Flail ChestNCT06755723
Mortality Causes in Rib Surgery Patients
An observational study of Flail Chest and Rib Fractures, run by Caner İşevi, MD.
Trial summary
This study retrospectively investigates the causes of mortality and morbidity in patients undergoing rib fracture surgery due to blunt trauma. The primary objective is to determine whether pulmonary contusion or associated extrathoracic trauma plays a more significant role in adverse outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Flail Chest, Rib Fractures, Thoracic Injuries
- What is being tested?
- Rib fractures manangement
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Jan 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with blunt trauma-induced rib fractures leading to flail chest, treated with rib stabilization surgery in a hospital setting.
Who may be able to join
- Patients aged 18-80 years diagnosed with flail chest following blunt trauma who underwent rib stabilization surgery
- Those with complete clinical and laboratory data
- Those with at least 30 days of follow-up after surgery.
Who cannot join
- Patients under 18 years of age
- Flail chest patients who did not require rib stabilization surgery
- Patients with incomplete clinical or laboratory data
- Those with penetrating thoracic trauma.
About this study
Official title: The Underlying Cause of Mortality and Morbidity in Patients Undergoing Rib Fracture Surgery: Pulmonary Contusion or Associated Extrathoracic Trauma?
This study retrospectively investigates the causes of mortality and morbidity in patients undergoing rib fracture surgery due to blunt trauma. The primary objective is to determine whether pulmonary contusion or associated extrathoracic trauma plays a more significant role in adverse outcomes. Data collected includes patient demographics, trauma mechanisms, associated injuries, surgical timing, and clinical outcomes. The study aims to provide insights into improving management strategies for trauma patients and reducing complication rates through early identification and tailored interventions.
Read the detailed description
This retrospective study investigates the underlying causes of morbidity and mortality in patients who underwent rib stabilization surgery due to blunt trauma-induced rib fractures. The primary objective is to determine whether pulmonary contusion or associated extrathoracic trauma plays a more significant role in adverse outcomes such as pneumonia, prolonged air leaks, tracheostomy, wound infections, and mortality.
The study includes patients diagnosed with flail chest who underwent rib stabilization surgery between January 1, 2014, and January 1, 2024, at a single tertiary care center. Collected data encompasses patient demographics, trauma mechanisms, associated injuries (thoracic and extrathoracic), surgery timing (early vs. late stabilization), ventilator settings, extubation duration, intensive care unit (ICU) and hospital length of stay, laboratory parameters, and clinical outcomes.
Key outcomes include the incidence of morbidity (e.g., pneumonia, prolonged air leak, wound infections) and mortality. Statistical analyses will evaluate the relationship between these outcomes and factors such as the severity and timing of injuries, surgery timing, trauma mechanisms, and associated injuries.
The study aims to provide valuable insights into optimizing the management of flail chest patients, emphasizing the importance of early rib stabilization and a multidisciplinary approach. These findings are expected to contribute to the development of standardized protocols for patient selection and intervention timing, potentially improving patient outcomes in multitrauma settings.
- Conditions
- Flail Chest, Rib Fractures, Thoracic Injuries, Pulmonary Contusion, Blunt Trauma
- Being tested
- Rib fractures manangement
- Keywords
- Flail chest, Rib fractures, Pulmonary contusion, Multiple trauma
- Medical subject headings
- Flail Chest, Rib Fractures, Thoracic Injuries, Wounds, Nonpenetrating, Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rib fractures manangementOther
This is an observational study, so participants are not assigned interventions. However, the study investigates the outcomes of patients undergoing rib stabilization surgery as part of their routine clinical care. The exposure of interest includes surgical rib stabilization and its timing, combined with any related clinical and care procedures. The outcomes and clinical data collected reflect routine care practices.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Rate in Patients Undergoing Rib Stabilization Surgery
The primary outcome measure is the overall mortality rate among patients with flail chest due to blunt trauma, treated with rib stabilization surgery. The analysis will focus on the association between mortality and factors such as trauma severity and associated injuries.
Measured: Within 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Jan 2014
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flail ChestStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caner İşevi, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Caner İşevi, MD, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755723
- Sponsor's protocol ID
- B.30.2.ODM.0.20.08/713
- Status last verified
- Dec 2024
- First submitted
- 24 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Underlying Cause of Mortality and Morbidity in Patients Undergoing Rib Fracture Surgery: Pulmonary Contusion or Associated Extrathoracic Trauma?
