Feasibility and Functionality Test of Ada's DDSS Prototype

Dyspnea Clinical Trial

— Ada4dyspnoe  

Official title:

Feasibility and Functionality Test of Ada's 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04827342
• Other study ID #: 2020-00095; me19Eckstein3
• Status: Completed
• Start date: May 6, 2020
• Est. completion date: August 7, 2020

Study information

• Verified date: March 2021
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is an observational i.e. 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 intervention/change 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 7, 2020
• Est. primary completion date: August 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Dyspnea as the main symptom when entering the emergency room
• Existence of written consent
• The patient is able to speak, understand and read German or English.

Exclusion Criteria:

• Inability or unwillingness to understand and comply with study procedures due to:
• Language problems
• Acute mental disorders
• Dementia
• Clinical instability (e..B. resuscitation treatment, non-invasive ventilation, etc.)

Related Conditions & MeSH terms

• Dyspnea

Intervention

Other:
• data collection in the Ada DDSS prototype
Entry of patients' data (medical history, symptoms and findings) in the Ada DDSS prototype. The tool then automatically creates a list of possible diagnostic suggestions based on the information, which are compared with the diagnoses of the attending physician.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Ada Health GmbH

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the Ada DDSS prototype	Feasibility of the Ada DDSS prototype simultaneously to standard documentation by the medical staff.	during hospital stay (presentation at the ED through to admission in the ward of Internal Medicine, in the average 1 week)
Primary	Subjectively perceived benefit from using the Ada DDSS prototype	Subjectively perceived benefit from using the Ada DDSS prototype (during patient journey in the hospital) assessed by a physician.	during hospital stay (presentation at the ED through to admission in the ward of Internal Medicine, in the average 1 week)