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

Not Applicable

Completed

• Conditions: Inpatient Facililty Diagnoses
• Interventions: Device: Hillrom; Other: Control

• Registration Number: NCT04648579
• Lead Sponsor: Hospital do Coracao

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-23
• Study First Submitted QC: 2020-11-23
• Study First Posted: 2020-12-01
• Study Start: 2021-04-22
• Primary Completion: 2021-09-30
• Status Verified: 2022-02
• Study Completion: 2022-12-30
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

Inclusion Criteria

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

Exclusion Criteria

• Individuals who need blood pressure measurement in lower members.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hillrom	Hillrom	The intervention involves an automated vital signs document system consisting of a mobile medical device for measuring vital signs (CSM / Hillrom) that collects and analyzes data acquired at the bedside to be sent to a remote data processing point (Digital Control Station), using Hillrom Connecta software.
Control	Control	Hospital usual care.

Primary Outcome Measures

Name	Time	Method
RRT	24 hours	Number of rapid response team triggers activated in a timely manner.

Trial Locations

Locations (1)

Hospital do Coracao; 🇧🇷 São Paulo, Sao Paulo, Brazil