Inpatient Facililty DiagnosesNCT04648579
Automated Documentation of Vital Parameters Using Mobile Stations and Activation of the Rapid Response Team
A study testing Hillrom in people with Inpatient Facililty Diagnoses, run by Hospital do Coracao at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inpatient Facililty Diagnoses
- What is being tested?
- Hillrom
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Apr 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with activated RRT during the study recruitment period.
Who cannot join
- Individuals who need blood pressure measurement in lower members.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Hillrom, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HillromDevice
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.
ControlOther
Hospital usual care regarding vital signs collection and TRR activation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Hillrom |
| Control | Active comparator | Hospital usual care. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
RRT
Number of rapid response team triggers activated in a timely manner.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start22 Apr 2021
- Primary completion30 Sep 2021
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inpatient Facililty DiagnosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José César Ribeiro, RN, Principal investigator, Hospital do Coracao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648579
- Sponsor's protocol ID
- HILLROM
- Status last verified
- Feb 2022
- First submitted
- 23 Nov 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be available upon reasonable request including a short study protocol. Both sponsor and funders will evaluate all requests. Brazilian regulatory agencies approval will be also required.
Publications
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.
PubMed 36351064
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04648579
- Acronym / sponsor ID
- HILLROM
- Conditions
- Inpatient Facililty Diagnoses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 1 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hillrom | Experimental | Device: HillromThe 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 | Active comparator | Other: ControlHospital usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with activated RRT during the study recruitment period.
Key exclusion criteria (1 listed)
- Individuals who need blood pressure measurement in lower members.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HillromHillrom 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. | Device | Hillrom |
| ControlHospital usual care regarding vital signs collection and TRR activation. | Other | Control |
Primary outcome
RRT
Time frame: 24 hours
Number of rapid response team triggers activated in a timely manner.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Derived from this study: PubMed 36351064Ribeiro 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.
- Individual participant dataSharing planned: Yes. Anonymized data will be available upon reasonable request including a short study protocol. Both sponsor and funders will evaluate all requests. Brazilian regulatory agencies approval will be also required.
Related trials for Inpatient Facililty Diagnoses
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José César Ribeiro, RN principal investigator
Hospital do Coracao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hillrom in people with Inpatient Facililty Diagnoses, run by Hospital do Coracao at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RRT (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04648579, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.