Blunt Chest Trauma, Pulmonary Complications, Rib Fractures, Thoracic Injuries
Conditions
Brief summary
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.
Interventions
OTHERStandard Analgesic Therapy
Standard analgesic therapy provided according to institutional protocols for the management of rib fracture-related pain. Treatment may include routinely administered non-opioid or opioid analgesics and supportive respiratory care as clinically indicated. No chest stabilizer device is used in this intervention. This represents the standard of care and serves as the comparator for the study.
DEVICEInnovative Chest Stabilizer
A non-invasive chest wall stabilizing device applied on the day of hospital admission and used continuously for 10 days. The device is designed to reduce pain, improve chest wall support, enhance respiratory mechanics, and help prevent pulmonary complications such as pneumonia or atelectasis in patients with multiple rib fractures. The device is applied externally and does not require surgical intervention.
Sponsors
Ondokuz Mayıs University
Caner İşevi, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will not be informed about whether they receive standard treatment alone or the innovative chest stabilizer in addition to standard care.
Intervention model description
Participants will be randomly assigned to one of two parallel groups: standard analgesic treatment or innovative chest stabilizer application.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Numeric Rating Scale (NRS) Pain Score From Baseline to Day 10 | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed