Effectiveness of an Innovative Chest Stabilizer in Rib Fracture Treatment: Impact on Respiratory Function, Complications, and Clinical Outcomes

NCT ID: NCT07238582

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-12-01

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.

Conditions

Rib Fractures; Blunt Chest Trauma; Thoracic Injuries; Pulmonary Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Standard Analgesic Therapy

Intervention Type: OTHER

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.

Innovative Chest Stabilizer

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Standard Analgesic Therapy

Intervention Type: OTHER

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.

Interventions

Standard 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.

Intervention Type: OTHER

Innovative 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.

Intervention Type: DEVICE

Other Intervention Names

Non-Invasive Chest Wall Stabilizer

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: collaborator

Caner İşevi, MD

OTHER

Sponsor Role: lead

Responsible Party

Caner İşevi, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ondokuz Mayis University Medical Faculty, Department of Thoracic Surgery

Samsun, Samsun, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

B.30.2.ODM.0.20.08/ 715-779

Identifier Type: -

Identifier Source: org_study_id