Sonography After Thoracic Surgery - SATS (CT0011)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- US post thoracic surgery will be measured against CXR in the detection of pneumothorax/pleural effusion. Decisions will be made regarding chest tube removal during rounds, alleviate the need for more CXR as well as decrease patient length of stay.
研究概览
简要总结
Lung cancer remains the leading cause of mortality from malignant diseases in both men and women worldwide. Following thoracic surgery and pulmonary resection, patients have a surgically induced pneumothorax / hydro-hemothorax and hence tube thoracostomy is necessary to drain the air and effusion. Due to this, patients must undergo post-operative chest x-ray (CXR) evaluations in order to evaluate the chest and make decisions regarding removal of chest tubes (CT) as well as for decisions regarding patient discharge. Thoracic Ultrasound (US) has been shown to be accurate at diagnosing pneumothorax and has been well-studied in the trauma population. To the investigators knowledge, there are currently no centers using thoracic US routinely in the post-operative setting following thoracic surgery.
详细描述
Following thoracic surgery (both open and thoracoscopic) patients have a surgically induced pneumothorax and hence tube thoracostomy is needed to drain the air and effusion. Due to this, patients must undergo post operative chest x-ray (CXR) evaluations in order to evaluate the chest and make decisions regarding removal of chest tubes as well as for decisions regarding patient discharge. Following chest tube removal, most surgeons advocate further CXR evaluation to assure that no pneumothorax was introduced during removal of the tube.
Repetitive CXR evaluations are costly, inconvenient, expose the patient and healthcare worker to repetitive radiation, and require time. Surgeon-performed US could be performed as an adjunct to physical examination. This would allow surgeons to make decisions regarding chest tube removal during rounds, alleviate the need for most CXRs as well as decrease patient length of stay. The goals of this project is to: evaluate the reliability and accuracy of surgeon-performed US following thoracic surgery, and evaluate the potential improved convenience for patients and the healthcare system using surgeon-performed US.
US technology has traditionally been the domain of the radiologist; however, recently US has evolved into an important tool for the clinician, similar to the stethoscope of the past, which can be utilized in an organ and specialty specific manner. Users of US in clinical care on a daily basis for specialty specific indications are: cardiologists, gastroenterologists, anesthesiologists, OBGYN, trauma, breast, ENT, hepatobiliary, and colorectal surgeons. US technology has yet to find its place in the domain of the thoracic surgeon and in the diagnosis and treatment of pulmonary malignancy, although there are many potential important applications for its use. We believe that portable hand-held ultrasound may be the thoracic surgeon's stethoscope of the future.
Thoracic ultrasound has been shown to be accurate at diagnosing pneumothorax (sensitivity, specificity = 90%) and has been well studied in the trauma population (sensitivity 95%) , however, few studies have been done using thoracic ultrasound in the non-injured population . To our knowledge, there are currently no centers using thoracic ultrasound routinely in the post-operative setting following general thoracic surgery.
Buzzas et al. showed that surgeons and surgical residents performing focused abdominal sonography for the initial evaluation of trauma patients were able to correctly diagnose injuries as safely and accurately as radiologists . Sensitivity, specificity, accuracy and negative predictive values were not significantly different between the surgeon and radiologist groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective, open and thoracoscopic thoracic surgery for any indication
排除标准
- •Age < 18 years old
- •Inability to consent for the study
- •Chest wall anatomy precluding SATS
- •Inability to sit upright
结局指标
主要结局
US post thoracic surgery will be measured against CXR in the detection of pneumothorax/pleural effusion. Decisions will be made regarding chest tube removal during rounds, alleviate the need for more CXR as well as decrease patient length of stay.
时间窗: on a daily basis
Surgeon performed ultrasound will be compared to plain film CXR, which is considered the "gold standard". If the result of this study show that surgeon performed US is accurate and sensitive in the evaluation of post-operative thoracic surgery patients, US could replace CXR in the post-operative care of these patients
次要结局
未报告次要终点
