NCT07098546

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 4, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

August 3, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

July 4, 2025

Last Update Submit

August 1, 2025

Conditions

Keywords

pulmonary embolismbubble timepocus

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

1.000.000

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdoğan Üniversitesi Rize Eğitim ve Araştırma Hastanesi

Rize, Merkez, 53020, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 38597847BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency Specialist, Principal Investigator

Study Record Dates

First Submitted

July 4, 2025

First Posted

August 1, 2025

Study Start

July 3, 2025

Primary Completion

October 15, 2025

Study Completion

November 30, 2025

Last Updated

August 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations