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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard multi-modal pain regimen alone | Placebo Comparator |
| |
| Standard multi-modal pain regimen with percutaneous cryoablation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Cryoablation of Intercostal Nerves | Procedure | Percutaneous Cryoablation of Intercostal Nerves |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score: Numeric Pain Scale | Short and Long Term Pain Scores. Range from 0 to 10 where 0 is no pain and 10 is most severe and worse outcome. | Through study completion, up to 1 year |
| Rate of abnormal respiratory mechanics: Incentive Spirometry | Through study completion, up to 1 year | |
| Rate of abnormal respiratory mechanics: Pulmonary Function Tests | Short and Long Term Respiratory Mechanics. Pulmonary Function Tests will specifically measure Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC) | Through study completion, up to 1 year |
| Rate of delirium: Confusion Assessment Method (CAM) Score | The score ranges from 0 to 19. Where higher scores indicate more severe delirium and low scores indicate less severe or no delirium | Through study completion, up to 1 year |
| Quality of Life on Survey | Long Term Quality of Life | Through study completion, up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Health | Loma Linda | California | 92354 | United States |
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Patients will be randomized to standard multi-modal pain regimen with percutaneous cryoablation versus standard multi-modal pain regimen alone.
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| Multi-modal pain regimen | Other | Standard rib fracture protocol including cyclooxygenase inhibitors, anti-neuropathic, muscle relaxers, short term anesthesia interventions (percutaneous block, epidural) |
|
| 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 | Hemothorax, Delayed hemothorax, Pneumothorax, Empyema, Hydrothorax, Rate of tube thoracostomy | Through study completion, up to 1 year |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D012253 | Rib Fractures |
| D012131 | Respiratory Insufficiency |
| D002637 | Chest Pain |
| D012128 | Respiratory Distress Syndrome |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D013898 | Thoracic Injuries |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
| D012818 | Signs and Symptoms, Respiratory |
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