Study Stopped
No funding received.
Machine Learning and 3D Image-Based Modeling for Real-Time Body Weight and Body Composition Estimation During Emergency Medical Care. Study 3
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The goal of this randomized controlled clinical trial is to compare standard methods of weight estimation and drug dose calculations against weight estimates and dose calculations using a 3D camera weight estimation system in critically ill or injured cohorts of patients presenting to the Emergency Department. The main question\[s\] it aims to answer are: Are weight estimates from a 3D camera system more accurate than standard methods of weight estimation? Do patients who receive weight estimates with a 3D camera system have fewer drug dosing errors than patients receiving standard care? Participants will either receive a weight estimate using a 3D camera system, or standard methods of care. Researchers will compare the 3D camera group to those with standard care to see if the weight estimates are more accurate, to see if drug dosing is more accurate, and to compare the incidence of adverse events related to medications in each group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2029
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
CompletedFirst Posted
Study publicly available on registry
October 17, 2024
CompletedStudy Start
First participant enrolled
July 1, 2029
ExpectedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2029
Study Completion
Last participant's last visit for all outcomes
July 1, 2030
December 19, 2025
December 1, 2025
5 months
October 15, 2024
December 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Weight estimation accuracy
Determination of accuracy of estimates of total body weight, ideal body weight and lean body weight against reference standards
Immediately on enrolment
Time to obtain weight estimate
Measurement of time taken to obtain weight estimate
Immediately on enrolment
Drug dosing accuracy
Determination of accuracy of drug doses against reference standard
First 72 hours after enrolment
Correct dosing scalar used
Determination of appropriateness of dosing scalar used for each drug
First 72 hours after enrolment
Secondary Outcomes (1)
Accuracy of in-bed scales
First 72 hours after enrolment
Study Arms (2)
Control arm (standard care)
NO INTERVENTIONTBW, LBW and IBW will be estimated using standard care processes. All relevant medical care will be based on this weight for the first 72 hours
3D camera weight estimation
EXPERIMENTALTBW, LBW and IBW will be automatically estimated using the 3D camera system. All relevant medical care will be based on this weight for the first 72 hours
Interventions
Total body weight, ideal body weight and lean body weight estimates will be obtained using a 3D camera system. This weight will be used for calculation of weight-based drug doses and other weight-based interventions.
Eligibility Criteria
You may qualify if:
- Any patient presenting to the Emergency Department of the study site, who will require any form of weight-based intravenous drug therapy, and who will be admitted to the hospital.
You may not qualify if:
- Patients who are unable to provide consent.
- Patients whose medical treatment could be negatively impacted by participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (8)
Wells M, Goldstein LN, Cattermole G. Development and validation of a length- and habitus-based method of total body weight estimation in adults. Am J Emerg Med. 2022 Mar;53:44-53. doi: 10.1016/j.ajem.2021.12.053. Epub 2021 Dec 28.
PMID: 34974251BACKGROUNDWells 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: 36277563BACKGROUNDWells 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: 36123560BACKGROUNDWells 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: 36190388BACKGROUNDWells 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: 38056057BACKGROUNDSonar VG, Jan MT, Wells M, Pandya A, Engstrom G, Shih R, Furht B. Estimating Body Volume and Height Using 3D Data. arxiv. 2024 September; 2410.02800
BACKGROUNDJan MT, Kumar A, Wells M, Pandya A, Engstrom G, Shih R, Furht B. Comprehensive Survey of Body Weight Estimation: Techniques, Datasets and Applications. Multimedia Tools and Applications. 2024 October.
BACKGROUNDWells 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
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Investigators and outcomes assessors will be blinded to the arm. Coded data will be used for masking.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2024
First Posted
October 17, 2024
Study Start (Estimated)
July 1, 2029
Primary Completion (Estimated)
November 30, 2029
Study Completion (Estimated)
July 1, 2030
Last Updated
December 19, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
- Time Frame
- Within 6 months of the completion of the study.
- Access Criteria
- Upon request
Data generated during this project will be shared in multiple different forums. Data will be shared locally at Florida Atlantic University through presentations. Results will be made available to the broader scientific community through publications and presentations at national and international meetings. Protocols and/or method(s) developed during the proposed study will be made readily available for educational, research, and non-profit purposes, provided that a data-sharing agreement is signed. Any other important techniques developed from this work will be made available electronically for all non-business purposes described above. The intended date for such availability will be less than 6 months after the fulfillment of the Specific Aims of this proposal. In addition, a dataset containing non-identifiable point cloud data and images, along with ground truth weight data, will be stored in a repository that can be accessed through a data-sharing agreement.