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

NCT04648579 | Completed

• 1 other identifier: HILLROM
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

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.

Conditions

Inpatient Facililty Diagnoses

Outcome Measures

Primary Outcomes (1)

• RRT

  Number of rapid response team triggers activated in a timely manner.

  24 hours

Study Arms (2)

Hillrom

EXPERIMENTAL

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.

Device: Hillrom

Control

ACTIVE COMPARATOR

Hospital usual care.

Other: Control

Interventions

Hillrom 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.

Hillrom

Control OTHER

Hospital usual care regarding vital signs collection and TRR activation.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- Individuals who need blood pressure measurement in lower members.

Sponsors & Collaborators

• Hospital do Coracao: lead

Study Sites (1)

Hospital do Coracao

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 36351064 DERIVED

Study Officials

• José César Ribeiro, RN

  Hospital do Coracao

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 1, 2020
• Study Start: April 22, 2021
• Primary Completion: September 30, 2021
• Study Completion: December 30, 2022
• Last Updated: March 1, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After main paper publication.

Locations

BR (1)