Multiple Rib FracturesNCT07823712
GNRI and PNI for Predicting Short-Term Outcomes in Older Adults With Multiple Rib Fractures
An observational study of Multiple Rib Fractures and Isolated Blunt Thoracic Trauma, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational cohort study will evaluate whether the Geriatric Nutritional Risk Index (GNRI) and Prognostic Nutritional Index (PNI) can predict short-term clinical outcomes in adults aged 65 years or older with isolated blunt thoracic trauma and more than three rib fractures. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multiple Rib Fractures, Isolated Blunt Thoracic Trauma
- How many people
- 294 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Sep 2026to Sep 2027
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population will consist of adults aged 65 years or older presenting to the Emergency Department of Ankara Etlik City Hospital with isolated blunt thoracic trauma and more than three radiologically confirmed rib fractures. Eligible participants will be prospectively enrolled and followed during the index hospitalization and for 30 days after enrollment.
Who may be able to join
- Age 65 years or older.
- Presentation to the emergency department with blunt thoracic trauma.
- More than three rib fractures confirmed by thoracic computed tomography or another appropriate radiologic method.
- Isolated thoracic trauma without major extra-thoracic injury.
- Serum albumin level, total lymphocyte count, height, and weight available within the first 24 hours after presentation.
- Written informed consent obtained from the patient or the legally authorized representative.
Who cannot join
- Penetrating thoracic trauma.
- Single rib fracture.
- Intubation at presentation.
- Polytrauma or major extra-thoracic injury.
- Known advanced liver failure, nephrotic syndrome, end-stage renal disease, or hematologic disease that may substantially affect albumin or lymphocyte levels.
- Active malignancy or cachexia related to advanced malignancy.
- Missing data.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital, Department of Emergency Medicine
Ankara, Ankara, 06170
Tuğba Sanalp Menekşe, MD, 05514146422, tugba.sanalp@hotmail.com
Şeyda Nur Ünver, MD
About this study
Official title: Association of the Geriatric Nutritional Risk Index and Prognostic Nutritional Index With Short-Term Clinical Outcomes in Older Adults With Multiple Rib Fractures Presenting to the Emergency Department After Isolated Blunt Thoracic Trauma: A Prospective Observational Cohort Study
This prospective observational cohort study will evaluate whether the Geriatric Nutritional Risk Index (GNRI) and Prognostic Nutritional Index (PNI) can predict short-term clinical outcomes in adults aged 65 years or older with isolated blunt thoracic trauma and more than three rib fractures. Participants will be enrolled in the Emergency Department of Ankara Etlik City Hospital. No experimental drug, device, or additional invasive procedure will be used. Routine clinical, laboratory, anthropometric, imaging, and follow-up data will be recorded. The study plans to include 294 participants. The primary outcome is a composite short-term poor clinical outcome, including in-hospital mortality, intensive care unit admission, invasive or non-invasive mechanical ventilation, pneumonia, atelectasis, tube thoracostomy, or hospital stay of 7 days or longer. The prognostic performances of GNRI and PNI will be compared. Secondary outcomes include the individual components of the composite outcome, new pneumothorax or hemothorax, hospital and intensive care unit length of stay, 30-day emergency department revisit, and 30-day mortality.
Read the detailed description
Older adults with multiple rib fractures may have an increased risk of respiratory complications, intensive care admission, prolonged hospitalization, and mortality after thoracic trauma. Nutritional impairment may contribute to this risk through reduced respiratory muscle strength and impaired immune response. The Geriatric Nutritional Risk Index (GNRI) and Prognostic Nutritional Index (PNI) are practical nutritional assessment tools calculated from routinely available clinical and laboratory data.
This is a prospective, single-center, observational cohort study conducted in the Emergency Department of Ankara Etlik City Hospital. The study will include adults aged 65 years or older who present with isolated blunt thoracic trauma and more than three radiologically confirmed rib fractures. Patients will be evaluated during routine clinical care, and no additional treatment, medication, device, or invasive procedure will be administered for research purposes.
GNRI will be calculated using serum albumin, current body weight, and ideal body weight. PNI will be calculated using serum albumin and the total lymphocyte count. Height, weight, albumin, lymphocyte count, injury characteristics, associated thoracic findings, treatment requirements, hospital course, and clinical outcomes will be recorded prospectively.
The primary analysis will assess the association of GNRI and PNI with the composite short-term poor clinical outcome. The prognostic performances of the two indices will be evaluated using receiver operating characteristic curve analysis, area under the curve comparisons, and optimal cut-off values. Multivariable logistic regression analysis will be used to identify factors independently associated with the primary outcome. Hospital outcomes will be obtained from clinical records. Thirty-day emergency department revisit and mortality data will be obtained from available health records or, when necessary, by telephone follow-up.
