NCT06646133

Brief Summary

The goal of this prospective crossover simulation study is to evaluate the accuracy and usability of a 3D camera weight estimation system during simulated emergency care in adult simulated patients, when used by emergency physicians. The main questions the study aims to answer are:

  • to evaluate the accuracy of 3D camera weight estimation during simulated emergency care, when compared with standard methods
  • to evaluate the usability of 3D camera weight estimation during emergency care, when compared with standard methods
  • to evaluate the inter-user reliability of 3D camera weight estimates Volunteers for simulated patients will be required to have anthropometric measurements, a DXA scan, and 3D camera weight estimates. Physician volunteers will need to participate in simulated emergency scenarios during which weight-based therapy must be administered. There will be no interventions.

Trial Health

50
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
8mo left

Started Jul 2027

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
2.7 years until next milestone

Study Start

First participant enrolled

July 1, 2027

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

October 15, 2024

Last Update Submit

December 15, 2025

Conditions

Keywords

weight estimationemergency drug dosing3D cameracomputer vision

Outcome Measures

Primary Outcomes (3)

  • Weight estimation accuracy

    The accuracy of estimations of total body weight, ideal body weight and lean body weight will be compared against ground truth data, and against other weight estimation systems.

    During the simulation (intervention) procedure

  • Weight estimation time

    The time taken to obtain a weight estimate will be compared against other weight estimation systems.

    During the simulation (intervention) procedure

  • Drug dose accuracy

    The accuracy of drug doses calculated using estimated weight will be compared against a ground truth value, and compared with other weight estimation systems.

    During the simulation (intervention) procedure

Study Arms (2)

Standard care weight estimation

Simulated patients in whom standard methods of weight estimation will be used.

Diagnostic Test: Standard methods of weight estimation

3D camera weight estimation

Simulated patients in whom 3D camera estimates of weight will be used.

Diagnostic Test: 3D camera weight estimate

Interventions

Standard methods of weight estimation will be used

Standard care weight estimation

Weight estimation using 3D camera system

3D camera weight estimation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Simulated patients will be enrolled from students, staff and faculty at the Boca Raton campus of Florida Atlantic university. Emergency physician participants will be enrolled from resident and attending emergency physicians in south Florida.

You may qualify if:

  • Any volunteer aged ≥18 years.

You may not qualify if:

  • Participants with a body weight exceeding the DXA machine capacity \>204kg (450lbs);
  • Pregnant participants; participants with medical conditions that could confound the study;
  • Participants with any metallic surgical implants;
  • Participants who have had an x-ray with contrast in the past week;
  • Participants who have taken calcium supplements in the 24 hours prior to the study.
  • \- Any willing emergency medicine resident or attending physician.
  • \- Any physical limitation to performing anthropometric measurements as part of simulation scenario.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Atlantic University

Boca Raton, Florida, 33143, United States

Location

Related Publications (6)

  • Wells M, Goldstein L. Appropriate Statistical Analysis and Data Reporting for Weight Estimation Studies. Pediatr Emerg Care. 2023 Jan 1;39(1):62-63. doi: 10.1097/PEC.0000000000002862. Epub 2022 Oct 1. No abstract available.

    PMID: 36190388BACKGROUND
  • Wells M, Goldstein LN, Cattermole G. Development and Validation of a Length- and Habitus-Based Method of Ideal and Lean Body Weight Estimation for Adults Requiring Urgent Weight-Based Medical Intervention. Eur J Drug Metab Pharmacokinet. 2022 Nov;47(6):841-853. doi: 10.1007/s13318-022-00796-3. Epub 2022 Sep 19.

    PMID: 36123560BACKGROUND
  • Wells M, Goldstein LN. Estimating Lean Body Weight in Adults With the PAWPER XL-MAC Tape Using Actual Measured Weight as an Input Variable. Cureus. 2022 Sep 17;14(9):e29278. doi: 10.7759/cureus.29278. eCollection 2022 Sep.

    PMID: 36277563BACKGROUND
  • Wells M, Henry B, Goldstein L. Weight Estimation for Drug Dose Calculations in the Prehospital Setting - A Systematic Review. Prehosp Disaster Med. 2023 Aug;38(4):471-484. doi: 10.1017/S1049023X23006027. Epub 2023 Jul 13.

    PMID: 37439214BACKGROUND
  • Wells M, Goldstein LN, Alter SM, Solano JJ, Engstrom G, Shih RD. The accuracy of total body weight estimation in adults - A systematic review and meta-analysis. Am J Emerg Med. 2024 Feb;76:123-135. doi: 10.1016/j.ajem.2023.11.037. Epub 2023 Nov 29.

    PMID: 38056057BACKGROUND
  • Wells M, Goldstein LN, Wells T, Ghazi N, Pandya A, Furht B, Engstrom G, Jan MT, Shih R. Total body weight estimation by 3D camera systems: Potential high-tech solutions for emergency medicine applications? A scoping review. J Am Coll Emerg Physicians Open. 2024 Oct 4;5(5):e13320. doi: 10.1002/emp2.13320. eCollection 2024 Oct.

    PMID: 39371964BACKGROUND

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2024

First Posted

October 17, 2024

Study Start (Estimated)

July 1, 2027

Primary Completion (Estimated)

February 28, 2028

Study Completion (Estimated)

February 28, 2028

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

The data will be made available on request.

Shared Documents
STUDY PROTOCOL
Time Frame
Within 6 months after the completion of the study.

Locations