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

ConditionsRib Fractures Blunt Chest Trauma Thoracic Injuries Pulmonary Complications

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorCaner İşevi, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Standard Analgesic Therapy
Other intervention
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
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.

Treatment groups

74 Participants

are divided into 2 treatment groups

Group A: Standard Analgesic TreatmentActive comparator 1 intervention

Group B: Innovative Chest StabilizerExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Change in Numeric Rating Scale (NRS) Pain Score From Baseline to 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.

Time frame

Baseline and Day 10

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Caner İşevi, MD

Lead sponsor

Ondokuz Mayıs University

Sponsor institution

Ondokuz Mayıs University

Collaborator

Source ClinicalTrials.gov

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