DyspneaNCT05647655
Value of Transthoracic Ultrasonography (TTU) for Etiological Diagnosis of Acute Dyspnea: Cross Sectional Study
An observational study of Dyspnea, run by Assiut University at 1 site in Egypt.
Trial summary
Evaluating the capability and efficiency of transthoracic ultrasound in attempting to identify the etiology of acute dyspnea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- Ultrasonography
- Type of treatment
- Medical device
- How many people
- 143 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2023to 1 Apr 2024
- 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
- Adult, Older adult
Study population: Patients older than 18 years with acute dyspnea will be included
Who may be able to join
- Clinical history of acute dyspnea
Who cannot join
- Subcutaneous emphysema.
- Patients with more than 24 h interval between HRCT and TTU.
- Patients with poor-quality of TTU image.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University hospital
Asyut, 71515
Mohamed A Hefny, MD, 01009319309, dr.m.tawab@gmail.com
About this study
Evaluating the capability and efficiency of transthoracic ultrasound in attempting to identify the etiology of acute dyspnea.
Read the 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
- Conditions
- Dyspnea
- Being tested
- Ultrasonography
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDevice
Bedside thoracic ultrasound for patients complaining of acute dyspnea.
What is being measured
The primary outcome is the main question the study is designed to answer.
Differentiate between different etiologies of acute dyspnea
Analysis of ultrasound findings to differentiate between etiologies of acute dyspnea.
Measured: Baseline
Secondary outcomes (1)
Detect value of transthoracic ultrasound (TTU) in comparison to CT chest.
Comparison between accuracy of TTU and CT
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start20 Feb 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Alaa Eldin Abd El Moniem, Assiut University
- Investigators
- Ahmed A Elsayed, MBBCH, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647655
- Sponsor's protocol ID
- US in Acute dyspnea
- Status last verified
- Dec 2022
- First submitted
- 3 Dec 2022
- Last updated
- 24 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20433006Baid 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.
PubMed 35698060Vitturi N, Soattin M, Allemand E, Simoni F, Realdi G. Thoracic ultrasonography: A new method for the work-up of patients with dyspnea(). J Ultrasound. 2011 Sep;14(3):147-51. doi: 10.1016/j.jus.2011.06.009. Epub 2011 Jun 30.
PubMed 23396858Li H, Li YD, Zhu WW, Sun LL, Ye XG, Kong LY, Cai QZ, Jiang W, Wang L, Lu XZ. High-Resolution Transthoracic Ultrasonography for Assessment of Pleural Lines in Patients With Dyspnea With CT Comparison: An Observational Study. J Ultrasound Med. 2017 Apr;36(4):707-716. doi: 10.7863/ultra.16.04030. Epub 2017 Jan 27.
PubMed 28127786Lancellotti P, Price S, Edvardsen T, Cosyns B, Neskovic AN, Dulgheru R, Flachskampf FA, Hassager C, Pasquet A, Gargani L, Galderisi M, Cardim N, Haugaa KH, Ancion A, Zamorano JL, Donal E, Bueno H, Habib G. The use of echocardiography in acute cardiovascular care: recommendations of the European Association of Cardiovascular Imaging and the Acute Cardiovascular Care Association. Eur Heart J Cardiovasc Imaging. 2015 Feb;16(2):119-46. doi: 10.1093/ehjci/jeu210. Epub 2014 Nov 6.
PubMed 25378470
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Transthoracic Ultrasonography (TTU) for Etiological Diagnosis of Acute Dyspnea: Cross Sectional Study
- ClinicalTrials.gov ID
- NCT05647655
- Acronym / sponsor ID
- US in Acute dyspnea
- Conditions
- Dyspnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 12 Dec 2022 (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.
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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years with acute dyspnea will be included
Key inclusion criteria (1 listed)
- Clinical history of acute dyspnea
Key exclusion criteria (3 listed)
- Subcutaneous emphysema.
- Patients with more than 24 h interval between HRCT and TTU.
- Patients with poor-quality of TTU image.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasonographyBedside thoracic ultrasound for patients complaining of acute dyspnea. | Device | – |
Primary outcome
Differentiate between different etiologies of acute dyspnea
Time frame: Baseline
Analysis of ultrasound findings to differentiate between etiologies of acute dyspnea.
1 secondary outcome
Detect value of transthoracic ultrasound (TTU) in comparison to CT chest.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Background: PubMed 20433006Gargani 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.
- Background: PubMed 35698060Baid 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.
- Background: PubMed 23396858Vitturi N, Soattin M, Allemand E, Simoni F, Realdi G. Thoracic ultrasonography: A new method for the work-up of patients with dyspnea(). J Ultrasound. 2011 Sep;14(3):147-51. doi: 10.1016/j.jus.2011.06.009. Epub 2011 Jun 30.
- Background: PubMed 28127786Li H, Li YD, Zhu WW, Sun LL, Ye XG, Kong LY, Cai QZ, Jiang W, Wang L, Lu XZ. High-Resolution Transthoracic Ultrasonography for Assessment of Pleural Lines in Patients With Dyspnea With CT Comparison: An Observational Study. J Ultrasound Med. 2017 Apr;36(4):707-716. doi: 10.7863/ultra.16.04030. Epub 2017 Jan 27.
- Background: PubMed 25378470Lancellotti P, Price S, Edvardsen T, Cosyns B, Neskovic AN, Dulgheru R, Flachskampf FA, Hassager C, Pasquet A, Gargani L, Galderisi M, Cardim N, Haugaa KH, Ancion A, Zamorano JL, Donal E, Bueno H, Habib G. The use of echocardiography in acute cardiovascular care: recommendations of the European Association of Cardiovascular Imaging and the Acute Cardiovascular Care Association. Eur Heart J Cardiovasc Imaging. 2015 Feb;16(2):119-46. doi: 10.1093/ehjci/jeu210. Epub 2014 Nov 6.
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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.
Ahmed A Elsayed, MBBCH principal investigator
Assiut University
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 Dyspnea, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Feb 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Elsayed, MBBCH (01126091101 ext. 02, ahmeda.abdelmoniem@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differentiate between different etiologies of acute dyspnea (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05647655, which also lists 5 linked publications.
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 24 Feb 2023.