Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405841
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-04
Brief Title:
Costal Fracture Assessment for Relief and Enhancement of Quality of Life
Sponsor:
Ospedali Riuniti Trieste
Organization:
Ospedali Riuniti Trieste
Study Overview
Official Title:
Costal Fracture Assessment for Relief and Enhancement of Quality of Life - CARE Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARE
Brief Summary:
This study explores the impact of rib fractures on patient well-being and quality of life aiming to identify effective interventions for pain relief and functional improvement It investigates the long-term outcomes of conservative treatment for rib fractures analyzing factors such as analgesic therapy hospitalization duration and respiratory infection rates Anticipated results include a comprehensive assessment of patient quality of life and the potential translational implications for healthcare practice Furthermore the study aims to inform healthcare resource optimization potentially guiding treatment decisions and improving patient outcomes within the National Health Service
Detailed Description:
Thoracic trauma remains a significant cause of morbidity and mortality in the traumatized population Rib fractures are the most commonly encountered injuries after thoracic trauma accounting for approximately 10-15 of all trauma-related hospital admissions Fractured ribs serve as surrogate indicators of severe injuries as most patients suffer additional critical injuries Rib fractures are associated with significant long-term morbidity and disability resulting in enduring physical impairment dyspnea and delayed return to normal daily and work activities leading to decreased quality of life Additionally previous studies have demonstrated that up to a quarter of patients with rib fractures experience persistent chest pain even one year or more after the trauma In current clinical practice surgical treatment of rib fractures is increasingly common as restoring chest wall integrity appears to alleviate pain and preserve normal breathing mechanics While recent studies suggest that rib fracture fixation may improve lung function reduce pulmonary complication rates and shorten hospitalization and intensive care unit ICU stays in selected patients a definitive consensus on which patients should undergo surgery has yet to be established Contributing to the difficulty in determining optimal treatment for patients with rib fractures is the limited research on long-term quality of life and functional outcomes after rib fracture fixation or conservative management Therefore this study aims to investigate the quality of life of patients with rib fractures treated conservatively using a dedicated questionnaire and evaluate the type of analgesic medical therapy used length of hospital stay and rate of respiratory infections
Expected Results Translatability and Impact on the National Health Service SSN
Expected Results It is anticipated that the study will provide a detailed assessment of the quality of life of patients with rib fractures treated conservatively and their long-term quality of life Additionally the study aims to identify the most effective types of analgesic medical therapies in controlling rib fracture-related pain as well as the duration of hospitalization and rate of respiratory infections associated with conservative treatment
Translatability The study results could have broad practical applications in the healthcare sector providing guidance on best practices for rib fracture treatment This could lead to greater efficacy in rib fracture management protocols reducing or increasing the need for surgical interventions to improve patient quality of life
Impact on the National Health Service SSN The study could have a significant impact on the SSN by providing evidence to optimize healthcare resources through more targeted management of rib fractures If the results demonstrate that conservative treatment is ineffective for certain types of rib fractures as it entails a longer hospital stay with very late return to daily and work activities these patients could be selected for surgical treatment resulting in savings for the SSN and an improvement in patient quality of life
Expected Results Translatability and Impact on the National Health Service SSN
Expected Results It is anticipated that the study will provide a detailed assessment of the quality of life of patients with rib fractures treated conservatively and their long-term quality of life Additionally the study aims to identify the most effective types of analgesic medical therapies in controlling rib fracture-related pain as well as the duration of hospitalization and rate of respiratory infections associated with conservative treatment
Translatability The study results could have broad practical applications in the healthcare sector providing guidance on best practices for rib fracture treatment This could lead to greater efficacy in rib fracture management protocols reducing or increasing the need for surgical interventions to improve patient quality of life
Impact on the National Health Service SSN The study could have a significant impact on the SSN by providing evidence to optimize healthcare resources through more targeted management of rib fractures If the results demonstrate that conservative treatment is ineffective for certain types of rib fractures as it entails a longer hospital stay with very late return to daily and work activities these patients could be selected for surgical treatment resulting in savings for the SSN and an improvement in patient quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None