Machine Learning and 3D Image-based Modeling for Body Weight Estimation.

NCT06281938 | Not Yet Recruiting

• 1 other identifier: 1617209
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this randomized controlled clinical trial is to \[learn about, test, compare etc.\] 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.

Conditions

No Specific Conditions; Weight, Body; Drug Dose; Weight-Estimation

Keywords

weight estimation; drug dosing; 3D camera; total body weight; lean body weight; ideal body weight

Outcome Measures

Primary Outcomes (4)

• Weight estimation accuracy

  Determination of accuracy against reference standard

  Immediate

• Time to obtain weight estimate

  Determination of time taken to obtain weight estimate

  Immediate

• Drug dosing accuracy

  Determination of accuracy against reference standard

  First 72 hours

• Correct dosing scalar used

  Determination of accuracy against reference standard

  First 72 hours

Secondary Outcomes (1)

• Accuracy of in-bed scales

  Immediate

Study Arms (2)

3D camera weight estimation

EXPERIMENTAL

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

Standard care weight estimation

PLACEBO COMPARATOR

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

Other: Standard care weight estimation

Interventions

Weight estimation using 3D camera OTHER

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.

3D camera weight estimation

Standard care weight estimation OTHER

Standard care (unspecified) will be used to determine weight-based dosing and other management.

Standard care weight estimation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Florida Atlantic University: lead

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mike Wells, MD, PhD

  Research Professor

  STUDY DIRECTOR

Central Study Contacts

Richard Shih, MD

CONTACT

561 297 3000; rshih@health.fau.edu

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

Model Details: Intervention cohort and control cohort will be used

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 6, 2025

Record last verified: 2025-06

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.