Embolism VeinNCT07555990
Study on the Incidence and Risk Factors of Systemic Arterial Gas Embolism in Bronchoscopy Procedures
An observational study of Embolism Vein and Air Embolism, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Embolism Vein, Air Embolism
- How many people
- 3,258 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing video bronchoscopy at the Bronchoscopy Room of the Laoshan Branch of Qingdao University Affiliated Hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Shangdong, 266000
About this study
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.
Read more
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.
- Conditions
- Embolism Vein, Air Embolism
- Keywords
- Bronchoscopy, Air Embolism
- Medical subject headings
- Embolism, Air
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TTE Group | All patients were monitored by a unified operator for chest echocardiography, and all bronchoscopy procedures were performed by skilled endoscopists and nurses at the same level. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall incidence of gas emboli during bronchoscopy procedures
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.)
Measured: 24 hour
Secondary outcomes (3)
The incidence of gas emboli under different procedures
The incidence of gas embolism under different bronchial procedures, such as biopsy, blind examination, TBNA/EBUS, TBLB/radial ultrasound 、APC、 Freezing and electric cutting
Measured: 24 hour
The distribution and classification of gas emboli sources
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.
Measured: 24 hour
Factors independently associated with the occurrence of gas embolism
Age, gender, primary disease, smoking history, type of operation, operating site, anesthesia method, ventilation method, intraoperative accompanying symptoms
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Jan 2024
- Primary completion30 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embolism VeinStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- 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
- 3,258 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jixiangyu, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555990
- Sponsor's protocol ID
- QYFYEC2025-204
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Incidence and Risk Factors of Systemic Arterial Gas Embolism in Bronchoscopy Procedures
- ClinicalTrials.gov ID
- NCT07555990
- Acronym / sponsor ID
- QYFYEC2025-204
- Conditions
- Embolism Vein, Air Embolism
- Keywords
- Bronchoscopy, Air Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,258 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 29 Apr 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TTE Group | – | –All patients were monitored by a unified operator for chest echocardiography, and all bronchoscopy procedures were performed by skilled endoscopists and nurses at the same level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing video bronchoscopy at the Bronchoscopy Room of the Laoshan Branch of Qingdao University Affiliated Hospital.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.)
3 secondary outcomes
The incidence of gas emboli under different procedures
Time frame: 24 hour
The distribution and classification of gas emboli sources
Time frame: 24 hour
Factors independently associated with the occurrence of gas embolism
Time frame: 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Embolism Vein and Air Embolism, run by The Affiliated Hospital of Qingdao 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 16 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall incidence of gas emboli during bronchoscopy procedures (time frame: 24 hour). 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 16 Sep 2026.