Accidental FallsNCT07886164
Whole-Body Point-of-Care Ultrasound in Older Adults Presenting to the Emergency Department After a Fall
An observational study of Accidental Falls and Aged, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Accidental Falls, Aged, Syncope
- What is being tested?
- Whole-body point-of-care ultrasound (POCUS)
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Oct 2026to Dec 2027
- Phase
- Observational
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: Patients aged 65 years and older presenting to the adult emergency department of Kocaeli City Hospital (Kocaeli, Türkiye) after a ground-level fall.
Who may be able to join
- Age 65 years or older
- Presentation to the emergency department after a ground-level fall
- No condition preventing whole-body ultrasound (no amputation preventing quadriceps muscle measurement; no open wound or burn on the chest or abdomen preventing cardiac ultrasound or FAST; no neck lesion preventing carotid ultrasound)
- Written informed consent given by the patient or a legal representative
Who cannot join
- High-energy trauma mechanism (e.g., traffic accident, fall from height, crush injury)
- Hemodynamic instability requiring priority resuscitation
- Withdrawal of consent
- Loss to follow-up or missing outcome data
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
Kocaeli City Hospital, Department of Emergency Medicine
İzmit, Kocaeli, 41060
Melike Yılmaz, MD, +90 538 892 99 06, md.melikeyilmaz@gmail.com
About this study
Official title: The Effect of Whole-Body Point-of-Care Ultrasonography on Emergency Department Management of Patients Aged 65 Years and Older Presenting With a Ground-Level Fall
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.
Read the detailed description
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.
- Conditions
- Accidental Falls, Aged, Syncope
- Being tested
- Whole-body point-of-care ultrasound (POCUS)
- Keywords
- Point-of-Care Ultrasound, POCUS, Geriatric Emergency Medicine, Falls in the Elderly, Emergency Department, Carotid Plaque, Focused Cardiac Ultrasound, Frailty
- Medical subject headings
- Syncope, Emergencies, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-body point-of-care ultrasound (POCUS)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Older adults after a ground-level fall | 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. Receives: Diagnostic Test: Whole-body point-of-care ultrasound (POCUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the emergency department stay (up to 24 hours)
Secondary outcomes (7)
Change in Working Diagnosis
Proportion of patients whose working diagnosis regarding the cause of the fall changed after POCUS.
Measured: 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.
Measured: During the emergency department stay (up to 24 hours)
Change in Disposition Decision
Proportion of patients whose admission/discharge/transfer decision changed after POCUS.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start12 Oct 2026
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies 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
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Asım Enes Özbek, MD, Assoc. Prof., Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886164
- Sponsor's protocol ID
- 2026-192
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 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 publicly because of national personal data protection regulations (KVKK).
Publications
O' Brien H, Anne Kenny R. Syncope in the Elderly. Eur Cardiol. 2014 Jul;9(1):28-36. doi: 10.15420/ecr.2014.9.1.28.
PubMed 30310482Latham LP, Ackroyd-Stolarz S. Emergency department utilization by older adults: a descriptive study. Can Geriatr J. 2014 Dec 2;17(4):118-25. doi: 10.5770/cgj.17.108. eCollection 2014 Dec.
PubMed 25452824Ucar G, Aksay E, Bayram B, Guzelce MC, Ergun YK. The diagnostic efficiency of whole-body bedside ultrasonography protocol for syncope patients in the emergency department. Am J Emerg Med. 2023 May;67:17-23. doi: 10.1016/j.ajem.2023.01.043. Epub 2023 Feb 3.
PubMed 36774906