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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT03050034
Date of registration: 08/02/2017
Prospective Registration: Yes
Primary sponsor: Azienda Socio Sanitaria Territoriale del Garda
Public title: Role of Wireless Monitoring in Internal Medicine Unit for Ongoing Assessment of Acute Instable Patients LiMS
Scientific title: Role of Wireless Monitoring in Internal Medicine Unit for Ongoing Assessment of Acute Instable Patients: Impact on Outcomes, Length of Stay and Costs.
Date of first enrolment: February 27, 2017
Target sample size: 296
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT03050034
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Italy
Contacts
Name:     Filomena Pietrantonio, MD
Address: 
Telephone: +393291710748
Email: filomena.pietrantonio@gmail.com
Affiliation: 
Name:     Filomena Pietrantonio, MD
Address: 
Telephone:
Email:
Affiliation:  ASST-Garda
Name:     Filomena Pietrantonio, MD
Address: 
Telephone: +393291710748
Email: filomena.pietrantonio@gmail.com
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

- all critical patients (with need for continuous monitoring and high technology) with
MEWS =3 and / or NEWS=5 at admission

- all patients with glycemic decompensation regardless of MEWS and NEWS.

- all critical patients severe fluid and electrolyte imbalance, regardless of MEWS and
NEWS.

Exclusion Criteria:

- MEWS <3 and or NEWS <5

- Lack of informed consent

- Inability to understand and want



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Acutely Ill Complex and Poly-pathological Patients
Internal Medicine Unit Mission
Wireless Vital Signs Monitoring System
Intervention(s)
Device: WIN @ Hospital system
Other: Traditional monitoring
Primary Outcome(s)
Major complications reduction in subjects monitored with continuous wireless system [Time Frame: 12 months]
Secondary Outcome(s)
Hospitalization costs reduction [Time Frame: 12 months]
Secondary ID(s)
LIMS2017
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
ASST-Garda: Internal Medicina Unit Manerbio Hospital (BS)
Modena and Reggio Emilia University Medical Statistic Department
Milano-Bicocca University Medical Statistic Department
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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