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

NCT ID: NCT04648579

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-22

Study Completion Date

2022-12-30

Brief Summary

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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

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Conditions

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Inpatient Facililty Diagnoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Hillrom

Intervention Type DEVICE

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.

Control

Hospital usual care.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Hospital usual care regarding vital signs collection and TRR activation.

Interventions

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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.

Intervention Type DEVICE

Control

Hospital usual care regarding vital signs collection and TRR activation.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- All patients with activated RRT during the study recruitment period.

Exclusion Criteria

\- Individuals who need blood pressure measurement in lower members.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital do Coracao

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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José César Ribeiro, RN

Role: PRINCIPAL_INVESTIGATOR

Hospital do Coracao

Locations

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Hospital do Coracao

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Ribeiro JC, Sgorbissa C, Silva KA, Braz MLD, Horak ACP, Nicola ML, Gurgel RM, Tokunaga SM, Negrelli KL, Murizine GS, Medrado Junior F, Coli RCP, Cavalcanti AB, Marcadenti A. Automated documentation of vital parameters in wards using portable stations - Effect on proper triggering of the rapid response team: a study protocol of a cluster randomized clinical trial. Rev Bras Ter Intensiva. 2022 Nov 4;34(3):319-326. doi: 10.5935/0103-507X.20220101-pt. eCollection 2022.

Reference Type DERIVED
PMID: 36351064 (View on PubMed)

Other Identifiers

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HILLROM

Identifier Type: -

Identifier Source: org_study_id

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