Effectiveness of an Innovative Chest Stabilizer in the Treatment of Rib Fractures: Impact on Respiratory Function, Complications, and Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change in Numeric Rating Scale (NRS) Pain Score From Baseline to Day 10
研究概览
简要总结
This study aims to evaluate the effectiveness of an innovative, non-invasive chest stabilizer in patients with multiple rib fractures caused by blunt chest trauma. Rib fractures often lead to severe pain, breathing difficulties, and complications such as pneumonia or atelectasis. Participants will be randomly assigned to one of two groups: standard pain management or the new chest stabilizer, which will be used for 10 days.
The study will assess improvements in pain levels, breathing function (including FVC, FEV1, and PEF), and the occurrence of lung-related complications. Additional outcomes such as hospital stay, patient comfort, and skin reactions related to the device will also be evaluated. The goal of this research is to determine whether the innovative stabilizer can provide safer, more comfortable, and more effective treatment compared with current standard care for rib fracture patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will not be informed about whether they receive standard treatment alone or the innovative chest stabilizer in addition to standard care.
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
- 否
入选标准
- •Adults aged 18 to 80 years. Blunt chest trauma with at least three rib fractures confirmed by imaging. Numeric Rating Scale (NRS) pain score ≥ 5 at rest, during deep inspiration, or with movement.
- •Able to perform spirometry reliably (FVC, FEV1, PEF). Hemodynamically stable and medically suitable for participation. Able and willing to provide informed consent.
排除标准
- •Age younger than 18 or older than 80 years. Penetrating chest trauma. Patients who have undergone surgical rib fixation. Active pneumonia, clinically significant atelectasis, or severe pulmonary infection at admission.
- •Uncontrolled cardiovascular, renal, or hepatic disease. Severe cognitive impairment, psychiatric disorders, or inability to comply with study procedures.
- •Severe respiratory failure requiring invasive mechanical ventilation. Skin infection, open wounds, or dermatologic conditions preventing stabilizer application.
- •Coagulopathy or contraindications to external chest compression. Pregnancy. Refusal or inability to give informed consent.
研究组 & 干预措施
Standard Analgesic Treatment
Participants in this arm will receive standard pain management for rib fractures according to institutional clinical protocols. Treatment may include non-opioid or opioid analgesics, muscle relaxants, and supportive respiratory measures as clinically indicated. No chest stabilizer device will be applied.
干预措施: Standard Analgesic Therapy (Other)
Innovative Chest Stabilizer
Participants in this arm will receive standard analgesic treatment plus an innovative, non-invasive chest stabilizer. The stabilizer will be applied on the day of admission and used continuously for 10 days. Standard care includes routine analgesic medications administered according to institutional protocols. The chest stabilizer is designed to reduce pain, improve chest wall support, enhance respiratory mechanics, and potentially decrease pulmonary complications such as pneumonia or atelectasis.
干预措施: Standard Analgesic Therapy (Other)
Innovative Chest Stabilizer
Participants in this arm will receive standard analgesic treatment plus an innovative, non-invasive chest stabilizer. The stabilizer will be applied on the day of admission and used continuously for 10 days. Standard care includes routine analgesic medications administered according to institutional protocols. The chest stabilizer is designed to reduce pain, improve chest wall support, enhance respiratory mechanics, and potentially decrease pulmonary complications such as pneumonia or atelectasis.
干预措施: Innovative Chest Stabilizer (Device)
结局指标
主要结局
Change in Numeric Rating Scale (NRS) Pain Score From Baseline to Day 10
时间窗: Baseline and Day 10
Pain intensity will be assessed using the 0-10 Numeric Rating Scale (NRS). Participants will report their pain score at rest and during deep inspiration on the day of admission (baseline) and again on Day 10. The outcome is the change in NRS score from baseline to Day 10. A greater reduction in NRS score indicates improved pain control. This outcome evaluates the primary clinical effect of the innovative chest stabilizer compared with standard analgesic treatment.
次要结局
未报告次要终点
研究者
Caner İşevi, MD
Principal Investigator
Ondokuz Mayıs University