TelemetryNCT03039738
Surveillance Monitoring as an Alternative to Telemetry
A study testing Vital Sync IM & VPMP (Surveillance Monitoring) and Telemetry Monitoring in people with Telemetry and Patient Monitoring, run by Medtronic - MITG at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the impact of surveillance monitoring versus telemetry monitoring on clinical, healthcare economics, resource utilization, and qualitative outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Telemetry, Patient Monitoring
- What is being tested?
- Vital Sync IM & VPMP (Surveillance Monitoring) and Telemetry Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2017to 4 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Signed and dated informed consent by subject
- Male or female 18 years of age or older
- Expected hospitalized admission on the general care floor or medical surgical unit for at least one overnight stay and/or > 12 hours
- Scheduled for telemetry monitoring
- Diagnosis indicates American Heart Association (AHA) telemetry Class III or none and therefore not indicated for telemetry monitoring
- For surveillance monitoring group subjects, treating provider who scheduled subject for telemetry agrees to alternative monitoring plan of surveillance monitoring
- Willingness to have study devices attached and hair shaved at sensor location as needed during study participation
- Willingness to participate in all aspects of the study
Who cannot join
- Implanted pacemaker or atrial defibrillator
- Allergy or sensitivity to ECG leads or adhesives that are similar to ECG leads
- Current AHA Class I or II indication/prescription for telemetry monitoring
- Prescription for other continuous condition monitoring such as capnography or pulse oximetry
- Ongoing opioid therapy by patient-controlled analgesia (PCA), by epidural or intrathecal infusions or by intravenous analgesia, per Investigator discretion
- Ventilated or intubated patients at the time of enrollment
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- Female subject is pregnant, lactating, trying to get pregnant, or has a positive pregnancy test for women with childbearing potential
- Condition that, in the opinion of the investigator, may prevent completion of the study or protocol requirements
- Subject is considered as being morbidly obese (defined as BMI >50.0)
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in Saint Louis
St Louis, Missouri, 63130
About this study
Official title: A Prospective Evaluation of Surveillance Monitoring as an Alternative to Telemetry in Patients Scheduled for Telemetry Without American Heart Association (AHA) Indication
The purpose of the study is to evaluate the impact of surveillance monitoring versus telemetry monitoring on clinical, healthcare economics, resource utilization, and qualitative outcomes.
Read the detailed description
This will be single-center, prospective, pilot, pre/post implementation study to collect post-market data on hospitalized subjects monitored via telemetry and surveillance monitoring
- Conditions
- Telemetry, Patient Monitoring
- Being tested
- Vital Sync IM & VPMP (Surveillance Monitoring), Telemetry Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vital Sync IM & VPMP (Surveillance Monitoring)Device
The Vital Sync™ Informatics Manager (IM) \& Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.
Telemetry MonitoringDevice
Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.
| Study group | Role | What they receive |
|---|---|---|
| Telemetry Monitoring Arm | Active comparator | The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols. Receives: Device: Telemetry Monitoring |
| Surveillance Monitoring Arm | Experimental | Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform. Receives: Device: Vital Sync IM & VPMP (Surveillance Monitoring) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Length of Stay (LOS) as Assessed by Review of Medical Records
LOS will be determined by comparing LOS Between the Surveillance Monitoring and Telemetry Monitoring Period Arms.
Measured: Baseline to end of hospital stay (or up to 30 day post enrollment)
Secondary outcomes (7)
Associated Health Care Costs (HCC) as Determined by Review of Billing Records
Health Care Costs will be determined by comparing HCC between the surveillance monitoring and telemetry monitoring arms
Measured: Baseline to end of hospital stay (or up to 30 days post enrollment)
Number of Participants With Hospital Unit Transfers (HUT) as Determined by Review of Medical Records
Hospital Unit Transfers (HUT) will be determined by comparing the number of hospital unit transfers between monitoring arms.
Measured: Baseline to end of hospital stay (or up to 30 days post enrollment)
Length of Stay (LOS) in the ICU as Determined by Review of Medical Records
Length of Stay in the ICU will be determined by comparing numbers between monitoring arms.
Measured: Baseline to end of hospital stay (or up to 30 days post enrollment)
Number of Participants With Clinical Interventions (CI) as Determined by Review of Medical Records
CI include Rapid Response Team calls and Code Blue Activations. The Number of Clinical Interventions will be determined by comparing numbers between monitoring arms.
Measured: Baseline to end of hospital stay (or up to 30 days post enrollment)
Time of Rapid Response Team Activation to Time of a Threshold Notification as Measured by the Surveillance Monitoring System Only
Time of Rapid Response Team (RRT) will be determined by comparing the number of RRT interventions between monitoring arms (only for surveillance monitoring arm)
Measured: Baseline to end of hospital stay (or up to 30 days post enrollment)
Clinical Team and Patient Satisfaction as Measured by Qualitative Questionnaires
Clinical Team and Patient Satisfaction will be determined by comparing the Qualitative Questionnaire response between monitoring arms.
Measured: Baseline to end of hospital stay (or up to 30 days post enrollment)
Clinicians Familiarity With AHA Guidelines and Telemetry Utilization as Measured by Qualitative Questionnaires
Number of clinicians "very familiar" and "somewhat familiar" with AHA guidelines was reported. The questionnaire was administered to all clinicians (e.g. ED physicians, nurses, critical care nurses, intensivists, and hospitalists) involved in the care of study participants at each hospital; it was not administered to study subjects.
Measured: Baseline to end of hospital stay (or up to 30 days post enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start3 Apr 2017
- Primary completion4 Jan 2018
- Study completion4 Jan 2018
Why it stopped: Medtronic shift in strategic direction for study device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TelemetryStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stacey House, MD, PhD, Principal investigator, Washington University in Saint Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039738
- Sponsor's protocol ID
- COVMOPO0561
- Status last verified
- Apr 2019
- First submitted
- 30 Jan 2017
- Last updated
- 13 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of Surveillance Monitoring as an Alternative to Telemetry in Patients Scheduled for Telemetry Without American Heart Association (AHA) Indication
- ClinicalTrials.gov ID
- NCT03039738
- Acronym / sponsor ID
- COVMOPO0561
- Conditions
- Telemetry, Patient Monitoring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Medtronic shift in strategic direction for study device
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 4 Jan 2018 (actual)
- Study completion
- 4 Jan 2018 (actual)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Posted 29 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the impact of surveillance monitoring versus telemetry monitoring on clinical, healthcare economics, resource utilization, and qualitative outcomes.
Detailed description
This will be single-center, prospective, pilot, pre/post implementation study to collect post-market data on hospitalized subjects monitored via telemetry and surveillance monitoring
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemetry Monitoring Arm | Active comparator | Device: Telemetry MonitoringThe telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols. |
| Surveillance Monitoring Arm | Experimental | Device: Vital Sync IM & VPMP (Surveillance Monitoring)Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed and dated informed consent by subject
- Male or female 18 years of age or older
- Expected hospitalized admission on the general care floor or medical surgical unit for at least one overnight stay and/or > 12 hours
- Scheduled for telemetry monitoring
- Diagnosis indicates American Heart Association (AHA) telemetry Class III or none and therefore not indicated for telemetry monitoring
Key exclusion criteria (9 listed)
- Implanted pacemaker or atrial defibrillator
- Allergy or sensitivity to ECG leads or adhesives that are similar to ECG leads
- Current AHA Class I or II indication/prescription for telemetry monitoring
- Prescription for other continuous condition monitoring such as capnography or pulse oximetry
- Ongoing opioid therapy by patient-controlled analgesia (PCA), by epidural or intrathecal infusions or by intravenous analgesia, per Investigator discretion
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 |
|---|---|---|
| Vital Sync IM & VPMP (Surveillance Monitoring)The Vital Sync™ Informatics Manager (IM) \& Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution. | Device | Surveillance Monitoring Arm |
| Telemetry MonitoringContinuous ECG monitoring for hospitalized patients at-risk for cardiac events. | Device | Telemetry Monitoring Arm |
Primary outcome
Hospital Length of Stay (LOS) as Assessed by Review of Medical Records
Time frame: Baseline to end of hospital stay (or up to 30 day post enrollment)
LOS will be determined by comparing LOS Between the Surveillance Monitoring and Telemetry Monitoring Period Arms.
7 secondary outcomes
Associated Health Care Costs (HCC) as Determined by Review of Billing Records
Time frame: Baseline to end of hospital stay (or up to 30 days post enrollment)
Number of Participants With Hospital Unit Transfers (HUT) as Determined by Review of Medical Records
Time frame: Baseline to end of hospital stay (or up to 30 days post enrollment)
Length of Stay (LOS) in the ICU as Determined by Review of Medical Records
Time frame: Baseline to end of hospital stay (or up to 30 days post enrollment)
Number of Participants With Clinical Interventions (CI) as Determined by Review of Medical Records
Time frame: Baseline to end of hospital stay (or up to 30 days post enrollment)
Time of Rapid Response Team Activation to Time of a Threshold Notification as Measured by the Surveillance Monitoring System Only
Time frame: Baseline to end of hospital stay (or up to 30 days post enrollment)
Clinical Team and Patient Satisfaction as Measured by Qualitative Questionnaires
Time frame: Baseline to end of hospital stay (or up to 30 days post enrollment)
Clinicians Familiarity With AHA Guidelines and Telemetry Utilization as Measured by Qualitative Questionnaires
Time frame: Baseline to end of hospital stay (or up to 30 days post enrollment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Stacey House, MD, PhD principal investigator
Washington University in Saint Louis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vital Sync IM & VPMP (Surveillance Monitoring) and Telemetry Monitoring in people with Telemetry and Patient Monitoring, run by Medtronic - MITG at 1 site in United States.
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 8 inclusion and 9 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: stopped early, as of the sponsor's last update on 13 May 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 29 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hospital Length of Stay (LOS) as Assessed by Review of Medical Records (time frame: Baseline to end of hospital stay (or up to 30 day post enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2019.