'Bubble Time' in Pulmonary Embolism | NCT07098546

Studies
'Bubble Time' in Pulmonary Embolism

NCT07098546

Sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Status

Active, not recruiting

Last Update Posted

Aug 3, 2025Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Tanısal değerlilik

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 3, 2025Actual

Primary Completion Date

Oct 15, 2025Estimated

Completion Date

Nov 30, 2025Estimated

First Submitted Date

Jul 4, 2025

First Submission Date that Met QC Criteria

Jul 24, 2025

First Posted Date

Aug 1, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2025

Last Update Posted Date

Aug 3, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mümin Murat Yazıcı, Emergency Specialist, Principal Investigator, Recep Tayyip Erdogan University Training and Research HospitalPrincipal Investigator

Lead Sponsor

Recep Tayyip Erdogan University Training and Research HospitalOTHER

Collaborators

Name	Class
Marmara University Pendik Training and Research Hospital	OTHER
Gazi University	OTHER
Akdeniz University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study will be multi-centre and prospectively planned. All patients who undergo contrast-enhanced computed tomography in the emergency department with a preliminary diagnosis of pulmonary embolism and who do not meet the exclusion criteria will be included in the study. Informed consent will be obtained from all patients prior to the study. Patients included in the study will undergo bedside ultrasound to assess bubble time, right ventricle-left ventricle ratio, presence of a septal defect, and tricuspid insufficiency, and the diagnostic value of these findings will be evaluated. The bedside ultrasound will be part of the emergency department critical care examination, will not incur any costs for the institution, and will be performed and evaluated by an emergency medicine specialist and assistant.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bubble time	The diagnostic value of bubble time	through study completion, an average of six months
bubble time in pulmonary embolism	The diagnostic value of bubble time in pulmonary embolism	through study completion, an average of six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- All patients presenting to the emergency department with any symptoms, undergoing pulmonary CT angiography due to suspected pulmonary embolism or evaluated as having a strong likelihood of embolism when CT cannot be performed will be included in the study.

Exclusion Criteria:

Patients under the age of 18
Patients with a severe history of tricuspid insufficiency
Patients with a severe of pulmonary hypertension
Patients with a severe of right heart failure
Patients without an echocardiographic report approved by cardiology within 48 hours after emergency admission
Patients in whom ultrasonographic measurements cannot be performed
Patients who refuse diagnosis and treatment voluntarily

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

1.000.000

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Recep Tayyip Erdoğan Üniversitesi Rize Eğitim ve Araştırma Hastanesi		Rize	Merkez	53020	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38597847	Result	Cohen A, Li T, Bielawa N, Nello A, Gold A, Gorlin M, Nelson M, Carlin E, Rolston D. Right Ventricular "Bubble Time" to Identify Patients With Right Ventricular Dysfunction. Ann Emerg Med. 2024 Aug;84(2):182-194. doi: 10.1016/j.annemergmed.2024.02.005. Epub 2024 Apr 10.

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D004617	Embolism
D016769	Embolism and Thrombosis