Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04827342
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2021-03-26
Brief Title:
Feasibility and Functionality Test of Adas DDSS Prototype
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Feasibility and Functionality Test of Adas DDSS Prototype Exploring the Potential and Performance When Diagnosing Complex Cases of Dyspnea at the Emergency Department and Ward of Interna Medicine of the University Hospital Basel
Status:
COMPLETED
Status Verified Date:
2021-03
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:
Ada4dyspnoe
Brief Summary:
This study is to explore with a feasibility and functionality test the potential of the Ada DDSS prototype with cases of dyspnea patients using the data collected at the Emergency Department ED and the ward of Internal medicine of the University Hospital Basel
Detailed Description:
This is an observational ie non-interventional prospective feasibility study which assesses through observation the potential functionality and diagnostic performance of the Ada DDSS prototype in evaluating patients presenting with dyspnea as primary predominant complaint to the ED
Once the consent form is signed the Investigator documents patients data medical history symptoms and findings with the Ada DDSS prototype During the entire patient journey through the hospital presentation at the ED through to admission in the ward of Internal Medicine relevant information are collected and documented in the Ada DDSS prototype simultaneously to standard documentation by the medical staff
Examination and treatment are carried out by the attending physician without being influenced or affected by the entry of data in the Ada DDSS prototype
There is no interventionchange made to the usual care and therefore neither an intervention patient group nor a control patient group The usual care that each patient receives is the control comparison point for the performance of the Ada DDSS The diagnoses proposed by the tool at different times after triage in the emergency centre when transferred to the ward and when discharged from the hospital are then compared with those of the attending physician
Once the consent form is signed the Investigator documents patients data medical history symptoms and findings with the Ada DDSS prototype During the entire patient journey through the hospital presentation at the ED through to admission in the ward of Internal Medicine relevant information are collected and documented in the Ada DDSS prototype simultaneously to standard documentation by the medical staff
Examination and treatment are carried out by the attending physician without being influenced or affected by the entry of data in the Ada DDSS prototype
There is no interventionchange made to the usual care and therefore neither an intervention patient group nor a control patient group The usual care that each patient receives is the control comparison point for the performance of the Ada DDSS The diagnoses proposed by the tool at different times after triage in the emergency centre when transferred to the ward and when discharged from the hospital are then compared with those of the attending physician
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