Percutaneous Cryoablation of Intercostal Nerves for the Treatment of Rib Fractures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Rate of abnormal respiratory mechanics: Incentive Spirometry
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •> 18 years old
- •> 2 rib fractures
- •Verbal Pain score > 5
- •Incentive Spirometry < 60% of predicted
排除标准
- •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
研究组 & 干预措施
Standard multi-modal pain regimen alone
干预措施: Multi-modal pain regimen (Other)
Standard multi-modal pain regimen with percutaneous cryoablation
干预措施: Percutaneous Cryoablation of Intercostal Nerves (Procedure)
Standard multi-modal pain regimen with percutaneous cryoablation
干预措施: Multi-modal pain regimen (Other)
结局指标
主要结局
Rate of abnormal respiratory mechanics: Incentive Spirometry
时间窗: Through study completion, up to 1 year
Pain Score: Numeric Pain Scale
时间窗: 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 delirium: Confusion Assessment Method (CAM) Score
时间窗: 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
Rate of abnormal respiratory mechanics: Pulmonary Function Tests
时间窗: 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)
Quality of Life on Survey
时间窗: Through study completion, up to 1 year
Long Term Quality of Life
次要结局
- Rate of need for tracheostomy(Through study completion, up to 1 year)
- ICU Length of Stay(Through study completion, up to 1 year)
- Acute Respiratory Distress Syndrome(Through study completion, up to 1 year)
- Rate of Pneumonia(Through study completion, up to 1 year)
- Rate of need for Intubation/Mechanical Ventilation(Through study completion, up to 1 year)
- Hospital Length of Stay(Through study completion, up to 1 year)
- Number of Ventilatory Days(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)