Chest Wall Disorder, Pain, Chest, Respiratory Distress Syndrome, Respiratory Failure, Respiratory Insufficiency, Rib Fracture Multiple, Rib Fractures, Rib Trauma, Trauma
Conditions
Keywords
Trauma, Respiratory Failure, Respiratory Distress, Respiratory Insufficiency, Rib Fractures, Chest Wall Trauma, Percutaneous Cryoablation, Multimodal Pain Therapy, Multimodal Pain Regimen
Brief summary
The goal of this double blinded randomized control trial is to learn if percutaneous cryoablation of traumatic rib fractures improves outcomes. The main questions it aims to answer are: Does percutaneous cryoablation improve short and long term pain scores? Does percutaneous cryoablation improve short and long term respiratory mechanics? Does percutaneous cryoablation improve long term quality of life? Does percutaneous cryoablation decrease delirium? Researchers will compare cryoablation to standard multimodal pain therapy to see if this impacts respiratory recovery. Participants will undergo randomization, percutaneous cryoablative procedure, and participate in tests at pre-determined intervals to evaluate their pulmonary recovery.
Interventions
PROCEDUREPercutaneous Cryoablation of Intercostal Nerves
Percutaneous Cryoablation of Intercostal Nerves
OTHERMulti-modal pain regimen
Standard rib fracture protocol including cyclooxygenase inhibitors, anti-neuropathic, muscle relaxers, short term anesthesia interventions (percutaneous block, epidural)
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Patients will be randomized to standard multi-modal pain regimen with percutaneous cryoablation versus standard multi-modal pain regimen alone.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* \> 18 years old * \> 2 rib fractures * Verbal Pain score \> 5 * Incentive Spirometry \< 60% of predicted
Exclusion criteria
* Isolated Fractures of Ribs 1-3 and/or 10-12 * Posterior Rib Fracture \< 4 cm from costovertebral joint * Sternal, Clavicle, Scapula Fracture * Thoracic Spinal Fracture of any type * Open Abdominothoracic Surgery * Unstable Spine * Extensive Subcutaneous Emphysema * BMI \> 35 * Plan for Rib Plating * Chronic Opioid Use * Prior to study enrollment: Intubated, Traumatic Brain Injury, Dementia, Cognitive Impairment, Encephalopathy * Coagulopathy, Shock at time of ablation * Inability to participate in activities of daily living prior to injury * Home O2 use prior to trauma * Inhalation Injury * Rib Fractures due to cardiopulmonary resuscitation * Life Expectancy \< 6 months * \> 48 hours from injury * Pregnant, Incarcerated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score: Numeric Pain Scale | Through study completion, up to 1 year | Short and Long Term Pain Scores. Range from 0 to 10 where 0 is no pain and 10 is most severe and worse outcome. |
| Rate of abnormal respiratory mechanics: Incentive Spirometry | Through study completion, up to 1 year | — |
| Rate of abnormal respiratory mechanics: Pulmonary Function Tests | Through study completion, up to 1 year | Short and Long Term Respiratory Mechanics. Pulmonary Function Tests will specifically measure Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC) |
| Rate of delirium: Confusion Assessment Method (CAM) Score | Through study completion, up to 1 year | The score ranges from 0 to 19. Where higher scores indicate more severe delirium and low scores indicate less severe or no delirium |
| Quality of Life on Survey | Through study completion, up to 1 year | Long Term Quality of Life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Pneumonia | Through study completion, up to 1 year | — |
| Rate of need for Intubation/Mechanical Ventilation | Through study completion, up to 1 year | — |
| Rate of need for tracheostomy | Through study completion, up to 1 year | — |
| Number of Ventilatory Days | Through study completion, up to 1 year | — |
| ICU Length of Stay | Through study completion, up to 1 year | — |
| Hospital Length of Stay | Through study completion, up to 1 year | — |
| Acute Respiratory Distress Syndrome | Through study completion, up to 1 year | — |
| Rate of Mortality | Through study completion, up to 1 year | — |
| Rate of Pleural Space Complications | Through study completion, up to 1 year | Hemothorax, Delayed hemothorax, Pneumothorax, Empyema, Hydrothorax, Rate of tube thoracostomy |
Countries
United States
Outcome results
None listed