GNRI and PNI for Predicting Short-Term Outcomes in Older Adults With Multiple Rib Fractures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorAnkara Etlik City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Penetrating thoracic trauma.
Single rib fracture.
Intubation at presentation.
Polytrauma or major extra-thoracic injury.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
294 Participants
are grouped into 1 trial groupGroup A: Prospective Cohort of Older Adults With Multiple Rib Fractures
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment through discharge from the index hospitalization, or up to 30 days after enrollment, whichever occurs first.Secondary outcomes
1
Intensive Care Unit Admission
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.2
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.
Time frame
From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.3
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.
Time frame
From enrollment through discharge from the index hospitalization or up to 30 days after enrollment, whichever occurs first.4
Atelectasis
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.Sponsors and contacts
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Source ClinicalTrials.gov