- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04827342
Feasibility and Functionality Test of Ada's DDSS Prototype (Ada4dyspnoe)
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Basel, Schweiz, 4031
- University Hospital Basel
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Feasibility of the Ada DDSS prototype
Tidsramme: 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.
|
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
Tidsramme: 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.
|
during hospital stay (presentation at the ED through to admission in the ward of Internal Medicine, in the average 1 week)
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jens Eckstein, Prof. Dr. med., University Hospital, Basel, Switzerland
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2020-00095; me19Eckstein3
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .