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
- 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: 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07886164
- Acronym / sponsor ID
- 2026-192
- Conditions
- Accidental Falls, Aged, Syncope
- Keywords
- Point-of-Care Ultrasound, POCUS, Geriatric Emergency Medicine, Falls in the Elderly, Emergency Department, Carotid Plaque, Focused Cardiac Ultrasound, Frailty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 12 Oct 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Oct 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older adults after a ground-level fall | – | Diagnostic Test: Whole-body point-of-care ultrasound (POCUS)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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Older adults after a ground-level fall |
Primary outcome
Rate of Change in Emergency Department Management After Whole-Body POCUS
Time frame: During the emergency department stay (up to 24 hours)
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.
7 secondary outcomes
Change in Working Diagnosis
Time frame: During the emergency department stay (up to 24 hours)
Change in Consultation Requests
Time frame: During the emergency department stay (up to 24 hours)
Change in Disposition Decision
Time frame: During the emergency department stay (up to 24 hours)
Need for Minor or Major Procedures
Time frame: During the emergency department stay (up to 24 hours)
Contribution of POCUS to Identifying the Cause of the Fall
Time frame: During the emergency department stay (up to 24 hours)
One-Week Mortality
Time frame: 7 days
Repeat Emergency Department Visits Within One Week
Time frame: 7 days
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 21 Oct 2026.
- Background: PubMed 30310482O' 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.
- Background: PubMed 25452824Latham 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.
- Background: PubMed 36774906Ucar 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly because of national personal data protection regulations (KVKK).
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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.
Asım Enes Özbek, MD, Assoc. Prof. principal investigator
Kocaeli City Hospital
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 Accidental Falls and Aged, run by Kocaeli 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 4 inclusion and 4 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 21 Oct 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 Melike Yılmaz, MD (+90 538 892 99 06, md.melikeyilmaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Change in Emergency Department Management After Whole-Body POCUS (time frame: During the emergency department stay (up to 24 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07886164, which also lists 3 linked publications.
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 21 Oct 2026.