- ClinicalTrials.gov ID
- NCT06755723
- Acronym / sponsor ID
- B.30.2.ODM.0.20.08/713
- Conditions
- Flail Chest, Rib Fractures, Thoracic Injuries, Pulmonary Contusion, Blunt Trauma
- Keywords
- Flail chest, Rib fractures, Pulmonary contusion, Multiple trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Caner İşevi, MDUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 1 Jan 2025 (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.
This study retrospectively investigates the causes of mortality and morbidity in patients undergoing rib fracture surgery due to blunt trauma. The primary objective is to determine whether pulmonary contusion or associated extrathoracic trauma plays a more significant role in adverse outcomes. Data collected includes patient demographics, trauma mechanisms, associated injuries, surgical timing, and clinical outcomes. The study aims to provide insights into improving management strategies for trauma patients and reducing complication rates through early identification and tailored interventions.
Detailed description
This retrospective study investigates the underlying causes of morbidity and mortality in patients who underwent rib stabilization surgery due to blunt trauma-induced rib fractures. The primary objective is to determine whether pulmonary contusion or associated extrathoracic trauma plays a more significant role in adverse outcomes such as pneumonia, prolonged air leaks, tracheostomy, wound infections, and mortality.
The study includes patients diagnosed with flail chest who underwent rib stabilization surgery between January 1, 2014, and January 1, 2024, at a single tertiary care center. Collected data encompasses patient demographics, trauma mechanisms, associated injuries (thoracic and extrathoracic), surgery timing (early vs. late stabilization), ventilator settings, extubation duration, intensive care unit (ICU) and hospital length of stay, laboratory parameters, and clinical outcomes.
Key outcomes include the incidence of morbidity (e.g., pneumonia, prolonged air leak, wound infections) and mortality. Statistical analyses will evaluate the relationship between these outcomes and factors such as the severity and timing of injuries, surgery timing, trauma mechanisms, and associated injuries.
The study aims to provide valuable insights into optimizing the management of flail chest patients, emphasizing the importance of early rib stabilization and a multidisciplinary approach. These findings are expected to contribute to the development of standardized protocols for patient selection and intervention timing, potentially improving patient outcomes in multitrauma settings.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with blunt trauma-induced rib fractures leading to flail chest, treated with rib stabilization surgery in a hospital setting.
Key inclusion criteria (3 listed)
- Patients aged 18-80 years diagnosed with flail chest following blunt trauma who underwent rib stabilization surgery
- Those with complete clinical and laboratory data
- Those with at least 30 days of follow-up after surgery.
Key exclusion criteria (4 listed)
- Patients under 18 years of age
- Flail chest patients who did not require rib stabilization surgery
- Patients with incomplete clinical or laboratory data
- Those with penetrating thoracic trauma.
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 |
|---|---|---|
| Rib fractures manangementThis is an observational study, so participants are not assigned interventions. However, the study investigates the outcomes of patients undergoing rib stabilization surgery as part of their routine clinical care. The exposure of interest includes surgical rib stabilization and its timing, combined with any related clinical and care procedures. The outcomes and clinical data collected reflect routine care practices. | Other | – |
Primary outcome
Mortality Rate in Patients Undergoing Rib Stabilization Surgery
Time frame: Within 30 days post-surgery
The primary outcome measure is the overall mortality rate among patients with flail chest due to blunt trauma, treated with rib stabilization surgery. The analysis will focus on the association between mortality and factors such as trauma severity and associated injuries.
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 1 Jan 2025.
Related trials for Flail Chest
Not yet recruiting
Surgery for Unstable Chest Wall Injuries - How Many Fractures Should be Fixed?
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Recruiting
UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture
Rib Fractures, Rib Fracture Multiple
RecruitingObservational study
RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures
Rib; Fracture
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Flail Chest and Rib Fractures, run by Caner İşevi, MD.
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 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: finished, as of the sponsor's last update on 1 Jan 2025. 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?
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?
Mortality Rate in Patients Undergoing Rib Stabilization Surgery (time frame: Within 30 days post-surgery). 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 1 Jan 2025.