Rib FracturesNCT07238582
Effectiveness of an Innovative Chest Stabilizer in Rib Fracture Treatment: Impact on Respiratory Function, Complications, and Clinical Outcomes
A study testing Standard Analgesic Therapy and Innovative Chest Stabilizer in people with Rib Fractures and Blunt Chest Trauma, run by Caner İşevi, MD at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rib Fractures, Blunt Chest Trauma, Thoracic Injuries
- What is being tested?
- Standard Analgesic Therapy and Innovative Chest Stabilizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University Medical Faculty, Department of Thoracic Surgery
Samsun, Samsun, 55139
About this study
Official title: Effectiveness of an Innovative Chest Stabilizer in the Treatment of Rib Fractures: Impact on Respiratory Function, Complications, and Clinical Outcomes
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.
- Being tested
- Standard Analgesic Therapy, Innovative Chest Stabilizer
- Medical subject headings
- Rib Fractures, Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Analgesic TherapyOther
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 StabilizerDevice
Also called Non-Invasive Chest Wall 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Analgesic Treatment | Active comparator | 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. Receives: Other: Standard Analgesic Therapy |
| Innovative Chest Stabilizer | Experimental | 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. Receives: Other: Standard Analgesic Therapy; Device: Innovative Chest Stabilizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Dec 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups: standard analgesic treatment or innovative chest stabilizer application.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caner İşevi, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Responsible party
- Sponsor-investigator, Caner İşevi, MD, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238582
- Sponsor's protocol ID
- B.30.2.ODM.0.20.08/ 715-779
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data because the study data will be used only for the primary analysis within the research team. De-identified datasets may be shared in the future upon reasonable request and after appropriate ethics review.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Innovative Chest Stabilizer in the Treatment of Rib Fractures: Impact on Respiratory Function, Complications, and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07238582
- Acronym / sponsor ID
- B.30.2.ODM.0.20.08/ 715-779
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Caner İşevi, MDUniversity, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups: standard analgesic treatment or innovative chest stabilizer application.
| Arm | Type | Receives |
|---|---|---|
| Standard Analgesic Treatment | Active comparator | Other: Standard Analgesic TherapyParticipants 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. |
| Innovative Chest Stabilizer | Experimental | Other: Standard Analgesic Therapy, Device: Innovative Chest StabilizerParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Analgesic TherapyStandard 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. | Other | Innovative Chest Stabilizer, Standard Analgesic Treatment |
| Innovative Chest StabilizerAlso: Non-Invasive Chest Wall StabilizerA 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. | Device | Innovative Chest Stabilizer |
Primary outcome
Change in Numeric Rating Scale (NRS) Pain Score From Baseline to Day 10
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data because the study data will be used only for the primary analysis within the research team. De-identified datasets may be shared in the future upon reasonable request and after appropriate ethics review.
Related trials for Rib Fractures
RecruitingPhase 4
INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures
Rib Fractures
Recruiting
Erector Spinae Plane vs Serratus Anterior Plane Catheter Infusions for Acute Pain Management in Patients With Traumatic Rib Fractures
Traumatic Rib Fracture(s), Traumatic Rib Fracture
Not yet recruitingPhase 2/3
Comparison of Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Erector Spinae Plane Block for Acute Pain Management in Patients With Traumatic Rib Fractures
Rib Fractures, Acute Pain
RecruitingObservational study
GNRI and PNI for Predicting Short-Term Outcomes in Older Adults With Multiple Rib Fractures
Multiple Rib Fractures, Isolated Blunt Thoracic Trauma
Recruiting
Parascapular Sub Iliocostalis Plane Block Versus Thoracic Paravertebral Plane Block for Traumatic Multiple Rib Fractures
Discitis of Thoracic Region
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Analgesic Therapy and Innovative Chest Stabilizer in people with Rib Fractures and Blunt Chest Trauma, run by Caner İşevi, MD at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numeric Rating Scale (NRS) Pain Score From Baseline to Day 10 (time frame: Baseline and Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.