Cardiac EventPREVENTNCT00750958
PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard
A study testing NetGuard Automated Clinician Alert System in people with Cardiac Event, run by Datascope Patient Monitoring at 2 sites in United States.
Trial summary
The purpose of this study is to determine the incidence of clinically significant rhythm and rate changes in ED patients who are not placed on conventional telemetry, and to test the user-friendliness of a automated clinician alter device in hectic and noisy setting of a busy emergency room. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Event
- What is being tested?
- NetGuard Automated Clinician Alert System
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2008to Jul 2008
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 18 yes
- Agree to participate in study
- Telemetry not indicated
- Telemetry not available
- Willingness to complete a questionnaire-
Who cannot join
- Refusal to participate
- Know sensitivity to adhesive
- Language/communication barriers
- Perceived high risk for lack of study compliance
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dr Charles Pollack
Philadelphia, Pennsylvania, 19107
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
About this study
The purpose of this study is to determine the incidence of clinically significant rhythm and rate changes in ED patients who are not placed on conventional telemetry, and to test the user-friendliness of a automated clinician alter device in hectic and noisy setting of a busy emergency room.
- Conditions
- Cardiac Event
- Being tested
- NetGuard Automated Clinician Alert System
- Keywords
- cardiac rhythm changes
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NetGuard Automated Clinician Alert SystemProcedure or surgery
Also called NetGurard Automated Clinican Alert Systemm
Monitoring System for in-hospital patients who are typically unmonitored. Identifies and alarms for cardiac rhythm changes.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | ED patients that are not monitored with conventional therapy. Receives: Procedure: NetGuard Automated Clinician Alert System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinically significant rhythm and rate changes in ED patients.
Measured: Patient ED stay
Secondary outcomes (1)
Measure of user-friendliness of the device.
Measured: Patient ED stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac EventStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Datascope Patient Monitoring
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Charles Pollack, MD, Principal investigator, Pennslvania Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750958
- Sponsor's protocol ID
- 807119
- Acronym
- PREVENT
- Status last verified
- Sep 2008
- First submitted
- 10 Sep 2008
- Last updated
- 11 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard
- ClinicalTrials.gov ID
- NCT00750958
- Acronym / sponsor ID
- PREVENT / 807119
- Conditions
- Cardiac Event
- Keywords
- cardiac rhythm changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Datascope Patient MonitoringIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 11 Sep 2008 (estimated)
- 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 purpose of this study is to determine the incidence of clinically significant rhythm and rate changes in ED patients who are not placed on conventional telemetry, and to test the user-friendliness of a automated clinician alter device in hectic and noisy setting of a busy emergency room.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | Procedure: NetGuard Automated Clinician Alert SystemED patients that are not monitored with conventional therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 18 yes
- Agree to participate in study
- Telemetry not indicated
- Telemetry not available
- Willingness to complete a questionnaire-
Key exclusion criteria (4 listed)
- Refusal to participate
- Know sensitivity to adhesive
- Language/communication barriers
- Perceived high risk for lack of study compliance
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 |
|---|---|---|
| NetGuard Automated Clinician Alert SystemAlso: NetGurard Automated Clinican Alert SystemmMonitoring System for in-hospital patients who are typically unmonitored. Identifies and alarms for cardiac rhythm changes. | Procedure or surgery | 1 |
Primary outcome
Incidence of clinically significant rhythm and rate changes in ED patients.
Time frame: Patient ED stay
1 secondary outcome
Measure of user-friendliness of the device.
Time frame: Patient ED stay
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 11 Sep 2008.
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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.
Charles Pollack, MD principal investigator
Pennslvania Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NetGuard Automated Clinician Alert System in people with Cardiac Event, run by Datascope Patient Monitoring at 2 sites 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 5 inclusion and 4 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 11 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Incidence of clinically significant rhythm and rate changes in ED patients. (time frame: Patient ED stay). 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 11 Sep 2008.