Pneumothorax At Trauma PatientsNCT06699277
Chest Ultrasound Versus Chest X-ray with Ct As Gold Standard At Trauma Patients
An observational study of Pneumothorax At Trauma Patients, run by Assiut University.
Trial summary
The goal of this observational study is to learn about the predictive value of the chest ultrasound in detection of pneumothorax at chest trauma patients. The main question it aims to answer is: How does the performance of the chest ultrasound compare to chest X-ray in predicting pneumothorax in chest trauma patients… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pneumothorax At Trauma Patients
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Mar 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Blunt chest trauma patients admitted to emergency departments in Assuit and Suez Canal University Hospitals.
Who may be able to join
- patients with different ages.
- both genders.
- Patients presenting with isolated blunt chest trauma.
- Patients who are hemodynamically stable and can undergo imaging studies (Ultrasonography, CXR, and CT).
- Patients who provide informed consent (or proxy consent if the patient incapacitated).
Who cannot join
- Hemodynamically unstable patients requiring immediate surgical intervention.
- Patients with contraindications to CT imaging (e.g., severe renal impairment without access to alternative contrast agents).
- Pregnant patients (due to radiation exposure from CT).
- Patients with previous thoracic surgery or pre-existing significant thoracic abnormalities that could interfere with imaging interpretation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Diagnostic Accuracy of Chest Ultrasonography Vs. Chest X-ray in the Evaluation of Chest Trauma: a Comparative Study Using CT As the Gold Standard.
The goal of this observational study is to learn about the predictive value of the chest ultrasound in detection of pneumothorax at chest trauma patients.
The main question it aims to answer is:
How does the performance of the chest ultrasound compare to chest X-ray in predicting pneumothorax in chest trauma patients in Egypt? Participants are patients with different ages Isolated blunt chest trauma patients admitted to the emergency department during the study period.
Read the detailed description
Chest trauma is a leading cause of morbidity and mortality, with timely and accurate diagnosis essential for effective treatment. While chest X-ray (CXR) has traditionally been the first-line imaging modality in emergency settings due to its availability and ease of use, it has limitations, particularly in detecting subtle or occult injuries like pneumothorax, haemothorax, rib fractures, and pulmonary contusions, especially in trauma patients positioned supine. Overuse of CXR can also lead to increased costs, radiation exposure, and emergency department overcrowding.
Ultrasound has emerged as an alternative, with multiple studies showing that chest ultrasonography (CUS) is highly sensitive and specific for detecting traumatic intrathoracic injuries, including pneumothorax. This systematic review and meta-analysis aimed to assess the diagnostic accuracy of CUS compared to CXR. While CT scans remain the gold standard for diagnosing thoracic trauma due to their superior accuracy, they expose patients to significant radiation and should be used judiciously. Although CXR is a fast and accessible option in emergencies, it may miss critical injuries, highlighting the importance of balancing diagnostic accuracy with patient safety and resource management in trauma care.
The primary aim of this study is to evaluate and compare the diagnostic accuracy of chest ultrasonography (sonar) versus chest X-ray (CXR) in the detection of thoracic injuries in patients presenting with chest trauma, using computed tomography (CT) as the reference standard.
- Conditions
- Pneumothorax At Trauma Patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of chest ultrasonography compared to chest X-ray in the Evaluation of Chest Trauma patients.
To evaluate and compare the diagnostic accuracy of chest ultrasonography (sonar) versus chest X-ray (CXR) in the detection of thoracic injuries in patients presenting with chest trauma, using computed tomography (CT) as the reference standard.
Measured: Hour 3 after patient arrival to ER.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumothorax At Trauma PatientsStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar elmokhtar Abdelaziz khalaf Mohamed Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699277
- Sponsor's protocol ID
- Chest ultrasound vs X-ray
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Chest Ultrasonography Vs. Chest X-ray in the Evaluation of Chest Trauma: a Comparative Study Using CT As the Gold Standard.
- ClinicalTrials.gov ID
- NCT06699277
- Acronym / sponsor ID
- Chest ultrasound vs X-ray
- Conditions
- Pneumothorax At Trauma Patients
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 21 Nov 2024 (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 goal of this observational study is to learn about the predictive value of the chest ultrasound in detection of pneumothorax at chest trauma patients.
The main question it aims to answer is:
How does the performance of the chest ultrasound compare to chest X-ray in predicting pneumothorax in chest trauma patients in Egypt? Participants are patients with different ages Isolated blunt chest trauma patients admitted to the emergency department during the study period.
Detailed description
Chest trauma is a leading cause of morbidity and mortality, with timely and accurate diagnosis essential for effective treatment. While chest X-ray (CXR) has traditionally been the first-line imaging modality in emergency settings due to its availability and ease of use, it has limitations, particularly in detecting subtle or occult injuries like pneumothorax, haemothorax, rib fractures, and pulmonary contusions, especially in trauma patients positioned supine. Overuse of CXR can also lead to increased costs, radiation exposure, and emergency department overcrowding.
Ultrasound has emerged as an alternative, with multiple studies showing that chest ultrasonography (CUS) is highly sensitive and specific for detecting traumatic intrathoracic injuries, including pneumothorax. This systematic review and meta-analysis aimed to assess the diagnostic accuracy of CUS compared to CXR. While CT scans remain the gold standard for diagnosing thoracic trauma due to their superior accuracy, they expose patients to significant radiation and should be used judiciously. Although CXR is a fast and accessible option in emergencies, it may miss critical injuries, highlighting the importance of balancing diagnostic accuracy with patient safety and resource management in trauma care.
The primary aim of this study is to evaluate and compare the diagnostic accuracy of chest ultrasonography (sonar) versus chest X-ray (CXR) in the detection of thoracic injuries in patients presenting with chest trauma, using computed tomography (CT) as the reference standard.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Blunt chest trauma patients admitted to emergency departments in Assuit and Suez Canal University Hospitals.
Key inclusion criteria (5 listed)
- patients with different ages.
- both genders.
- Patients presenting with isolated blunt chest trauma.
- Patients who are hemodynamically stable and can undergo imaging studies (Ultrasonography, CXR, and CT).
- Patients who provide informed consent (or proxy consent if the patient incapacitated).
Key exclusion criteria (4 listed)
- Hemodynamically unstable patients requiring immediate surgical intervention.
- Patients with contraindications to CT imaging (e.g., severe renal impairment without access to alternative contrast agents).
- Pregnant patients (due to radiation exposure from CT).
- Patients with previous thoracic surgery or pre-existing significant thoracic abnormalities that could interfere with imaging interpretation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy of chest ultrasonography compared to chest X-ray in the Evaluation of Chest Trauma patients.
Time frame: Hour 3 after patient arrival to ER.
To evaluate and compare the diagnostic accuracy of chest ultrasonography (sonar) versus chest X-ray (CXR) in the detection of thoracic injuries in patients presenting with chest trauma, using computed tomography (CT) as the reference standard.
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 21 Nov 2024.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumothorax At Trauma Patients, run by Assiut University.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Omar Elmokhtar Abdelaziz Ali, MBBCH (+201023236802, Omar.16266404@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of chest ultrasonography compared to chest X-ray in the Evaluation of Chest Trauma patients. (time frame: Hour 3 after patient arrival to ER.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2024.