- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Žádný zásah: Control group
Patients with regular measurements by nurses only (Modified Early Warning Score (MEWS))
|
|
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Experimentální: 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
|
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Expectations & experiences of patients
Časové okno: 2-3 days after informed consent
|
Interviews of 15-20 minutes with patients after 2-3 days wearing a device or control group
|
2-3 days after informed consent
|
|
Expectations & experiences of care givers
Časové okno: 1 year
|
Interviews with nurses of 15-20 minutes at the end of the study.
Estimated amount of 6 nurses
|
1 year
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
MEWS scores based on continuous data and data measured by nurses
Časové okno: 3 times a day, up to three days.
|
3 times a day, up to three days.
|
|
|
Amount of alarms by HealthPatch or ViSi Mobile
Časové okno: 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)
Časové okno: 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
Časové okno: during 2-3 days when the patient wears a device
|
during 2-3 days when the patient wears a device
|
|
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Admission to ICU (yes/no)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 1 year
|
1 year
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Gender
Časové okno: On day 1 when patients participates in the study
|
Extraction from EHR
|
On day 1 when patients participates in the study
|
|
Age
Časové okno: On day 1 when patients participates in the study
|
Extraction from EHR
|
On day 1 when patients participates in the study
|
|
Diagnosis
Časové okno: On day 1 when patients participates in the study
|
Extraction from EHR
|
On day 1 when patients participates in the study
|
|
Performed surgical procedure
Časové okno: On day 1 when patients participates in the study
|
Extraction from EHR
|
On day 1 when patients participates in the study
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Harry van Goor, MD, PhD, FRCS, Radboud University Medical Center
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Nemoci trávicího systému
- Novotvary podle histologického typu
- Novotvary
- Novotvary podle místa
- Adenokarcinom
- Karcinom
- Novotvary, žlázové a epiteliální
- Onemocnění endokrinního systému
- Gastrointestinální novotvary
- Novotvary trávicího systému
- Gastrointestinální onemocnění
- Novotvary endokrinních žláz
- Onemocnění tlustého střeva
- Střevní nemoci
- Střevní novotvary
- Rektální onemocnění
- Onemocnění slinivky břišní
- Novotvary, duktální, lobulární a medulární
- Novotvary pankreatu
- Karcinom, duktální
- Kolorektální novotvary
- Karcinom, pankreatický duktální
Další identifikační čísla studie
- HEEL-2015-03
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