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Continuous Monitoring on the General Ward

24 aprile 2017 aggiornato da: Radboud University Medical Center

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

Tipo di studio

Interventistico

Iscrizione (Effettivo)

90

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 85 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

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

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

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
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

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Harry van Goor, MD, PhD, FRCS, Radboud University Medical Center

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 aprile 2015

Completamento primario (Effettivo)

1 agosto 2016

Completamento dello studio (Effettivo)

1 settembre 2016

Date di iscrizione allo studio

Primo inviato

25 luglio 2016

Primo inviato che soddisfa i criteri di controllo qualità

13 ottobre 2016

Primo Inserito (Stima)

14 ottobre 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 aprile 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 aprile 2017

Ultimo verificato

1 luglio 2016

Maggiori informazioni

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 .

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