- Keywords
- Geriatric Nutritional Risk Index, Prognostic Nutritional Index, Older Adults, Emergency Department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Cohort of Older Adults With Multiple Rib Fractures | Adults aged 65 years or older presenting to the emergency department with isolated blunt thoracic trauma and more than three radiologically confirmed rib fractures. Participants will be followed prospectively using routinely collected clinical, laboratory, anthropometric, imaging, treatment, and follow-up data. GNRI and PNI will be calculated and their associations with short-term clinical outcomes will be evaluated. No intervention is assigned; participants receive routine clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite In-Hospital Adverse Outcome in Older Adults With Multiple Rib Fractures
Occurrence within the index hospitalization or up to 30 days after enrollment of any of the following: in-hospital mortality; intensive care unit admission; invasive or non-invasive mechanical ventilation; pneumonia; atelectasis; chest tube placement due to pneumothorax or hemothorax; or total hospital length of stay of 7 days or longer.
Measured: From enrollment through discharge from the index hospitalization, or up to 30 days after enrollment, whichever occurs first.
Secondary outcomes (11)
Intensive Care Unit Admission
Admission to any intensive care unit during the index hospitalization after enrollment.
Measured: From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.
Invasive or Non-invasive Mechanical Ventilation
Initiation of invasive mechanical ventilation through endotracheal intubation or non-invasive ventilation with CPAP or BPAP during the index hospitalization after enrollment. The duration of mechanical ventilation will also be recorded.
Measured: From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.
Pneumonia
New-onset pneumonia during the index hospitalization, defined by a new radiologic pulmonary infiltrate accompanied by at least one clinical finding such as fever, leukocytosis, or purulent respiratory secretions.
Measured: From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.
Atelectasis
Newly developed atelectasis detected by chest radiography or chest computed tomography during the index hospitalization.
Measured: From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.
Tube Thoracostomy
Insertion of a chest tube for the treatment of pneumothorax or hemothorax during the index hospitalization.
Measured: From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.
New-onset Pneumothorax
Newly developed pneumothorax diagnosed during the index hospitalization after enrollment.
Measured: From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.
New-onset Hemothorax
Newly developed hemothorax diagnosed during the index hospitalization after enrollment.
Measured: From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.
Hospital Length of Stay
Total number of days from hospital admission to discharge or in-hospital death during the index hospitalization.
Measured: From hospital admission until discharge or in-hospital death, whichever occurs first, assessed up to 30 days after hospital admission.
30-Day Emergency Department Revisit
Any repeat visit to the emergency department within 30 days after discharge from the index hospitalization.
Measured: From discharge from the index hospitalization through 30 days after discharge.
30-Day Post-Discharge Mortality
Death from any cause within 30 days after discharge from the index hospitalization.
Measured: From discharge from the index hospitalization through 30 days after discharge.
In-Hospital Mortality
Death from any cause during the index hospitalization.
Measured: From enrollment through 30 days after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start16 Sep 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tugba Sanalp Menekse, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823712
- Sponsor's protocol ID
- AESH-BADEK1-2026-671
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. The dataset contains sensitive clinical information, and access will be restricted to the study investigators in accordance with the approved ethics protocol and participant confidentiality requirements. Only aggregate results will be reported.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of the Geriatric Nutritional Risk Index and Prognostic Nutritional Index With Short-Term Clinical Outcomes in Older Adults With Multiple Rib Fractures Presenting to the Emergency Department After Isolated Blunt Thoracic Trauma: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07823712
- Acronym / sponsor ID
- AESH-BADEK1-2026-671
- Keywords
- Geriatric Nutritional Risk Index, Prognostic Nutritional Index, Older Adults, Emergency Department
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 16 Sep 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 16 Sep 2026 (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 prospective observational cohort study will evaluate whether the Geriatric Nutritional Risk Index (GNRI) and Prognostic Nutritional Index (PNI) can predict short-term clinical outcomes in adults aged 65 years or older with isolated blunt thoracic trauma and more than three rib fractures. Participants will be enrolled in the Emergency Department of Ankara Etlik City Hospital. No experimental drug, device, or additional invasive procedure will be used. Routine clinical, laboratory, anthropometric, imaging, and follow-up data will be recorded. The study plans to include 294 participants. The primary outcome is a composite short-term poor clinical outcome, including in-hospital mortality, intensive care unit admission, invasive or non-invasive mechanical ventilation, pneumonia, atelectasis, tube thoracostomy, or hospital stay of 7 days or longer. The prognostic performances of GNRI and PNI will be compared. Secondary outcomes include the individual components of the composite outcome, new pneumothorax or hemothorax, hospital and intensive care unit length of stay, 30-day emergency department revisit, and 30-day mortality.
