跳至主要内容
临床试验/NCT02132416
NCT02132416已完成不适用

Prospective Controlled Study of Surgical Management of Unstable Thoracic Cage Injuries and Chest Wall Deformity in Trauma

Sahlgrenska University Hospital, Sweden2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
92
试验地点
2
主要终点
Respiratory insufficiency

研究概览

简要总结

The purpose of this prospective controlled study is to determine whether surgical management of unstable thoracic cage injuries and chest wall deformity in trauma reduces the need for and the time spent on ventilator compared to a group treated without operation.

详细描述

Patients meeting the inclusion criteria and giving their informed consent will be enrolled in this prospective controlled study. Included patients at Sahlgrenska University Hospital will undergo surgical stabilization of chest wall injuries and patients at Karolinska University Hospital will be managed conservatively. A total of 60 patients will be included in each group. 3D reconstructions of computed tomography images of the Thorax done at admission to the hospital will be used in order to evaluate injury according to Lung Injury Scale and Chest wall Injury Scale and for calculating radiological lung volumes and plan surgical procedure in the intervention group. Surgery will be performed as soon as possible after inclusion. MatrixRIB® (DePuy Synthes) Fixation system is used for stabilizing rib fractures with plates and angular locked screws. In cases where thoracotomy is done the patients will receive an anterior and posterior chest tube and wound drain with active suction. All patients, both in the intervention and in the control group will be offered thoracic epidural anaesthesia. Broad-spectrum intravenous antibiotic therapy is given as long as the patient has chest tubes. Thrombotic prophylaxis with LMWH is given until the patient is mobilized but for a minimum of 7 days. Patients will be followed-up 6 weeks, 6 months and 1 year post-operatively by surgeon and physiotherapist. A low-dosage computer tomography of the thorax will be done after 6 months in order to evaluate healing of the rib cage, possible non-union or dysfunction of osteosynthetic material and measure remaining lung volume. This examination will be compared to the initial computer tomography image done when the patient was admitted. At follow-ups complaints, possible late complications, usage of analgesia and return to work will be recorded. Evaluated instruments, EQ-5D-5L, VAS with Pain-O-Meter (POM) and Disability Rating Index (DRI) will be used to evaluate quality of life, pain and physical function. Range of motion in the thorax, thoracic spine and shoulders will be evaluated for every patient. Breathing movements will be measured by using a Respiratory movement measuring instrument (RMMI, ReMo Inc) and lung function tests will be performed in a standardized manner.

In order to enrich the material, hospital data from patients fulfilling the inclusion criteria but not included, at the two study locations, during the inclusion period (June 2014 - June 2017) will be analyzed. An additional Ethical approval has been granted.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Trauma with segmental rib fractures on at least 3 adjacent ribs ( anatomical flail chest )
  • Trauma with chest wall deformity

排除标准

  • Concurrent spinal cord injuries with paralysis
  • Severe head injury where normal level of consciousness is not resumed
  • Severe neurological and musculoskeletal diseases that influence the function of the thoracic wall and lung volumes

研究组 & 干预措施

Surgical management

Active Comparator

Operative fixation of unstable thoracic cage injuries and chest wall deformity. Thoracic Epidural anaesthesia will be offered. Paracetamol, Opioids and NSAID will be used as pain medication.

干预措施: NSAID (Drug)

Surgical management

Active Comparator

Operative fixation of unstable thoracic cage injuries and chest wall deformity. Thoracic Epidural anaesthesia will be offered. Paracetamol, Opioids and NSAID will be used as pain medication.

干预措施: Opioids (Drug)

Surgical management

Active Comparator

Operative fixation of unstable thoracic cage injuries and chest wall deformity. Thoracic Epidural anaesthesia will be offered. Paracetamol, Opioids and NSAID will be used as pain medication.

干预措施: Thoracic Epidural anaesthesia (Drug)

Surgical management

Active Comparator

Operative fixation of unstable thoracic cage injuries and chest wall deformity. Thoracic Epidural anaesthesia will be offered. Paracetamol, Opioids and NSAID will be used as pain medication.

干预措施: Paracetamol (Drug)

Surgical management

Active Comparator

Operative fixation of unstable thoracic cage injuries and chest wall deformity. Thoracic Epidural anaesthesia will be offered. Paracetamol, Opioids and NSAID will be used as pain medication.

干预措施: Surgical management (Procedure)

Conservative management

Active Comparator

Conservative management of unstable thoracic cage injuries and chest wall deformity. Thoracic epidural anaesthesia will be offered. Paracetamol, Opioids and NSAID will be used as pain medication.

干预措施: NSAID (Drug)

Conservative management

Active Comparator

Conservative management of unstable thoracic cage injuries and chest wall deformity. Thoracic epidural anaesthesia will be offered. Paracetamol, Opioids and NSAID will be used as pain medication.

干预措施: Opioids (Drug)

Conservative management

Active Comparator

Conservative management of unstable thoracic cage injuries and chest wall deformity. Thoracic epidural anaesthesia will be offered. Paracetamol, Opioids and NSAID will be used as pain medication.

干预措施: Thoracic Epidural anaesthesia (Drug)

Conservative management

Active Comparator

Conservative management of unstable thoracic cage injuries and chest wall deformity. Thoracic epidural anaesthesia will be offered. Paracetamol, Opioids and NSAID will be used as pain medication.

干预措施: Paracetamol (Drug)

结局指标

主要结局

Respiratory insufficiency

时间窗: 1 year

Need and length of ventilation therapy

次要结局

  • Hospital stay(6 weeks)

研究者

发起方
Sahlgrenska University Hospital, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eva-Corina Caragounis

MD

Sahlgrenska University Hospital, Sweden

研究点 (2)

Loading locations...

相似试验