Ankara Etlik City Hospital, Department of Emergency Medicine
Ankara, 06170, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07823712
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.
Interested in participating?
Request Info65 year and older
All sexes
Observational
Ankara, 06170, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.
Admission to any intensive care unit during the index hospitalization after enrollment.
Time frame: From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.
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.
Time frame: From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.
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.
Time frame: From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.
Newly developed atelectasis detected by chest radiography or chest computed tomography during the index hospitalization.
Time frame: From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.
Insertion of a chest tube for the treatment of pneumothorax or hemothorax during the index hospitalization.
Time frame: From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.
Newly developed pneumothorax diagnosed during the index hospitalization after enrollment.
Time frame: From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.
Newly developed hemothorax diagnosed during the index hospitalization after enrollment.
Time frame: From hospital admission until discharge or in-hospital death, whichever occurs first, assessed up to 30 days after hospital admission.
Total number of days from hospital admission to discharge or in-hospital death during the index hospitalization.
Time frame: From discharge from the index hospitalization through 30 days after discharge.
Any repeat visit to the emergency department within 30 days after discharge from the index hospitalization.
Time frame: From discharge from the index hospitalization through 30 days after discharge.
Death from any cause within 30 days after discharge from the index hospitalization.
Time frame: From enrollment through 30 days after enrollment.
Death from any cause during the index hospitalization.
Contact information is provided by the study sponsor or research team.
Ankara Etlik City Hospital
Other Gov
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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