Machine Learning and 3D Image-Based Modeling for Real-Time Body Weight and Body Composition Estimation During Emergency Medical Care. Study 3

December 15, 2025 updated by: Florida Atlantic University

Machine Learning and 3D Image-Based Modeling for Real-Time Body Weight and Body Composition Estimation During Emergency Medical Care. Study 3 - Measure the Accuracy of Weight Estimations by The 3D Camera System in Acutely Ill or Injured Emergency Department Patients and Compare This Accuracy Against That of Standard Care.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Drug dosing errors can have a catastrophic effect in acutely ill patients such as stroke patients needing thrombolytic therapy or patients requiring urgent sedation. In an acutely ill patient, inaccurate weight estimates are a significant cause of dosing errors, and weight estimates that deviate by >10% from actual weight could make treatment itself life threatening. Inaccurate weight estimates lead to inaccurate drug doses, which can result in potentially fatal treatment failure (from subtherapeutic doses) or potentially fatal adverse events (from supratherapeutic doses). Nearly 75% of treatment failures in obese patients may be related to errors in weight estimation. When clinical care is time-sensitive, it may be impossible to obtain a measured weight in >50% of patients. In these circumstances, a rapid, accurate method for estimating weight is critical. One recent innovation is the use of a low-cost 3D camera system to estimate weight. The 3D camera device (e.g., Intel RealSense D415) is used to obtain a point cloud map of the patient's body, from which a weight estimate can be estimated based on algorithms derived using convoluted neural network analysis. Initial studies have been extremely promising in terms of the accuracy achievable by this system in estimating Total Body Weight (TBW).

The primary aim of this study is to measure the accuracy of weight estimations by the 3D camera system in acutely ill or injured ED patients and compare this accuracy against that of standard care. The researchers will compare the performance and downstream effects of weight estimation using the 3D camera system against standard care in a randomized controlled trial of acutely ill or injured adults presenting to the ED.

The key hypothesis is that the 3D camera system will provide real-time estimates of TBW, IBW and LBW in an emergency setting and will exceed the accuracy of existing methods of weight estimation.

Supporting non-clinical trial studies will establish the accuracy of the 3D camera system in laboratory conditions, and in simulated medical emergencies. However, its performance, and its impact on downstream drug dosing accuracy, needs to be established during emergency care in a real clinical setting. This study will provide an essential perspective about the accuracy and functioning of the 3D camera system as well as real-world weight estimation during emergency care. It will also describe the ability to measure weight using in-bed scales and to obtain weight estimations from patients themselves and family members in ED patients. The secondary objective, to determine the accuracy of drug doses in each arm of the study, will provide critical information on the need for alternative weight scalars in obese and morbidly obese patients presenting to the ED. The study will establish the need for standards and policies to guide dose scaling in obese patients in the ED. Information on the actual usage of drugs that should be scaled to TBW and those that should be scaled to LBW will provide useful real-world insight into the magnitude of the problem in the threat to patient safety by using a "one size fits all" approach to drug dose calculations for all patients, irrespective of weight status.

Acutely ill patients presenting to the ED of a large regional hospital, and who require weight-based drug therapy, will be enrolled in the study. They will be randomised to either receive a weight estimation using a 3D camera system (which will provide estimates of TBW, IBW and LBW), or to receive standard care. All other interventions and medical care will be standard care.

These patients will be followed for the first 72 hours of their hospital stay. The accuracy of the weight estimates will be compared between the groups, as will the drug dose accuracy, and any adverse events related to drug therapy.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients who are unable to provide consent.
  • Patients whose medical treatment could be negatively impacted by participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D camera weight estimation
TBW, 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
Other: Weight estimation using 3D camera
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.
Other Names:
  • Weight estimation using computer vision
No Intervention: Control arm (standard care)
TBW, 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight estimation accuracy
Time Frame: Immediately on enrolment
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
Time Frame: Immediately on enrolment
Measurement of time taken to obtain weight estimate
Immediately on enrolment
Drug dosing accuracy
Time Frame: First 72 hours after enrolment
Determination of accuracy of drug doses against reference standard
First 72 hours after enrolment
Correct dosing scalar used
Time Frame: First 72 hours after enrolment
Determination of appropriateness of dosing scalar used for each drug
First 72 hours after enrolment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of in-bed scales
Time Frame: First 72 hours after enrolment
Determination of accuracy of weight estimate from in-bed or in-stretcher scales against reference standard
First 72 hours after enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida Atlantic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2029

Primary Completion (Estimated)

November 30, 2029

Study Completion (Estimated)

July 1, 2030

Study Registration Dates

First Submitted

October 15, 2024

First Submitted That Met QC Criteria

October 15, 2024

First Posted (Actual)

October 17, 2024

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1791994(3)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Within 6 months of the completion of the study.

IPD Sharing Access Criteria

Upon request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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