Chest Trauma PatientsNCT05960409
Outcome of Chest Trauma Patients in One Year in Sohag University Hospital
An observational study of Chest Trauma Patients, run by Sohag University at 1 site in Egypt.
Trial summary
The history of chest trauma is as old as that of man himself. One of the earliest writings about chest trauma is found in the Edwin Smith Surgical Papyrus, written in 3000 bc. Over the last century, there has been considerable reduction in the mortality of chest trauma owing to improved pre-operative care… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chest Trauma Patients
- What is being tested?
- chest tube - emergency thoracotomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2023to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: * males and females * adults and children * isolated chest trauma * polytraumatized patients * penetrating chest trauma * blunt chest trauma
Who may be able to join
- males and females
- adults and children
- isolated chest trauma
- polytraumatized patients
- penetrating chest trauma
- blunt chest trauma
Who cannot join
- patients presented with cardiac arrest
- patients presented dead
- patients with glasco coma scale 5 or less
- patients with sever abdominal injuries
Trial locations and contacts
1 site in 1 country.
Essam A Mokhtar, professor contact
About this study
The history of chest trauma is as old as that of man himself. One of the earliest writings about chest trauma is found in the Edwin Smith Surgical Papyrus, written in 3000 bc.
Over the last century, there has been considerable reduction in the mortality of chest trauma owing to improved pre-operative care, availability of positive pressure ventilation, increasing availability of antibiotics, improvement of radiological techniques and improved lung toilets measures etc.
Read more
Chest trauma implies trauma to any or combination of different thoracic structures, which can be divided into 4 anatomical regions i.e. the chest wall, the pleural space, the lung parenchyma, and the mediastinum.
Trauma is one of the top ranking causes of accidental or unnatural deaths. Chest trauma is a significant source of morbidity and mortality worldwide. overall, it accounts for 25%-30% of all trauma related deaths and is implicated in an additional 25% of patients, who died from injuries.
In most cases, blunt chest trauma is by far the commonest and road traffic accidents account for 70%-80% of such injuries. Fire-arm injuries, falling from height, blast, stabs, and various acts of violence are the other causative mechanisms.
- Conditions
- Chest Trauma Patients
- Being tested
- chest tube - emergency thoracotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest tube - emergency thoracotomyProcedure or surgery
chest tube is an inter-costal tube inserted intrathoracic in case of haemothorax and pneumothorax ,,,, emergency thoracotomy is an emergency exploration in severly injured patients
| Study group | Role | What they receive |
|---|---|---|
| blunt chest trauma patients | patients with chest injuries due to a blunt trauma Receives: Procedure: chest tube - emergency thoracotomy | |
| penetrating chest trauma patients | patients with chest injuries due to penetrating trauma Receives: Procedure: chest tube - emergency thoracotomy | |
| polytraumatized patients | patients with multible traumas beside the chest injury Receives: Procedure: chest tube - emergency thoracotomy | |
| chest trauma only patients | patients with only chest injuries Receives: Procedure: chest tube - emergency thoracotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
morbidity
Outcome will be defined as conservative management
Measured: 12 months
mortality
Outcome will be defined as conservative management
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study startAug 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chest Trauma PatientsStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mohamed Abdelhameed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960409
- Sponsor's protocol ID
- Soh-Med-23-07-06MS
- Status last verified
- Jul 2023
- First submitted
- 17 Jul 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mommsen P, Zeckey C, Andruszkow H, Weidemann J, Fromke C, Puljic P, van Griensven M, Frink M, Krettek C, Hildebrand F. Comparison of different thoracic trauma scoring systems in regards to prediction of post-traumatic complications and outcome in blunt chest trauma. J Surg Res. 2012 Jul;176(1):239-47. doi: 10.1016/j.jss.2011.09.018. Epub 2011 Oct 5.
PubMed 22099585Grubmuller M, Kerschbaum M, Diepold E, Angerpointner K, Nerlich M, Ernstberger A. Severe thoracic trauma - still an independent predictor for death in multiple injured patients? Scand J Trauma Resusc Emerg Med. 2018 Jan 8;26(1):6. doi: 10.1186/s13049-017-0469-7.
PubMed 29310701Ekpe EE, Eyo C. Determinants of mortality in chest trauma patients. Niger J Surg. 2014 Jan;20(1):30-4. doi: 10.4103/1117-6806.127107.
PubMed 24665200Al-Koudmani I, Darwish B, Al-Kateb K, Taifour Y. Chest trauma experience over eleven-year period at al-mouassat university teaching hospital-Damascus: a retrospective review of 888 cases. J Cardiothorac Surg. 2012 Apr 19;7:35. doi: 10.1186/1749-8090-7-35.
