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Completed

NCT Number: NCT07555990

Study on the Incidence and Risk Factors of Systemic Arterial Gas Embolism in Bronchoscopy Procedures

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Affiliated Hospital of Qingdao University

Qingdao, Shangdong, 266000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing electronic bronchoscopy for diagnostic and/or therapeutic procedures. If the same patient undergoes multiple procedures, each procedure is considered an independent observation unit.
  • Intraoperative real-time transthoracic echocardiography (TTE) monitoring completed.
  • Age ≥ 18 years. ④ Signed informed consent.

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.

Treatment and study plan

Primary outcomes

  1. The overall incidence of gas emboli during bronchoscopy procedures

    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.)

Secondary outcomes

  1. The incidence of gas emboli under different procedures

    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

  2. The distribution and classification of gas emboli sources

    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.

  3. Factors independently associated with the occurrence of gas embolism

    Time frame: 24 hour

    Age, gender, primary disease, smoking history, type of operation, operating site, anesthesia method, ventilation method, intraoperative accompanying symptoms

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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