Falls, Tomography of the Head, Cervical Spine, Chest, Abdomen, and PelvisNCT05409001
Falls From Sitting to Standing
An observational study of Falls, Tomography of the Head, Cervical Spine, Chest, Abdomen, and Pelvis, run by Northwell Health at 1 site in United States.
Trial summary
Background: When evaluating trauma patients, many centers perform computed tomography of the head, cervical spine, chest, abdomen, and pelvis, the so-called "pan-scan." Here, we evaluate the utility of pan-scan in geriatric patients who sustained ground-level falls. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Falls, Tomography of the Head, Cervical Spine, Chest, Abdomen, and Pelvis
- What is being tested?
- tomography pan scan
- How many people
- 751 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2020to 9 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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: A retrospective chart review was conducted using the trauma registry at a large, urban Level 1 trauma center. This registry was queried for consecutive elderly patients (age >65 years) who presented with fall from sitting or standing from 01/01/2019-12/31/2019. This trauma registry includes all patients of which the trauma surgery team was notified as part of the insinuation's trauma notification protocol. It also includes patients who were ultimately admitted to the hospital with ICD 10 codes consistent with traumatic injuries, regardless of trauma team activation. Patients discharged from the Emergency Department with a traumatic injury may have limited data in the registry.
Who may be able to join
- age >65
- presented with fall from sitting or standing from 01/01/2019-12/31/2019
Who cannot join
- age <65 years,
- falls from height,
- GCS less than 14,
- patients who did not undergo the complete pan-scan.
Trial locations and contacts
1 site in 1 country.
About this study
Background: When evaluating trauma patients, many centers perform computed tomography of the head, cervical spine, chest, abdomen, and pelvis, the so-called "pan-scan." Here, we evaluate the utility of pan-scan in geriatric patients who sustained ground-level falls.
Study Design: We performed a retrospective review of consecutive patients from the trauma registry of a large, urban Level 1 trauma center. Inclusion criteria were registration during the 2019 calendar year, age ≥ 65, mechanism of fall from either sitting or standing, and performance of "pan-scan" at time of assessment. Patient demographics, physical exam findings, CT results, injuries, and patient disposition were recorded. The sensitivity, specificity, positive and negative predictive values of the physical exam for significant injuries were calculated.
- Being tested
- tomography pan scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tomography pan scanDiagnostic test
This is a retrospective chart review
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of physical exam compared to CT scan and identifying traumatic injuries
Sensitivity of physical exam compared to CT scan and identifying traumatic injuries. Sensitivity is a statistical measure which was calculated using our SAS software as described in methods. CT scan was used as the gold standard. Both physical exam and CAT scan were performed on initial presentation with a time frame on the order of minutes to hours.
Measured: 2 years
Prevalence of injury.
Traumatic injuries were determined by CT scan, tabulated, and broken down by body region as well as injury type. These data were collected at the time of CT scan on initial presentation. These data presented as whole numbers and percentages.
Measured: 2 years
Disposition from ED
Dispositions were determined by chart review, tabulated, and broken down by disposition location. These data collected at the time of admission
Measured: 2 years
Disposition from hospital.
Dispositions were determined by chart review, tabulated, and broken down by disposition location, including patient expiration in some cases. These data were collected at the time of discharge
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start6 Oct 2020
- Primary completion9 May 2022
- Study completion9 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Falls, Tomography of the Head, Cervical Spine, Chest, Abdomen, and PelvisStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 751 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409001
- Sponsor's protocol ID
- 20-0850 SIUHN
- Status last verified
- Jun 2022
- First submitted
- 23 May 2022
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: aggregate data will be published
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Falls From Sitting to Standing
- ClinicalTrials.gov ID
- NCT05409001
- Acronym / sponsor ID
- 20-0850 SIUHN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 751 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 7 Jun 2022 (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.
Background: When evaluating trauma patients, many centers perform computed tomography of the head, cervical spine, chest, abdomen, and pelvis, the so-called "pan-scan." Here, we evaluate the utility of pan-scan in geriatric patients who sustained ground-level falls.
Study Design: We performed a retrospective review of consecutive patients from the trauma registry of a large, urban Level 1 trauma center. Inclusion criteria were registration during the 2019 calendar year, age ≥ 65, mechanism of fall from either sitting or standing, and performance of "pan-scan" at time of assessment. Patient demographics, physical exam findings, CT results, injuries, and patient disposition were recorded. The sensitivity, specificity, positive and negative predictive values of the physical exam for significant injuries were calculated.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- A retrospective chart review was conducted using the trauma registry at a large, urban Level 1 trauma center. This registry was queried for consecutive elderly patients (age >65 years) who presented with fall from sitting or standing from 01/01/2019-12/31/2019. This trauma registry includes all patients of which the trauma surgery team was notified as part of the insinuation's trauma notification protocol. It also includes patients who were ultimately admitted to the hospital with ICD 10 codes consistent with traumatic injuries, regardless of trauma team activation. Patients discharged from the Emergency Department with a traumatic injury may have limited data in the registry.
Key inclusion criteria (2 listed)
- age >65
- presented with fall from sitting or standing from 01/01/2019-12/31/2019
Key exclusion criteria (4 listed)
- age <65 years,
- falls from height,
- GCS less than 14,
- patients who did not undergo the complete pan-scan.
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 |
|---|---|---|
| tomography pan scanThis is a retrospective chart review | Diagnostic test | – |
Primary outcome
Sensitivity of physical exam compared to CT scan and identifying traumatic injuries
Time frame: 2 years
Sensitivity of physical exam compared to CT scan and identifying traumatic injuries. Sensitivity is a statistical measure which was calculated using our SAS software as described in methods. CT scan was used as the gold standard. Both physical exam and CAT scan were performed on initial presentation with a time frame on the order of minutes to hours.
Prevalence of injury.
Time frame: 2 years
Traumatic injuries were determined by CT scan, tabulated, and broken down by body region as well as injury type. These data were collected at the time of CT scan on initial presentation. These data presented as whole numbers and percentages.
Disposition from ED
Time frame: 2 years
Dispositions were determined by chart review, tabulated, and broken down by disposition location. These data collected at the time of admission
Disposition from hospital.
Time frame: 2 years
Dispositions were determined by chart review, tabulated, and broken down by disposition location, including patient expiration in some cases. These data were collected at the time of discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Individual participant dataSharing planned: No. aggregate data will be published
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Falls, Tomography of the Head, Cervical Spine, Chest, Abdomen, and Pelvis, run by Northwell Health at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 7 Jun 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of physical exam compared to CT scan and identifying traumatic injuries (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2022; AzTrials last refreshed its copy on 30 Oct 2026.