- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02933307
Continuous Monitoring on the General Ward
Continuous Monitoring of Vital Signs in Hospitalized Patients
Rationale: Monitoring patients' vital signs is done to detect clinical deterioration. For this, the MEWS, a scoring list comprising seven vital signs measured by nursing staff, is used. Although the MEWS provides relevant data on patients' health status, the interval measurements may not capture early deterioration of vital signs, especially during the night. As a result, unsafe situations may occur such as periods of low oxygen saturation and cardiac arrhythmias, which are known to complicate postoperative course. Besides, this way of measuring vital signs may be stressful for patients and disturbs patients' sleep. New technology such as ViSi Mobile and HealthPatch allows for remote continuous monitoring of vital signs using wearable devices transmitting relevant data to nurses and clinicians. With this, the investigators think that clinical deterioration may be detected in an early phase and reduce nurse work load and patient distress.
Objective: to investigate the feasibility of wearable devices on the general ward.
Study design: feasibility study.
Study population: adult patients hospitalized on the internal medicine ward and adult postoperative patients on the surgical ward.
Intervention: patients in the intervention groups will be randomized in one of the two groups. Patients in the group 1 will wear ViSi Mobile; patients in group 2 will wear the HealthPatch. Wearable devices will be worn for at least three days. Regular MEWS measurements take place at usual time points.
Main study parameters/endpoints: Evaluation with patient and care givers (primary outcome measure), MEWS calculations, time between alarm (continuous data) and next regular MEWS measurement (nurse), intervention by nurse after alarm, admission to ICU, complications, side effects of devices, STAI scores, and PCS scores will be documented.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will wear one device for at least three days. Devices can be uncomfortable by being heavy or the patches can start itching. More measurements by nurses can take place when indicated, for example after alarms. The participating patients will fill out the STAI on daily basis and the PCS on the last day of hospitalization. Both questionnaires will take a few minutes to complete. Patients could benefit from early detection of clinical deterioration and early corrective interventions or ICU admissions.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patient is 18 years or older on the day the informed consent will be signed.
- Patient is hospitalized on the surgical or internal medicine ward.
- MEWS measurements are required at least three times a day.
- Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations.
Exclusion Criteria:
- Frequency of MEWS measurements is less than three times a day.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Nessun intervento: Control group
Patients with regular measurements by nurses only (Modified Early Warning Score (MEWS))
|
|
Sperimentale: HealthPatch (Intervention)
Patients with HealthPatch and regular MEWS measurements
|
The HealthPatch (Vital Connect) is a wireless patch and continuously measures single-lead ECG, heart rate, respiratory rate, stress, skin temperature, body posture and steps
|
Sperimentale: ViSi Mobile (Intervention)
Patients with ViSi Mobile and regular MEWS measurements
|
ViSi Mobile (Sotera Wireless) is wireless device that is able to continuously measure all important vital parameters: ECG, heart rate, oxygen saturation, blood pressure, respiratory rate and skin temperature.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Expectations & experiences of patients
Lasso di tempo: 2-3 days after informed consent
|
Interviews of 15-20 minutes with patients after 2-3 days wearing a device or control group
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2-3 days after informed consent
|
Expectations & experiences of care givers
Lasso di tempo: 1 year
|
Interviews with nurses of 15-20 minutes at the end of the study.
Estimated amount of 6 nurses
|
1 year
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
MEWS scores based on continuous data and data measured by nurses
Lasso di tempo: 3 times a day, up to three days.
|
3 times a day, up to three days.
|
|
Amount of alarms by HealthPatch or ViSi Mobile
Lasso di tempo: during 2-3 days when the patient wears a device
|
during 2-3 days when the patient wears a device
|
|
Time between alarm (continuous data) and next regular MEWS measurement (nurse)
Lasso di tempo: during 2-3 days when the patient wears a device
|
during 2-3 days when the patient wears a device
|
|
Amount of extra MEWS measurements by nurses due to alarms
Lasso di tempo: during 2-3 days when the patient wears a device
|
during 2-3 days when the patient wears a device
|
|
Admission to ICU (yes/no)
Lasso di tempo: during 2-3 days when the patient participates in this study
|
during 2-3 days when the patient participates in this study
|
|
Duration of ICU hospitalization in days
Lasso di tempo: during 2-3 days when the patient participates in this study
|
during 2-3 days when the patient participates in this study
|
|
Complications caused by disease or surgical procedure
Lasso di tempo: during 2-3 days when the patient participates in this study
|
during 2-3 days when the patient participates in this study
|
|
Adverse events caused by devices
Lasso di tempo: during 2-3 days when the patient wears a device
|
E.g. Itch or redness
|
during 2-3 days when the patient wears a device
|
Technical failures of devices (artifacts: a period longer than 1 minute the device does not measure vital parameters)
Lasso di tempo: during 2-3 days when the patient wears a device
|
during 2-3 days when the patient wears a device
|
|
Outcomes of the State Trait Anxiety Inventory (STAI)
Lasso di tempo: Once a day during the 2-3 days the patient participantes in this study
|
Once a day during the 2-3 days the patient participantes in this study
|
|
Outcomes of the Pain Catastrophizing Scale (PCS)
Lasso di tempo: On day 2 or 3 when patients participates in the study
|
On day 2 or 3 when patients participates in the study
|
|
System usability Scale
Lasso di tempo: 1 year
|
1 year
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Gender
Lasso di tempo: On day 1 when patients participates in the study
|
Extraction from EHR
|
On day 1 when patients participates in the study
|
Age
Lasso di tempo: On day 1 when patients participates in the study
|
Extraction from EHR
|
On day 1 when patients participates in the study
|
Diagnosis
Lasso di tempo: On day 1 when patients participates in the study
|
Extraction from EHR
|
On day 1 when patients participates in the study
|
Performed surgical procedure
Lasso di tempo: On day 1 when patients participates in the study
|
Extraction from EHR
|
On day 1 when patients participates in the study
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Harry van Goor, MD, PhD, FRCS, Radboud University Medical Center
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Neoplasie per tipo istologico
- Neoplasie
- Neoplasie per sede
- Adenocarcinoma
- Carcinoma
- Neoplasie, ghiandolari ed epiteliali
- Malattie del sistema endocrino
- Neoplasie gastrointestinali
- Neoplasie dell'apparato digerente
- Malattie gastrointestinali
- Neoplasie delle ghiandole endocrine
- Malattie del colon
- Malattie intestinali
- Neoplasie intestinali
- Malattie del retto
- Malattie pancreatiche
- Neoplasie duttali, lobulari e midollari
- Neoplasie pancreatiche
- Carcinoma duttale
- Neoplasie colorettali
- Carcinoma, duttale pancreatico
Altri numeri di identificazione dello studio
- HEEL-2015-03
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su HealthPatch
-
Radboud University Medical CenterCompletatoFatica | Fattori di disturbo
-
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