Contusions PulmonaryNCT05054270
Efficacy of Lung Ultrasound in Monitoring Fluid Resuscitation in Chest Trauma Patients
An observational study of Contusions Pulmonary and Lung Injury, run by Assiut University at 1 site in Egypt.
Trial summary
Efficacy of Lung ultrasound in monitoring fluid resuscitation in chest trauma patients with lung contusions Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contusions Pulmonary, Lung Injury, Chest Trauma
- What is being tested?
- Chest examination with Ultrasound device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: This is an observational study that will be conducted on patients admitted with chest trauma in Assuit or Alexandria Main University Hospitals after obtaining their or their next of kin consent to participate in the study without affecting their course of treatment according to permission obtained from ethical committee of faculty of medicine in Assiut and Alexandria universities.
Who may be able to join
- Age > 18 years.
- chest trauma patients either with or without other injuries.
- Any patient with either blunt or penetrating chest trauma.
Who cannot join
- - Patients in cardiac arrest.
- Patient refusal to participate
- Pregnant females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Lung Ultrasound in Monitoring Fluid Resuscitation in Trauma Patients
Efficacy of Lung ultrasound in monitoring fluid resuscitation in chest trauma patients with lung contusions
Read the detailed description
Trauma is a public health problem, associated to high morbidity and mortality, In Egypt the mortality from road traffic crashes is about 12000 victims per year.
- Chest trauma represents from 10% to 15% of the total number of traumas worldwide.
According to ATLS protocol , early diagnosis and management of Chest trauma are essential. *Pulmonary contusion is found in 30-75% of cases of chest injury.
- point of care Ultrasound (POCUS) is Now a corner stone in Emergency management it can predict lung contusions within the first 72 hours after trauma.
- Recently, LUS Play a major role in assessment of the volume status in Trauma patients.
- B-lines score (BLS) has been validated as a lung ultrasound quantification of pulmonary congestion.The sum of all B-lines yields a score, B-lines score (BLS), which assess the degree of lung contusion. So that LUS may provide a valuable safety threshold to conduct fluid therapy.
- Being tested
- Chest examination with Ultrasound device
- Medical subject headings
- Lung Injury, Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest examination with Ultrasound deviceOther
Chest examination with Ultrasound device
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with lung contusion
Pulmonary edema will be detected by B_lines trauma patients with lung contusions
Measured: Upto 24 hours after trauma
Secondary outcomes (1)
Clinical correlation between Type & volume of Fluid & occurance of pulmonary edema. Correlation between severity of pulmonary lung contusion & The final disposition of the patients whatever (OR _another department _death….. etc) upto 24hr.
Follow up on degree of contusions after fluid resuscitation
Measured: For first 24 hours after trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start1 Jul 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Contusions PulmonaryStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Yassien Mahmoud Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054270
- Sponsor's protocol ID
- Chest US in lung contusion
- Status last verified
- Jul 2021
- First submitted
- 2 Jun 2021
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ullman EA, Donley LP, Brady WJ. Pulmonary trauma emergency department evaluation and management. Emerg Med Clin North Am. 2003 May;21(2):291-313. doi: 10.1016/s0733-8627(03)00016-6.
PubMed 12793615Miller DL, Mansour KA. Blunt traumatic lung injuries. Thorac Surg Clin. 2007 Feb;17(1):57-61, vi. doi: 10.1016/j.thorsurg.2007.03.017.
PubMed 17650697Cohn SM. Pulmonary contusion: review of the clinical entity. J Trauma. 1997 May;42(5):973-9. doi: 10.1097/00005373-199705000-00033.
PubMed 9191684
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lung Ultrasound in Monitoring Fluid Resuscitation in Trauma Patients
- ClinicalTrials.gov ID
- NCT05054270
- Acronym / sponsor ID
- Chest US in lung contusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 23 Sep 2021 (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.
Efficacy of Lung ultrasound in monitoring fluid resuscitation in chest trauma patients with lung contusions
Detailed description
Trauma is a public health problem, associated to high morbidity and mortality, In Egypt the mortality from road traffic crashes is about 12000 victims per year.
- Chest trauma represents from 10% to 15% of the total number of traumas worldwide.
According to ATLS protocol , early diagnosis and management of Chest trauma are essential. *Pulmonary contusion is found in 30-75% of cases of chest injury.
- point of care Ultrasound (POCUS) is Now a corner stone in Emergency management it can predict lung contusions within the first 72 hours after trauma.
- Recently, LUS Play a major role in assessment of the volume status in Trauma patients.
- B-lines score (BLS) has been validated as a lung ultrasound quantification of pulmonary congestion.The sum of all B-lines yields a score, B-lines score (BLS), which assess the degree of lung contusion. So that LUS may provide a valuable safety threshold to conduct fluid therapy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This is an observational study that will be conducted on patients admitted with chest trauma in Assuit or Alexandria Main University Hospitals after obtaining their or their next of kin consent to participate in the study without affecting their course of treatment according to permission obtained from ethical committee of faculty of medicine in Assiut and Alexandria universities.
Key inclusion criteria (3 listed)
- Age > 18 years.
- chest trauma patients either with or without other injuries.
- Any patient with either blunt or penetrating chest trauma.
Key exclusion criteria (3 listed)
- - Patients in cardiac arrest.
- Patient refusal to participate
- Pregnant females.
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 |
|---|---|---|
| Chest examination with Ultrasound deviceChest examination with Ultrasound device | Other | – |
Primary outcome
Number of patients with lung contusion
Time frame: Upto 24 hours after trauma
Pulmonary edema will be detected by B_lines trauma patients with lung contusions
1 secondary outcome
Clinical correlation between Type & volume of Fluid & occurance of pulmonary edema. Correlation between severity of pulmonary lung contusion & The final disposition of the patients whatever (OR _another department _death….. etc) upto 24hr.
Time frame: For first 24 hours after trauma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Background: PubMed 12793615Ullman EA, Donley LP, Brady WJ. Pulmonary trauma emergency department evaluation and management. Emerg Med Clin North Am. 2003 May;21(2):291-313. doi: 10.1016/s0733-8627(03)00016-6.
- Background: PubMed 17650697Miller DL, Mansour KA. Blunt traumatic lung injuries. Thorac Surg Clin. 2007 Feb;17(1):57-61, vi. doi: 10.1016/j.thorsurg.2007.03.017.
- Background: PubMed 9191684Cohn SM. Pulmonary contusion: review of the clinical entity. J Trauma. 1997 May;42(5):973-9. doi: 10.1097/00005373-199705000-00033.
- Individual participant dataSharing planned: Undecided
Related trials for Contusions Pulmonary
Not yet recruitingObservational study
Combined Lung and Diaphragmatic Ultrasound to Predict Respiratory Failure in Blunt Chest Trauma
Blunt Chest Trauma, Respiratory Failure
Not yet recruitingObservational study
Non-Invasive Dynamic Monitoring-Guided Oscillation and Lung Expansion for Airway Clearance in Severe Blunt Chest Trauma: A Clinical Study
Blunt Chest Trauma
Recruiting
Effects of Non-invasive Ventilation Therapies on the Lung in Hypoxemic Chest Trauma Patients
Lung Trauma, Lung Contusion
RecruitingObservational study
AI in the Identification of Lung Contusions Through Chest Radiological Examination in Blunt Thoracic Trauma
Lung Contusion
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Contusions Pulmonary and Lung Injury, run by Assiut 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 3 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: finished, as of the sponsor's last update on 30 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with lung contusion (time frame: Upto 24 hours after trauma). 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 NCT05054270, which also lists 3 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 30 Jul 2024.