Automated Documentation of Vital Parameters Using Mobile Stations and Activation of the Rapid Response Team

Inpatient Facililty Diagnoses Clinical Trial

Official title:

Automated Documentation of Vital Parameters in Wards Using Mobile Stations - Effect on the Appropriate Activation of the Rapid Response Team: a Cluster Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04648579
• Other study ID #: HILLROM
• Status: Completed
• Phase: N/A
• Start date: April 22, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2022
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The documentation of vital signs is traditionally performed manually when the patient is not admitted in intensive care units, which can lead to documentary errors, long time for data acquisition and, consequently, impairment in the early identification of possible clinical deterioration. In-bed technology solutions are available to automate the collection of vital data and transfer information to a medical record or central electronic monitoring and its role in the health value chain needs further investigation. The investigators propose to evaluate the impact of the Connex Spot Monitor solution Welch Allyn (CSM / Hillrom) in conjunction with the Hillrom Connecta solution in a real world situation, conducting a cluster randomized trilal in wards of a tertiary hospital. In addition, this study aims to estimate the clinical effectiveness of a technological solution that performs an analysis of vital signs and automatically activates the rapid response team (RRT) when the pre-defined criteria are met, comparing it with the traditional manual method. The primary outcome is the number of times that the RRT fires in a timely manner.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: December 30, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients with activated RRT during the study recruitment period.

Exclusion Criteria:

• Individuals who need blood pressure measurement in lower members.

Related Conditions & MeSH terms

• Disease
• Inpatient Facililty Diagnoses

Intervention

Device:
• Hillrom
Hillrom Connecta solution will record vital signs in an automated way, without the need for human intervention, and activate TRR activation when at least one criteria is met. The frequency of monitoring vital signs will be defined based on the MEWS score.

Other:
• Control
Hospital usual care regarding vital signs collection and TRR activation.

Locations

Country	Name	City	State
Brazil	Hospital do Coracao	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital do Coracao

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RRT	Number of rapid response team triggers activated in a timely manner.	24 hours