- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06755723
Mortality Causes in Rib Surgery Patients
The Underlying Cause of Mortality and Morbidity in Patients Undergoing Rib Fracture Surgery: Pulmonary Contusion or Associated Extrathoracic Trauma?
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Within 30 days post-surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B.30.2.ODM.0.20.08/713
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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