and right hearts, and the proportion of gas emboli with different degrees is calculated.
Time frame: 24 hour
Age, gender, primary disease, smoking history, type of operation, operating site, anesthesia method, ventilation method, intraoperative accompanying symptoms
The Affiliated Hospital of Qingdao University
Other
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