Detailed description
Older adults with multiple rib fractures may have an increased risk of respiratory complications, intensive care admission, prolonged hospitalization, and mortality after thoracic trauma. Nutritional impairment may contribute to this risk through reduced respiratory muscle strength and impaired immune response. The Geriatric Nutritional Risk Index (GNRI) and Prognostic Nutritional Index (PNI) are practical nutritional assessment tools calculated from routinely available clinical and laboratory data.
This is a prospective, single-center, observational cohort study conducted in the Emergency Department of Ankara Etlik City Hospital. The study will include adults aged 65 years or older who present with isolated blunt thoracic trauma and more than three radiologically confirmed rib fractures. Patients will be evaluated during routine clinical care, and no additional treatment, medication, device, or invasive procedure will be administered for research purposes.
GNRI will be calculated using serum albumin, current body weight, and ideal body weight. PNI will be calculated using serum albumin and the total lymphocyte count. Height, weight, albumin, lymphocyte count, injury characteristics, associated thoracic findings, treatment requirements, hospital course, and clinical outcomes will be recorded prospectively.
The primary analysis will assess the association of GNRI and PNI with the composite short-term poor clinical outcome. The prognostic performances of the two indices will be evaluated using receiver operating characteristic curve analysis, area under the curve comparisons, and optimal cut-off values. Multivariable logistic regression analysis will be used to identify factors independently associated with the primary outcome. Hospital outcomes will be obtained from clinical records. Thirty-day emergency department revisit and mortality data will be obtained from available health records or, when necessary, by telephone follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort of Older Adults With Multiple Rib Fractures | – | –Adults aged 65 years or older presenting to the emergency department with isolated blunt thoracic trauma and more than three radiologically confirmed rib fractures. Participants will be followed prospectively using routinely collected clinical, laboratory, anthropometric, imaging, treatment, and follow-up data. GNRI and PNI will be calculated and their associations with short-term clinical outcomes will be evaluated. No intervention is assigned; participants receive routine clinical care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population will consist of adults aged 65 years or older presenting to the Emergency Department of Ankara Etlik City Hospital with isolated blunt thoracic trauma and more than three radiologically confirmed rib fractures. Eligible participants will be prospectively enrolled and followed during the index hospitalization and for 30 days after enrollment.
Key inclusion criteria (6 listed)
- Age 65 years or older.
- Presentation to the emergency department with blunt thoracic trauma.
- More than three rib fractures confirmed by thoracic computed tomography or another appropriate radiologic method.
- Isolated thoracic trauma without major extra-thoracic injury.
- Serum albumin level, total lymphocyte count, height, and weight available within the first 24 hours after presentation.
Key exclusion criteria (8 listed)
- Penetrating thoracic trauma.
- Single rib fracture.
- Intubation at presentation.
- Polytrauma or major extra-thoracic injury.
- Known advanced liver failure, nephrotic syndrome, end-stage renal disease, or hematologic disease that may substantially affect albumin or lymphocyte levels.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite In-Hospital Adverse Outcome in Older Adults With Multiple Rib Fractures
Time frame: From enrollment through discharge from the index hospitalization, or up to 30 days after enrollment, whichever occurs first.
Occurrence within the index hospitalization or up to 30 days after enrollment of any of the following: in-hospital mortality; intensive care unit admission; invasive or non-invasive mechanical ventilation; pneumonia; atelectasis; chest tube placement due to pneumothorax or hemothorax; or total hospital length of stay of 7 days or longer.
11 secondary outcomes
Intensive Care Unit Admission
Time frame: From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.
Invasive or Non-invasive Mechanical Ventilation
Time frame: From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.
Pneumonia
Time frame: From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.
Atelectasis
Time frame: From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.
Tube Thoracostomy
Time frame: From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.
New-onset Pneumothorax
Time frame: From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.
New-onset Hemothorax
Time frame: From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.
Hospital Length of Stay
Time frame: From hospital admission until discharge or in-hospital death, whichever occurs first, assessed up to 30 days after hospital admission.
30-Day Emergency Department Revisit
Time frame: From discharge from the index hospitalization through 30 days after discharge.
30-Day Post-Discharge Mortality
Time frame: From discharge from the index hospitalization through 30 days after discharge.
In-Hospital Mortality
Time frame: From enrollment through 30 days after enrollment.
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 17 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. The dataset contains sensitive clinical information, and access will be restricted to the study investigators in accordance with the approved ethics protocol and participant confidentiality requirements. Only aggregate results will be reported.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Rib Fractures and Isolated Blunt Thoracic Trauma, run by Ankara Etlik City Hospital 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 17 Sep 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?
Contact Tuğba Sanalp Menekşe, MD (+90 551 414 64 22, tugba.sanalp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite In-Hospital Adverse Outcome in Older Adults With Multiple Rib Fractures (time frame: From enrollment through discharge from the index hospitalization, or up to 30 days after enrollment, whichever occurs first.). 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 17 Sep 2026.