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临床试验/NCT06646133
NCT06646133撤回不适用

Machine Learning and 3D Image-Based Modeling for Real-Time Body Weight and Body Composition Estimation During Emergency Medical Care: Study 2 - Measure the Accuracy and Speed of Weight Estimations Using a 3D Camera System During Simulated Medical Emergencies

Florida Atlantic University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2027年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
60
试验地点
1
主要终点
Weight estimation accuracy

研究概览

简要总结

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.

详细描述

The performance of the 3D camera system needs to be evaluated in conditions in which it will be used in a clinical setting, but without the risk to patients. It also needs to be compared against other, standard, methods of weight estimation. In addition the downstream accuracy of drug doses, with the correct use of alternative dose scalars (such as ideal body weight or lean body weight) in patients with obesity needs to be evaluated.

In this prospective crossover simulation study, resident and attending emergency physician volunteers will conduct simulated emergency care on simulated patient volunteers. The physicians will be randomised to start with either 3D camera systems, or standard care systems. After completing the scenario they will perform a new simulation scenario on a different patient using standard methods of weight estimation (crossover). At the end of the data collection session, each physician will have performed four scenarios (two standard methods, two 3D camera methods). Each simulated patient will similarly have participated in two standard method scenarios and two 3D camera scenarios. Each simulated patient and each physician will only have a single encounter.

In this way the accuracy of weight estimation and drug dosing can be compared between the 3D camera system and standard methods. In addition, inter-rater reliability can be determined and compared between resident and attending physicians.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Weight estimation accuracy

时间窗: During the simulation (intervention) procedure

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.

Weight estimation time

时间窗: During the simulation (intervention) procedure

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

Drug dose accuracy

时间窗: During the simulation (intervention) procedure

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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