An observational study in Accidental Falls, Aged and Syncope, sponsored by Kocaeli City Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Kocaeli City Hospital · Observational
Falls are one of the most common reasons older adults visit the emergency department. In many older patients, a fall that looks "mechanical" is actually caused by an underlying medical problem such as syncope, heart disease, dehydration or blood clots, and the history is often unreliable. This single-center prospective study will evaluate whether a structured whole-body point-of-care ultrasound (POCUS) examination performed at the bedside changes how emergency physicians manage patients aged 65 years and older who come to the emergency department after a ground-level fall. The main question is how often POCUS findings change the physician's working diagnosis, consultation requests, additional tests, procedures, or admission/discharge decisions. Patients will also be followed for one week for death and repeat emergency department visits.
This is a prospective, single-center cohort study conducted in the adult emergency department of Kocaeli City Hospital (Kocaeli, Türkiye) over 12 months. Consecutive patients aged 65 years or older presenting after a ground-level fall who give written informed consent (personally or through a legal representative) will be enrolled.
After the initial assessment by the treating emergency physician, demographic data, fall mechanism and history, Glasgow Coma Scale, vital signs, chronic diseases, Charlson Comorbidity Index, Clinical Frailty Scale (Rockwood) and medications (including fall-risk-increasing drugs and recent changes) are recorded. Before ultrasound, the treating physician records his/her working diagnosis and planned consultations, additional tests, minor/major procedures and disposition (admission/discharge/transfer).
A whole-body POCUS examination is then performed by trained emergency medicine residents who are blinded to the clinical information and the physician's plan, using a portable ultrasound device (Esaote MyLab Gamma) with curvilinear, linear and phased-array probes. The protocol includes: carotid artery ultrasound (plaque presence and total plaque area), inferior vena cava diameter and collapsibility, aortic root and abdominal aorta, FAST examination for free fluid, focused cardiac ultrasound (ejection fraction estimate, pericardial effusion, right ventricular strain, valvular pathology), lung ultrasound (pneumothorax; pleural effusion and pulmonary edema when indicated), 3-point compression ultrasound for deep vein thrombosis when there is leg swelling, and quadriceps muscle thickness.
The findings are reported to the treating physician, who makes all clinical decisions independently; the study does not request any additional tests or treatments. The physician then records whether the working diagnosis, consultation needs, additional test requests, need for procedures and disposition decision changed. One-week mortality and repeat emergency department visits are checked through the national e-Nabiz health record system or by telephone.
Sample size: Assuming a 5% baseline (p0) and an expected 13.8% (p1) rate of management change, with alpha = 0.05 and 80% power, the minimum sample size is 93; allowing for 10% loss, 105 patients will be enrolled.
Statistical analysis: Continuous variables will be presented as mean (SD) or median (IQR) according to distribution (Kolmogorov-Smirnov test) and categorical variables as number (%). Groups will be compared with the independent samples t-test or Mann-Whitney U test and the chi-square or Fisher's exact test. Variables associated with a change in management (p\<0.10 in univariable analysis) will be entered into multivariable logistic regression; results will be reported as odds ratios with 95% confidence intervals. A two-sided p\<0.05 will be considered significant.
232 studies on the registry are indexed under Syncope; 45 are open to participants now.
This study's planned enrollment of 105 is below the median of 235 across 95 observational studies indexed under Syncope.
Browse Syncope studies →Kocaeli City Hospital is the lead sponsor of 41 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients aged 65 years and older presenting to the adult emergency department of Kocaeli City Hospital (Kocaeli, Türkiye) after a ground-level fall.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients aged 65 years and older presenting to the adult emergency department after a ground-level fall, who undergo a structured whole-body point-of-care ultrasound examination in addition to standard emergency department care.
Diagnostic Test: Whole-body point-of-care ultrasound (POCUS)
Structured bedside ultrasound examination performed by trained emergency medicine residents who are blinded to clinical information: carotid arteries, inferior vena cava, aortic root and abdominal aorta, FAST, focused cardiac ultrasound, lung ultrasound, quadriceps muscle thickness and, when indicated, 3-point compression ultrasound for deep vein thrombosis. Findings are reported to the treating physician, who makes all clinical decisions.
Rate of Change in Emergency Department Management After Whole-Body POCUS
Proportion of patients in whom the treating physician reports at least one change after POCUS in: working diagnosis regarding the cause of the fall, consultation request, additional test request, need for a minor or major procedure, or disposition decision (admission/discharge/transfer), compared with the plan recorded before POCUS.
Time frame: During the emergency department stay (up to 24 hours)
Change in Working Diagnosis
Proportion of patients whose working diagnosis regarding the cause of the fall changed after POCUS.
Time frame: During the emergency department stay (up to 24 hours)
Change in Consultation Requests
Proportion of patients with a new or cancelled specialist consultation after POCUS.
Time frame: During the emergency department stay (up to 24 hours)
Change in Disposition Decision
Proportion of patients whose admission/discharge/transfer decision changed after POCUS.
Time frame: During the emergency department stay (up to 24 hours)
Need for Minor or Major Procedures
Proportion of patients in whom a new minor (e.g., arterial blood gas sampling, nasogastric or urinary catheter) or major (e.g., central venous catheter, tube thoracostomy, pericardiocentesis, surgery, procedural sedation) procedure was indicated after POCUS.
Time frame: During the emergency department stay (up to 24 hours)
Contribution of POCUS to Identifying the Cause of the Fall
Proportion of patients in whom POCUS identified a pathology considered by the treating physician to be related to the cause of the fall.
Time frame: During the emergency department stay (up to 24 hours)
One-Week Mortality
All-cause death within 7 days of the index emergency department visit, assessed via the national e-Nabiz health record system or telephone, and its association with POCUS findings.
Time frame: 7 days
Repeat Emergency Department Visits Within One Week
Return to the emergency department within 7 days of the index visit, assessed via the national e-Nabiz health record system or telephone, and its association with POCUS findings.
Time frame: 7 days
Plan to share: No — Individual participant data will not be shared publicly because of national personal data protection regulations (KVKK).
Started Oct 2026 (actual). Primary completion is estimated for Oct 2027, 12 months after the start.
Of 51 observational studies under Syncope, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 13. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Kocaeli City Hospital