Chest TraumaNCT06078254
Senstivity and Specificity of Lung Ultrasound for Early Detection of ARDS in Patients With Chest Trauma
An observational study of Chest Trauma, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Trauma
- What is being tested?
- ULTRASOUND
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2023to 30 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who admitted to critical area with chest trauma will perform both CT chest and lung ultrasound and will be followed up by ultrasound to detect any pulmonary complication and early detection of ARDS and pneumonia.
Who may be able to join
- All ICU patients who got admitted to critical care department with chest trauma.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
AinShams University
Cairo, Cairo Governorate, 11231
Fatma Ebid, L, 00201095569596 ext. 0000, mriyad2020@gmail.com
About this study
Official title: Accuracy, Senstivity and Specificity of Lung Ultrasound in Comparison to CT Chest for Early Detection of ARDS and Pneumonia in Patients With Chest Trauma
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.
Read the 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.
- Conditions
- Chest Trauma
- Being tested
- ULTRASOUND
- Medical subject headings
- Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ULTRASOUNDDevice
Also called COMPUTERIZED TOMOGRAPHY
Ultrasound and CT chest for all patients
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 MONTHS
Secondary outcomes (1)
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.
Measured: 18 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start30 Oct 2023
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chest TraumaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omar M. Taha Elsafty, professor, Study chair, Ain Shams UniversityKareem Y. Kamal Hakim, professor, Study director, Ain Shams UniversityAmr G. Sharaf, MD, Study director, Ain Shams UniversityEman M. Hesham Elshaer, MD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078254
- Sponsor's protocol ID
- Ultrasound in chest trauma
- Status last verified
- May 2025
- First submitted
- 5 Oct 2023
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32417043Ferrer 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.
PubMed 26703094Francone 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.
PubMed 32623505Mardani 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.
PubMed 33976939Pan 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.
PubMed 32053470Soni 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.
PubMed 26218493Raghavendran 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.
PubMed 19174738Hyllienmark 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.
PubMed 23550742
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy, Senstivity and Specificity of Lung Ultrasound in Comparison to CT Chest for Early Detection of ARDS and Pneumonia in Patients With Chest Trauma
- ClinicalTrials.gov ID
- NCT06078254
- Acronym / sponsor ID
- Ultrasound in chest trauma
- Conditions
- Chest Trauma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 11 Oct 2023 (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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who admitted to critical area with chest trauma will perform both CT chest and lung ultrasound and will be followed up by ultrasound to detect any pulmonary complication and early detection of ARDS and pneumonia.
Key inclusion criteria (1 listed)
- All ICU patients who got admitted to critical care department with chest trauma.
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| ULTRASOUNDAlso: COMPUTERIZED TOMOGRAPHYUltrasound and CT chest for all patients | Device | – |
Primary outcome
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
Evaluation of accuracy ,sensitivity and specificity of lung ultrasound in early detection of acute respiratory distress syndrome and pneumonia in patients with chest trauma.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Background: PubMed 32417043Dogrul 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.
- Background: PubMed 26703094Ferrer 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.
- Background: PubMed 32623505Francone 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.
- Background: PubMed 33976939Mardani 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.
- Background: PubMed 32053470Pan 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.
- Background: PubMed 26218493Soni 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.
- Background: PubMed 19174738Raghavendran 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.
- Background: PubMed 23550742Hyllienmark 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.
- Individual participant dataSharing planned: No
Related trials for Chest Trauma
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruitingPhase 1
Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)
Small Cell Lung Carcinoma
Not yet recruitingObservational study
Medical,Nursing Record,PE, Blood Test and Radiological Examination ,Morality and Mobility of Multiple Trauma Patient
Trauma Centers/Statistics & Numerical Data, Trauma Blunt
Not yet recruitingPhase 3
Risk-Adapted Segmental Esophagus-Sparing Radiotherapy for Definitive Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Not yet recruitingObservational study
From Blast Injury to Multicompartment Dysfunction:
Compartment Syndrome, Compartment Syndrome Nontraumatic Lower Extremity
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.
Omar M. Taha Elsafty, professor study chair
Ain Shams University
Kareem Y. Kamal Hakim, professor study director
Ain Shams University
Amr G. Sharaf, MD study director
Ain Shams 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 Chest Trauma, run by Ain Shams 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: looking for participants now, as of the sponsor's last update on 28 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed R. Elkeey (01003528221 ext. 202, MohamedReyad@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 NCT06078254, which also lists 8 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 28 May 2025.