- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06078254
Senstivity and Specificity of Lung Ultrasound for Early Detection of ARDS in Patients With Chest Trauma
Accuracy, Senstivity and Specificity of Lung Ultrasound in Comparison to CT Chest for Early Detection of ARDS and Pneumonia in Patients With Chest Trauma
Study Overview
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mohamed R. Elkeey
- Phone Number: 202 01003528221
- Email: MohamedReyad@med.asu.edu.eg
Study Locations
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Cairo, Egypt, 11231
- Recruiting
- AinShams University
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Contact:
- Fatma Ebid, L
- Phone Number: 0000 00201095569596
- Email: mriyad2020@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Evaluation of accuracy ,sensitivity and specificity of lung ultrasound in early detection of acute respiratory distress syndrome and pneumonia in patients with chest trauma.
Time Frame: 18 MONTHS
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Evaluation of accuracy ,sensitivity and specificity of lung ultrasound in early detection of acute respiratory distress syndrome and pneumonia in patients with chest trauma.
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18 MONTHS
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between occurrence of different pulmonary complications due to chest trauma and development of ARDS and pneumonia in patients with chest trauma.
Time Frame: 18 MONTHS
|
Correlation between occurrence of different pulmonary complications due to chest trauma and development of ARDS and pneumonia in patients with chest trauma.
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18 MONTHS
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Omar M. Taha Elsafty, professor, Ain Shams University
- Study Director: Kareem Y. Kamal Hakim, professor, Ain Shams University
- Study Director: Amr G. Sharaf, MD, Ain Shams University
- Study Director: Eman M. Hesham Elshaer, MD, Ain Shams University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ultrasound in chest trauma
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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