Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646133
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Machine Learning and 3D Image-Based Modeling for Real-Time Body Weight and Body Composition Estimation During Emergency Medical Care Study 2
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None