Senstivity and Specificity of Lung Ultrasound for Early Detection of ARDS in Patients With Chest Trauma

NCT ID: NCT06078254

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-30

Study Completion Date

2025-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to evaluate the accuracy, sensitivity and specificity of lung ultrasound in early detection of ARDS and Pneumonia in comparison to CT chest in patients with chest trauma. Also, we aim at finding any pulmonary complications and its correlation to development of ARDS and pneumonia in patients with chest trauma.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Thoracic trauma has significant morbidity and mortality. It is the fourth most common trauma site after the head, abdomen, pelvis and extremities.

Thoracic trauma is one of the critical injury mechanisms in multiply injured trauma victims. Although these patients present a plethora of potential structural damages to vital organs, it remains debated which injuries actually influence outcome and thereby should be addressed initially.

Routine tests for chest injuries include chest X-rays and computed tomography (CT) scans. Chest X-rays are available but are insufficiently sensitive for chest trauma. Multi-detector CT is now considered the gold standard imaging tool in the emergency department; however, it is not applicable for unstable patients and is unavailable in intensive care units, so patient transport to radiology departments is required. This technique also exposes patients to high doses of ionizing radiation.

In thoracic trauma cases, ultrasonography of the lungs is valuable for evaluating various chest diseases, including chest wall hematoma and fractures, pleural cavity involvement with pleural effusion, hemothorax, and pneumothorax, and pericardial cavity involvement with hemopericardium.

The ultrasound can also assess the reduce in lung aeration in acute diseases by changing the lung surface and generating distinct patterns as in pulmonary contusions and compression atelectasis.

In pneumothorax cases, the major criterion for ultrasound diagnosis is the absence of lung sliding during a dynamic examination, as well as the absence of a pleural gap and lung point, which is the transitional area between the breath-dependent, moving lung and the pleural air column in cases of partial pneumothorax with incomplete lung collapse.

Lung contusion is the most frequent thoracic injury in blunt chest trauma and it is associated with increased morbidity and mortality. Direct damage of the lung tissue causes both local and systemic inflammatory responses that can lead to acute respiratory distress syndrome (ARDS) and multiple organ failure. The initial size of the lung contusion seems to play a key role in these mechanisms.Several CT scan studies have shown that initial lung contusion volume is predictive of the development of subsequent ARDS.

Ultrasounds aids in pleural effusion detection, even if minimal. Ultrasound can assess and quantify the amount of effusion, and characterize its internal complexity, such as septations, exudative effusion, fibrin strands, and echogenic pleural effusion.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chest Trauma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ULTRASOUND

Ultrasound and CT chest for all patients

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

COMPUTERIZED TOMOGRAPHY

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All ICU patients who got admitted to critical care department with chest trauma.

Exclusion Criteria

* Pediatric patients aged less than 18 years old.
* Any patients have previous lung disease like (IPF, lung cancer, respiratory failure and pulmonary hypertension).
* Pregnant females at any gestational age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Omar M. Taha Elsafty, professor

Role: STUDY_CHAIR

Ain Shams University

Kareem Y. Kamal Hakim, professor

Role: STUDY_DIRECTOR

Ain Shams University

Amr G. Sharaf, MD

Role: STUDY_DIRECTOR

Ain Shams University

Eman M. Hesham Elshaer, MD

Role: STUDY_DIRECTOR

Ain Shams University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AinShams University

Cairo, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohamed R. Elkeey

Role: CONTACT

01003528221 ext. 202

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Fatma Ebid, L

Role: primary

00201095569596 ext. 0000

References

Explore related publications, articles, or registry entries linked to this study.

Dogrul BN, Kiliccalan I, Asci ES, Peker SC. Blunt trauma related chest wall and pulmonary injuries: An overview. Chin J Traumatol. 2020 Jun;23(3):125-138. doi: 10.1016/j.cjtee.2020.04.003. Epub 2020 Apr 20.

Reference Type BACKGROUND
PMID: 32417043 (View on PubMed)

Ferrer M, Difrancesco LF, Liapikou A, Rinaudo M, Carbonara M, Li Bassi G, Gabarrus A, Torres A. Polymicrobial intensive care unit-acquired pneumonia: prevalence, microbiology and outcome. Crit Care. 2015 Dec 23;19:450. doi: 10.1186/s13054-015-1165-5.

Reference Type BACKGROUND
PMID: 26703094 (View on PubMed)

Francone M, Iafrate F, Masci GM, Coco S, Cilia F, Manganaro L, Panebianco V, Andreoli C, Colaiacomo MC, Zingaropoli MA, Ciardi MR, Mastroianni CM, Pugliese F, Alessandri F, Turriziani O, Ricci P, Catalano C. Chest CT score in COVID-19 patients: correlation with disease severity and short-term prognosis. Eur Radiol. 2020 Dec;30(12):6808-6817. doi: 10.1007/s00330-020-07033-y. Epub 2020 Jul 4.

Reference Type BACKGROUND
PMID: 32623505 (View on PubMed)

Mardani P, Moayedi Rad M, Paydar S, Amirian A, Shahriarirad R, Erfani A, Ranjbar K. Evaluation of Lung Contusion, Associated Injuries, and Outcome in a Major Trauma Center in Shiraz, Southern Iran. Emerg Med Int. 2021 Apr 22;2021:3789132. doi: 10.1155/2021/3789132. eCollection 2021.

Reference Type BACKGROUND
PMID: 33976939 (View on PubMed)

Pan F, Ye T, Sun P, Gui S, Liang B, Li L, Zheng D, Wang J, Hesketh RL, Yang L, Zheng C. Time Course of Lung Changes at Chest CT during Recovery from Coronavirus Disease 2019 (COVID-19). Radiology. 2020 Jun;295(3):715-721. doi: 10.1148/radiol.2020200370. Epub 2020 Feb 13.

Reference Type BACKGROUND
PMID: 32053470 (View on PubMed)

Soni NJ, Franco R, Velez MI, Schnobrich D, Dancel R, Restrepo MI, Mayo PH. Ultrasound in the diagnosis and management of pleural effusions. J Hosp Med. 2015 Dec;10(12):811-6. doi: 10.1002/jhm.2434. Epub 2015 Jul 28.

Reference Type BACKGROUND
PMID: 26218493 (View on PubMed)

Raghavendran K, Notter RH, Davidson BA, Helinski JD, Kunkel SL, Knight PR. Lung contusion: inflammatory mechanisms and interaction with other injuries. Shock. 2009 Aug;32(2):122-30. doi: 10.1097/SHK.0b013e31819c385c.

Reference Type BACKGROUND
PMID: 19174738 (View on PubMed)

Hyllienmark P, Brattstrom O, Larsson E, Martling CR, Petersson J, Oldner A. High incidence of post-injury pneumonia in intensive care-treated trauma patients. Acta Anaesthesiol Scand. 2013 Aug;57(7):848-54. doi: 10.1111/aas.12111. Epub 2013 Mar 31.

Reference Type BACKGROUND
PMID: 23550742 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Ultrasound in chest trauma

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.