Value of Transthoracic Ultrasonography (TTU) for Etiologi... | NCT05647655

Studies
Value of Transthoracic Ultrasonography (TTU) for Etiological Diagnosis of Acute Dyspnea: Cross Sectional Study

NCT05647655

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Feb 24, 2023Actual

Enrollment

143Estimated

Phase

Not provided

Conditions

Dyspnea

Interventions

Ultrasonography

Countries

Egypt

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

Dec 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2023Actual

Primary Completion Date

Mar 1, 2024Estimated

Completion Date

Apr 1, 2024Estimated

First Submitted Date

Dec 3, 2022

First Submission Date that Met QC Criteria

Dec 3, 2022

First Posted Date

Dec 12, 2022Actual

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

Feb 22, 2023

Last Update Posted Date

Feb 24, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed Alaa Eldin Abd El Moniem, Principal Investigator, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Evaluating the capability and efficiency of transthoracic ultrasound in attempting to identify the etiology of acute dyspnea.

Detailed Description

Acute dyspnea is a frequent challenge for physicians due to having multiple etiologies, leading to difficulty in establishing an accurate diagnosis.

The presence of this symptom is already a predictor of increased mortality and a lot of investigations are required to differentiate between etiologies. Hence, prompt diagnosis is needed to streamline these patients' appropriate management and disposition from the ED.

Transthoracic ultrasound has traditionally been used for the detection of pleural effusion and evaluation of the chest wall, but the indications have been expanded.

The gold standard imaging technique for the majority of pulmonary disorders is high-resolution computed tomography (HRCT), but it has negatives which are:

hazard of ionizing radiation
high cost
being nonportable

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

143Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasonography	Device	Bedside thoracic ultrasound for patients complaining of acute dyspnea.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Differentiate between different etiologies of acute dyspnea	Analysis of ultrasound findings to differentiate between etiologies of acute dyspnea.	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Detect value of transthoracic ultrasound (TTU) in comparison to CT chest.	Comparison between accuracy of TTU and CT	Baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical history of acute dyspnea

Exclusion Criteria:

Subcutaneous emphysema.
Patients with more than 24 h interval between HRCT and TTU.
Patients with poor-quality of TTU image.

Accepts Healthy Volunteers

Not provided

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

Patients older than 18 years with acute dyspnea will be included

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed A Elsayed, MBBCH	Contact	01126091101	02	ahmeda.abdelmoniem@hotmail.com

Overall Officials

Name	Affiliation	Role
Ahmed A Elsayed, MBBCH	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University hospital	Recruiting	Asyut		71515	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20433006	Background	Gargani L, Fontana M, Sicari R, Picano E. [Differential diagnosis of dyspnea: the incremental value of lung ultrasound]. Recenti Prog Med. 2010 Feb;101(2):78-82. Italian.
35698060	Background	Baid H, Vempalli N, Kumar S, Arora P, Walia R, Chauhan U, Shukla K, Verma A, Chawang H, Agarwal D. Point of care ultrasound as initial diagnostic tool in acute dyspnea patients in the emergency department of a tertiary care center: diagnostic accuracy study. Int J Emerg Med. 2022 Jun 13;15(1):27. doi: 10.1186/s12245-022-00430-8.

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis