DesaturationTATRCNCT00644644
Validation of the NTX Wireless Patient Monitoring System
An observational study of Desaturation and Bradycardia, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Reduction in time to detection of Clinically Significant events Reduction of time to Intervention during Clinically Significant events Reduction in the number of admissions to Intensive Care Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Desaturation, Bradycardia, Tachycardia
- What is being tested?
- Rapid Response Team (NTX wireless monitoring system)
- How many people
- 1,303 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jan 2010
- Phase
- Observational
- 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
Study population: Post-op orthopedic and GI patients who will be admitted for a minimum of 24 hours to the Round Wing area of Vanderbilt University Medical Center.
Who may be able to join
- Ability to give written informed consent
- Patients that are hospitalized for longer than 24 hours and are located on the 4th, 5th, or 6th floor of the Vanderbilt University Medical Center Round Wing
- Patients must be ≥18 years of age
Who cannot join
- ICU patients
- Female subjects who are pregnant
- Patients < 18 years of age
- Patients that have a contradiction for continuous Blood Pressure monitoring
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: A Validation of the NTX Wireless Patient Monitoring System in Combination With Novel Computer Interface to Generate Proactive Medical Responses to Patient Specific Events
- Reduction in time to detection of Clinically Significant events
- Reduction of time to Intervention during Clinically Significant events
- Reduction in the number of admissions to Intensive Care
Read the detailed description
1200 patients will have wireless monitors attached to their arm. They will be randomized to have their vital signs filtered through software that generates alerts, or software that does not generate alerts. Low and high limit alarms will be set according to published guidelines and adjusted at will by the response team. If appropriate the Vanderbilt University Medical Center Rapid Response team will be initiated per Institutional Policy
- Conditions
- Desaturation, Bradycardia, Tachycardia, Hypertension, Hypotension
- Being tested
- Rapid Response Team (NTX wireless monitoring system)
- Keywords
- NTX, Nihon Kohden, mobile monitoring
- Medical subject headings
- Bradycardia, Tachycardia, Hypertension, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Response Team (NTX wireless monitoring system)Other
Also called - attending nurse action per VUMC protocol
If the subject is experiencing a life threatening change in their vital signs, the Rapid Response Team will be initiated per VUMC protocol.
| Study group | Role | What they receive |
|---|---|---|
| 1 | monitored Receives: Other: Rapid Response Team (NTX wireless monitoring system) | |
| 2 | control |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if the NTX wireless monitoring system in combination with a novel computer interface will provide early detection of potentially life threatening changes in patient's vital signs
Measured: an interim analysis will be performed after 400 patients have been placed on the study, again after 800 have been places on the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DesaturationStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan France, Vanderbilt University
- Investigators
- Daniel J France, PhD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644644
- Sponsor's protocol ID
- 061241
- Acronym
- TATRC
- Status last verified
- Apr 2017
- First submitted
- 19 Mar 2008
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation of the NTX Wireless Patient Monitoring System in Combination With Novel Computer Interface to Generate Proactive Medical Responses to Patient Specific Events
- ClinicalTrials.gov ID
- NCT00644644
- Acronym / sponsor ID
- TATRC / 061241
- Conditions
- Desaturation, Bradycardia, Tachycardia, Hypertension, Hypotension
- Keywords
- NTX, Nihon Kohden, mobile monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,303 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 27 Mar 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.
- Reduction in time to detection of Clinically Significant events
- Reduction of time to Intervention during Clinically Significant events
- Reduction in the number of admissions to Intensive Care
Detailed description
1200 patients will have wireless monitors attached to their arm. They will be randomized to have their vital signs filtered through software that generates alerts, or software that does not generate alerts. Low and high limit alarms will be set according to published guidelines and adjusted at will by the response team. If appropriate the Vanderbilt University Medical Center Rapid Response team will be initiated per Institutional Policy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Rapid Response Team (NTX wireless monitoring system)monitored |
| 2 | – | –control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post-op orthopedic and GI patients who will be admitted for a minimum of 24 hours to the Round Wing area of Vanderbilt University Medical Center.
Key inclusion criteria (3 listed)
- Ability to give written informed consent
- Patients that are hospitalized for longer than 24 hours and are located on the 4th, 5th, or 6th floor of the Vanderbilt University Medical Center Round Wing
- Patients must be ≥18 years of age
Key exclusion criteria (4 listed)
- ICU patients
- Female subjects who are pregnant
- Patients < 18 years of age
- Patients that have a contradiction for continuous Blood Pressure monitoring
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 |
|---|---|---|
| Rapid Response Team (NTX wireless monitoring system)Also: - attending nurse action per VUMC protocolIf the subject is experiencing a life threatening change in their vital signs, the Rapid Response Team will be initiated per VUMC protocol. | Other | 1 |
Primary outcome
To determine if the NTX wireless monitoring system in combination with a novel computer interface will provide early detection of potentially life threatening changes in patient's vital signs
Time frame: an interim analysis will be performed after 400 patients have been placed on the study, again after 800 have been places on the study
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 Apr 2017.
- Vanderbilt University Medical Center Department of AnesthesiologyLink provided by the sponsor.
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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.
Daniel J France, PhD, MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Desaturation and Bradycardia, run by Vanderbilt University Medical Center 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 3 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 Apr 2017. 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?
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?
To determine if the NTX wireless monitoring system in combination with a novel computer interface will provide early detection of potentially life threatening changes in patient's vital signs (time frame: an interim analysis will be performed after 400 patients have been placed on the study, again after 800 have been places on the study). 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 Apr 2017.