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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in China

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.

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 groups in NCT07555990
Study groupRoleWhat they receive
TTE GroupAll 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted29 Apr 2026
  2. Study start1 Jan 2024
  3. Primary completion30 Nov 2025
  4. Study completion1 Dec 2025

Resources

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
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

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.

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