PubMed 22515842
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Chest Trauma Patients in One Year in Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05960409
- Acronym / sponsor ID
- Soh-Med-23-07-06MS
- Conditions
- Chest Trauma Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 25 Jul 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 history of chest trauma is as old as that of man himself. One of the earliest writings about chest trauma is found in the Edwin Smith Surgical Papyrus, written in 3000 bc.
Over the last century, there has been considerable reduction in the mortality of chest trauma owing to improved pre-operative care, availability of positive pressure ventilation, increasing availability of antibiotics, improvement of radiological techniques and improved lung toilets measures etc.
Chest trauma implies trauma to any or combination of different thoracic structures, which can be divided into 4 anatomical regions i.e. the chest wall, the pleural space, the lung parenchyma, and the mediastinum.
Trauma is one of the top ranking causes of accidental or unnatural deaths. Chest trauma is a significant source of morbidity and mortality worldwide. overall, it accounts for 25%-30% of all trauma related deaths and is implicated in an additional 25% of patients, who died from injuries.
In most cases, blunt chest trauma is by far the commonest and road traffic accidents account for 70%-80% of such injuries. Fire-arm injuries, falling from height, blast, stabs, and various acts of violence are the other causative mechanisms.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| blunt chest trauma patients | – | Procedure: chest tube - emergency thoracotomypatients with chest injuries due to a blunt trauma |
| penetrating chest trauma patients | – | Procedure: chest tube - emergency thoracotomypatients with chest injuries due to penetrating trauma |
| polytraumatized patients | – | Procedure: chest tube - emergency thoracotomypatients with multible traumas beside the chest injury |
| chest trauma only patients | – | Procedure: chest tube - emergency thoracotomypatients with only chest injuries |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * males and females * adults and children * isolated chest trauma * polytraumatized patients * penetrating chest trauma * blunt chest trauma
Key inclusion criteria (6 listed)
- males and females
- adults and children
- isolated chest trauma
- polytraumatized patients
- penetrating chest trauma
Key exclusion criteria (4 listed)
- patients presented with cardiac arrest
- patients presented dead
- patients with glasco coma scale 5 or less
- patients with sever abdominal injuries
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 tube - emergency thoracotomychest tube is an inter-costal tube inserted intrathoracic in case of haemothorax and pneumothorax ,,,, emergency thoracotomy is an emergency exploration in severly injured patients | Procedure or surgery | blunt chest trauma patients, chest trauma only patients, penetrating chest trauma patients, polytraumatized patients |
Primary outcome
morbidity
Time frame: 12 months
Outcome will be defined as conservative management
mortality
Time frame: 12 months
Outcome will be defined as conservative management
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Background: PubMed 22099585Mommsen P, Zeckey C, Andruszkow H, Weidemann J, Fromke C, Puljic P, van Griensven M, Frink M, Krettek C, Hildebrand F. Comparison of different thoracic trauma scoring systems in regards to prediction of post-traumatic complications and outcome in blunt chest trauma. J Surg Res. 2012 Jul;176(1):239-47. doi: 10.1016/j.jss.2011.09.018. Epub 2011 Oct 5.
- Background: PubMed 29310701Grubmuller M, Kerschbaum M, Diepold E, Angerpointner K, Nerlich M, Ernstberger A. Severe thoracic trauma - still an independent predictor for death in multiple injured patients? Scand J Trauma Resusc Emerg Med. 2018 Jan 8;26(1):6. doi: 10.1186/s13049-017-0469-7.
- Background: PubMed 24665200Ekpe EE, Eyo C. Determinants of mortality in chest trauma patients. Niger J Surg. 2014 Jan;20(1):30-4. doi: 10.4103/1117-6806.127107.
- Background: PubMed 22515842Al-Koudmani I, Darwish B, Al-Kateb K, Taifour Y. Chest trauma experience over eleven-year period at al-mouassat university teaching hospital-Damascus: a retrospective review of 888 cases. J Cardiothorac Surg. 2012 Apr 19;7:35. doi: 10.1186/1749-8090-7-35.
- Individual participant dataSharing planned: Undecided
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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.
Essam A Mokhtar, professor contact
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 Patients, run by Sohag 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 6 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: status not confirmed, as of the sponsor's last update on 25 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr M Mohammed, resident (01008948139, amrelsayed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morbidity (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT05960409, which also lists 4 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 25 Jul 2023.