Surgical Stabilization for Rib Fractures

Not Applicable

Completed

Conditions: Trauma Chest
Rib Fracture Multiple

Interventions: Procedure: Usual care
Procedure: surgical stabilization

Registration Number: NCT04081233

Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary: The purpose of this study is to compare the usual care alone to usual care plus early surgical stabilization in adult trauma patients who have been admitted with rib fractures, to evaluate for heterogeneity of treatment effect in high risk subgroups and to determine the the impact of multiple rib fractures on post-discharge health status and time to return to work or usual physical activity.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 84

Inclusion Criteria

Blunt trauma mechanism
Severe chest wall injury (defined by one of the 3 below):

Radiographic flail segment (defined as greater than 2 fractures in greater than 3 consecutive ribs) or greater than 5 consecutive rib fractures or greater than 1 rib fractures with bicortical displacement

At least one true rib (1-7) fractured and accessible for stabilization

Exclusion Criteria

Severe traumatic brain injury (best resuscitated GCS less than 8 as measured at 24 hours)
Spinal cord injury
Pre-existing congestive heart failure or oxygen-dependent pulmonary disease
Any reason for which SSRF could not occur within 72 hours of admission

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	This arm will be usual care only. Usual care will include pain managment.
Early surgical stabilization	surgical stabilization	This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.

Primary Outcome Measures

Name	Time	Method
Hospital Length of Stay	180 days after admission	Number of days patient is in the hospital

Secondary Outcome Measures

Name	Time	Method
Number of Participants Prescribed Opioids at Discharge	Hospital discharge (about 20 to 30 days)
Number of Participants Back to Work or Normal Physical Activity	180 days post admission
Incidence of Respiratory Failure Requiring Mechanical Ventilation Greater Than 24 Hours	24 hours after hospital admission	number of patients who require mechanical ventilation greater than 24 hours
Opioid Usage	Hospital discharge (about 20 to 30 days)	Opioid usage is reported in milligrams per patient from admission to discharge
Time From Injury to Return to Work	180 days post admission	Number of days from time of injury until patient was able to return to work prior to injury per patient's assessment
Number of Patients Who Developed Pneumonia During the Hospitalization	6 months after admission	Number of patients diagnosed with pneumonia with greater than 10,000 cfu/ml on bronchioalveolar lavage or clinical diagnosis of pneumonia with subsequent antibiotic coverage
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L	180 days post admission	Level of impairment will be assessed for five dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression) by using the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). Each dimension is rated at five levels: no impairment (1); minor impairment (2); moderate impairment (3); severe impairment (4); and extreme impairment (5). A higher score indicates a worse outcome.
Number of Patients Requiring Tracheostomy	Hospital discharge (about 20 to 30 days)	Number of patients requiring a tracheostomy due to prolonged mechanical ventilation
Number of Patients Who Received Regional Analgesia	6 months after admission	Number of patients utilizing regional analgesia, such as epidural, paravertebral, intercostal or serratus plane anesthesia
Ventilator Free Days	Hospital discharge (about 20 to 30 days)	Number of inpatient hospital days patients did not require mechanical ventilation
Re-intervention Rates for Surgical Complications	180 days post admission	The number of times a procedure was required to treat surgical complications
Time From Injury to Resolution of Pain	180 days post admission	Number of days from time of injury to time patient verbalized pain was resolved
Mortality	180 days after admission	Death following trauma injury involving rib fractures
Intensive Care Unit (ICU) Free Days	Hospital discharge (about 20 to 30 days)	Number of inpatient hospital days patient was not in ICU in the first 30 days
Hospital (ICU) Free Days	30 days post admission	Number of days patient was not in the hospital during the first 30 days after admission.
Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)	180 days post admission	Health status will be assessed by the Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L VAS score is directly reported by participants and ranges from 0 (the worst imaginable health) to 100 (the best imaginable health). A higher score indicates a better outcome.
Time From Injury to Return to Usual Activity	180 days post admission	Number of days from time of injury until patient was able to return to usual activities prior to injury per patient's assessment
Health Status as Assessed by Index Score on the Euroqol-5D-5L	180 days post admission	Health Status will be assessed by the index score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L index score ranges from 0 (a state as bad as being dead) to 1 (full health), and it is a summary score based on societal preference weights for the cumulative health states measured by 5 different dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression). It is calculated using the 2017 United States time trade-off valuation data set. A higher score indicates a better outcome.