Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376643
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-16
Brief Title:
Augmented Reality to Support Cardiopulmonary Resuscitation
Sponsor:
Johan Siebert MD
Organization:
Pediatric Clinical Research Platform
Study Overview
Official Title:
Evaluation of an Augmented Reality and Screen-based Decision Support System for Cardiopulmonary Arrest a Multicenter Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective multicenter randomized clinical trial in two tertiary pediatric emergency department It will assess amongst pediatric healthcare teams whether the use of augmented reality supportive devices improves adherence to American Heart Association AHA advanced life support guidelines and performance while reducing medication errors when compared to groups using the AHA pocket reference card control during standardized simulation-based pediatric in-hospital cardiac arrest IHCA scenarios Seventy participants will be randomized The primary endpoint is the time to first dose of epinephrine
Detailed Description:
Each year thousands of children experience cardiopulmonary arrests CA requiring immediate and accurate resuscitation for favorable outcomes However adherence to American Heart Association AHA advanced life support guidelines remains suboptimal hindered by cognitive and communication challenges in high-stress cardiopulmonary resuscitation CPR situations To address this problem will assess a novel augmented reality AR-assisted digital health solution designed to offer personalized real-time decision support for team leaders and medication nurses while concurrently optimizing team situational awareness and communication by projecting a dynamic care roadmap onto a large screen in the resuscitation room controlled via a mobile tablet app
The solution comprises three essential digitally interconnected elements 1 a mobile app that presents clinical algorithms alongside patient data guiding the resuscitation team through step-by-step procedures 2 a giant screen that displays real-time patient information and task progress for the entire resuscitation team and 3 augmented reality devices worn by team members providing role-specific guidance and decision support based on data collected by the app
In this trial we will assess amongst pediatric healthcare teams whether the use of the AR-assisted tool improves adherence to AHA resuscitation guidelines and performance while reducing medication errors when compared to groups using the AHA pocket reference card control in an open-label prospective multicenter cluster randomized 11 ratio clinical trial Seventy physicians and nurses in teams of five will have to manage simulated pediatric in-hospital cardiac arrest IHCA scenarios while using the AR-assisted tool or conventional AHA pocket reference cards
The primary outcome is the time in seconds to first dose of epinephrine Secondary outcomes are times to CPR initiation defibrillation drug delivery airway securing the rate of medication errors CPR pause frequency CPR quality excellent CPR percentage chest compression fraction peri-shock pause duration provider workload NASA-TLX survey and stress STAI user experience UEQ system usability SUS and technology acceptance UTAUT
The solution comprises three essential digitally interconnected elements 1 a mobile app that presents clinical algorithms alongside patient data guiding the resuscitation team through step-by-step procedures 2 a giant screen that displays real-time patient information and task progress for the entire resuscitation team and 3 augmented reality devices worn by team members providing role-specific guidance and decision support based on data collected by the app
In this trial we will assess amongst pediatric healthcare teams whether the use of the AR-assisted tool improves adherence to AHA resuscitation guidelines and performance while reducing medication errors when compared to groups using the AHA pocket reference card control in an open-label prospective multicenter cluster randomized 11 ratio clinical trial Seventy physicians and nurses in teams of five will have to manage simulated pediatric in-hospital cardiac arrest IHCA scenarios while using the AR-assisted tool or conventional AHA pocket reference cards
The primary outcome is the time in seconds to first dose of epinephrine Secondary outcomes are times to CPR initiation defibrillation drug delivery airway securing the rate of medication errors CPR pause frequency CPR quality excellent CPR percentage chest compression fraction peri-shock pause duration provider workload NASA-TLX survey and stress STAI user experience UEQ system usability SUS and technology acceptance UTAUT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None