Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594562
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
Free Fluid Detection with Telementored EFAST
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Telementored EFAST in Patients Post-Liver Surgery a Study of Diagnostic Accuracy for Detection of Free Fluid
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
This feasibility study will evaluate the accuracy of telementored eFAST Extended Focused Assessment with Sonography in Trauma in detecting abdominal free fluid in patients who have recently undergone liver surgery The primary goal is to determine how well the remote-guided ultrasound can identify fluid accumulation compared to conventional ultrasound performed by a radiologist Participants in this study will be examined with ultrasound supported in real-time by a remote expert to assess its accuracy and other relevant performance metrics
Detailed Description:
The study is designed as a prospective diagnostic trial and involves 40 patients at Oslo University Hospital
Participants will receive an ultrasound examination shortly after surgery where a nurse is guided in real-time by a remote expert via teleultrasound The primary objective is to assess the agreement between the telementored eFAST examination and a conventional ultrasound performed by an on-site radiologist In addition to diagnostic accuracy the study will evaluate various performance metrics including the duration of the telementored versus conventional examinations network reliability and cognitive workload using the NASA Task Load Index
The study will also explore the learning curve associated with telementored eFAST by monitoring the improvement in examination efficiency over time These metrics will help determine the feasibility of using telementored ultrasound as a reliable diagnostic tool in postoperative care potentially reducing the need for more resource-intensive imaging modalities and improving patient outcomes through timely decision-making
Participants will receive an ultrasound examination shortly after surgery where a nurse is guided in real-time by a remote expert via teleultrasound The primary objective is to assess the agreement between the telementored eFAST examination and a conventional ultrasound performed by an on-site radiologist In addition to diagnostic accuracy the study will evaluate various performance metrics including the duration of the telementored versus conventional examinations network reliability and cognitive workload using the NASA Task Load Index
The study will also explore the learning curve associated with telementored eFAST by monitoring the improvement in examination efficiency over time These metrics will help determine the feasibility of using telementored ultrasound as a reliable diagnostic tool in postoperative care potentially reducing the need for more resource-intensive imaging modalities and improving patient outcomes through timely decision-making
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