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Completed

NCT Number: NCT04827342

Feasibility and Functionality Test of Ada's DDSS Prototype

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

data collection in the Ada DDSS prototype

Other

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.

Primary outcomes

  1. Feasibility of the Ada DDSS prototype

    Time frame: during hospital stay (presentation at the ED through to admission in the ward of Internal Medicine, in the average 1 week)

    Feasibility of the Ada DDSS prototype simultaneously to standard documentation by the medical staff.

  2. Subjectively perceived benefit from using the Ada DDSS prototype

    Time frame: during hospital stay (presentation at the ED through to admission in the ward of Internal Medicine, in the average 1 week)

    Subjectively perceived benefit from using the Ada DDSS prototype (during patient journey in the hospital) assessed by a physician.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Ada Health GmbH

Registry information

Official study 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

Acronym: Ada4dyspnoe

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 1, 2021
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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