Optimized Novel Wireless Assessment of Respiratory and Circulatory Dirstress - Alarm Validation (ONWARD - AV)
Validation of the Accuracy and Relevance of Continuous Vital Sign Monitoring Using an AI-algorithm in Hospitalized Patients
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
The ONWARD study evaluates user experiences from continuous vital sign monitoring alarms sent to the clinical staff in case of deviating vital signs at the general hospital ward. User experiences are evaluated though a 5-point likert questionnaire.
The study will focus on adult, hospitalized patients who are monitored at the general hospital ward with continuous, real-time vital sign monitoring combined with the WARD-CSS (WARD clinical support system) that relays alerts to the clinical staff in case of significant deviations. The evaluation focus on the user perceived relevance and usefulness of the alerts generated by the system which includes a proprietary novel alerts logic. Specifically, investigators aim to assess how users evaluate the clinical relevance of triggered change-based alerts and the helpfulness of the accompanying alert descriptions.
During monitoring, the app will be used according to the intended use and additionally two questions will be prompted if alerts are sent.
Patients monitored will have an expected length of stay at the hospital, which supports at least one day of continuous monitoring. Readings from the WARD-CSS is not blinded for treating staff to get feedback on the use of the application. This study will include up to 100 patients.
An alerting feedback questionnaire will be constructed as simple feedback buttons/sliders, prompted after an alert is 'accepted' in the app. The feedback buttons will only be prompted for a representative proportion of the alerts. This will be done at random based on the alert frequencies determined in the retrospective analysis. This way, a close to equal amount of feedback responses will be prompted and obtained for different alert types with different occurrences. The feedback will be linked to the alert in the app, such that feedback can be submitted at any point in time, thus not disturbing the nurse while medical intervention is provided.
The feedback will be constructed with the following two interactions for the clinical staff.
- Alert relevance in relation to deterioration of the patient (5-point Likert scale).
- Relevance of the description following alerts in relation to the helpfulness in the patient assessment/care (5-point Likert scale)
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Eske K Aasvang, DMSci
- Numer telefonu: +4526232076
- E-mail: Eske.Kvanner.Aasvang.01@regionh.dk
Kopia zapasowa kontaktu do badania
- Nazwa: Aslak B Johansen, M.D.
- Numer telefonu: +4522952551
- E-mail: aslak.broby.johansen@regionh.dk
Lokalizacje studiów
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Copenhagen, Dania, 2100
- Rigshospitalet
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Copenhagen, Dania, 2400
- Bispebjerg Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion criteria:
Patients can be included if they meet all the following criteria:
- Age ≥ 18 years
- Patients assessed by the clinical staff as having an acute condition with risk for clinical deterioration.
- Expected admission for more than 24 hours to a general ward.
Exclusion criteria:
Patients are excluded if they meet any of the following criteria:
- Having implanted electronic devices (such as pacemaker or Implantable Cardioverter Defibrillator (ICD) device).
- Known pregnancy or breastfeeding
- Inability to give informed consent.
- The participant expected not to cooperate with study procedures.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Adult, hospitalized patients who are monitored for vital signs in the general wards
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The intervention involves continuous, real-time vital sign monitoring using sensors to measure vital signs combined with WARD-CSS and novel algorithms designed to detect clinically relevant deviations in the vital signs.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Relevance of alerts
Ramy czasowe: Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.
|
The staff evaluated relevance of alerts triggered during continuous vital signs monitoring Evaluated by 5-point Likert scale: 1. Not relevant 2 Slightly relevant 3 Moderately relevant 4 Relevant 5 Highly Relevant |
Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Relevance of the description
Ramy czasowe: Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.
|
Relevance of the description following alerts in relation to the helpfulness in the patient assessment/care Evaluated by 5-point Likert scale:
4 Agree 5 Strongly Agree |
Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Alert rate
Ramy czasowe: Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.
|
Total alert rate, including false alert rate, of the WARD-CSS.
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Start of monitoring after enrollment with informed consent. An expected minimum of 24 hours of monitoring up to 7 days after start of monitoring.
|
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Postoperative complications
Ramy czasowe: 30 days
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Postoperative complications, defined by internationally agreed criteria
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30 days
|
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Heart rate (measured in beats per minute (BPM))
Ramy czasowe: 7 days
|
Collected continuously
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7 days
|
|
SpO2 (blood oxygen saturation, measured in percentage)
Ramy czasowe: 7 days
|
Collected continuously
|
7 days
|
|
Blood pressure (measured in mmHg)
Ramy czasowe: 7 days
|
Collected continuously
|
7 days
|
|
Respiration Rate (measured in BrPM)
Ramy czasowe: 7 days
|
Collected continuously
|
7 days
|
|
Pulse (measured in BPM)
Ramy czasowe: 7 days
|
Peripheral pulse - Collected continuously
|
7 days
|
|
Temperature (measured in degrees Celcius)
Ramy czasowe: 7 days
|
Collected continuously
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7 days
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2502107 (MREC)
- 2025071987 (Inny identyfikator: DMA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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