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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06078254
Other study ID # Ultrasound in chest trauma
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2023
Est. completion date June 2025

Study information

Verified date September 2023
Source Ain Shams University
Contact Mohamed R. Elkeey
Phone 01003528221
Email MohamedReyad@med.asu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date June 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
ULTRASOUND
Ultrasound and CT chest for all patients

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of accuracy ,sensitivity and specificity of lung ultrasound in early detection of acute respiratory distress syndrome and pneumonia in patients with chest trauma. Evaluation of accuracy ,sensitivity and specificity of lung ultrasound in early detection of acute respiratory distress syndrome and pneumonia in patients with chest trauma. 18 MONTHS
Secondary Correlation between occurrence of different pulmonary complications due to chest trauma and development of ARDS and pneumonia in patients with chest trauma. Correlation between occurrence of different pulmonary complications due to chest trauma and development of ARDS and pneumonia in patients with chest trauma. 18 MONTHS
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