Role of Wireless Monitoring in Internal Medicine Unit for Ongoing Assessment of Acute Instable Patients (LiMS)
|ClinicalTrials.gov Identifier: NCT03050034|
Recruitment Status : Unknown
Verified February 2017 by Filomena Pietrantonio, Azienda Socio Sanitaria Territoriale del Garda.
Recruitment status was: Not yet recruiting
First Posted : February 10, 2017
Last Update Posted : February 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Wireless Vital Signs Monitoring System Acutely Ill Complex and Poly-pathological Patients Internal Medicine Unit Mission||Device: WIN @ Hospital system Other: Traditional monitoring||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||296 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Pilot perspective controlled randomized open-label single-center study to evaluate the management of critically ill patients hospitalized comparing vital signs wireless monitoring versus conventional monitoring in the first 72 h of hospitalization extendable to 5 days if the MEWS after 72 h is even greater than or equal to 3 and/or the NEWS is greater than or equal to 5.|
|Masking:||None (Open Label)|
|Official Title:||Role of Wireless Monitoring in Internal Medicine Unit for Ongoing Assessment of Acute Instable Patients: Impact on Outcomes, Length of Stay and Costs.|
|Estimated Study Start Date :||February 27, 2017|
|Estimated Primary Completion Date :||October 27, 2017|
|Estimated Study Completion Date :||February 27, 2018|
Experimental: Vital signs wireless monitoring system
All patients with MEWS (Modified Early Warning Score) greater than or equal to 3 and/or NEWS (National Early Warning Score) greater than or equal to 5, at admission, regardless of the reason for hospitalization and all patients with glycemic decompensation and/or severe fluid and electrolyte imbalance, regardless of MEWS/ NEWS, undergone to continuous monitoring with wireless monitoring system WIN @ Hospital.
Device: WIN @ Hospital system
WIN @ Hospital system is a wearable and wireless system (Medical Class IIA) that allows continuous and real-time vital signs monitoring, automatically calculating the NEWS score with a personalized alert system for the patient. It does not require the continuous presence of the nurse in front of the control room, but is working with alert on portable devices (ipad).
Active Comparator: Control arm
All patients with MEWS (Modified Early Warning Score) greater than or equal to 3 and/or NEWS (National Early Warning Score) greater than or equal to 5, at admission, regardless of the reason for admission and all patients with glycemic decompensation and/or severe fluid and electrolyte imbalance, regardless of MEWS NEWS undergone to traditional monitoring performed at regular intervals by the nursing staff.
Other: Traditional monitoring
Vital signs control performed by nurse staff each 6 hours or more, according to medical advice.
- Major complications reduction in subjects monitored with continuous wireless system [ Time Frame: 12 months ]Reduction of major complications of critically ill patients from 15% to 5%.n subjects monitored with continuous wireless system
- Hospitalization costs reduction [ Time Frame: 12 months ]1 day reduction of patient's average length of hospital stay
- Reduced nurse's time in monitoring vital parameters [ Time Frame: 12 months ]Reduction of minutes of nursing commitment in monitoring vital parameters/ 24h
- Patients' stratification according to level of intensity of care [ Time Frame: 12 months ]Stratification of the patients hospitalized in Internal Medicine according to the level of intensity of care (using the MEWS score and NEWS - National Early Warning Scorei) and definition of end stage patients
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050034
|Contact: Filomena Pietrantonio, MDfirstname.lastname@example.org|
|Contact: Anna Bussi, MDemail@example.com|
|Principal Investigator:||Filomena Pietrantonio, MD||ASST-Garda|