Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures
NCT Number: NCT06533904
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Trauma|Rib Fractures|Chest Wall Disorder|Respiratory Insufficiency|Pain, Chest|Rib Trauma|Rib Fracture Multiple|Respiratory Failure|Respiratory Distress Syndrome
Interventions: DEVICE: Percutaneous Cryoablation of Intercostal Nerves|OTHER: Multi-modal pain regimen
Sponsor: Loma Linda University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-31
Completion Date: 2026-07-31
Locations: Loma Linda University Health, Loma Linda, California, 92354, United States

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.

Primary Outcome Measures: 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
Secondary Outcome Measures: 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, Hemothorax, Delayed hemothorax, Pneumothorax, Empyema, Hydrothorax, Rate of tube thoracostomy, Through study completion, up to 1 year