DesaturationNCT00654693
NTX Wireless Patient Monitoring System
An observational study of Desaturation and Bradycardia, run by Vanderbilt University at 1 site in United States.
Trial summary
Determine the accuracy of the NTX wireless monitoring system alerts Evaluate patient compliance with wearing device Determine false alarm rates 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
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jun 2009
- 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: Participants will be recruited in the Vanderbilt University Medical Center pre-operative clinic or in the Round Wing, after the effects of anesthesia have worn off. Before performing any trial-related procedures, written Informed Consent and HIPAA authorization will be obtained.
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 Pilot Study to Evaluate the Performance of Nihon Kohden's NTX Wireless Patient Monitoring System
- Determine the accuracy of the NTX wireless monitoring system alerts
- Evaluate patient compliance with wearing device
- Determine false alarm rates
Read the detailed description
Approximately 150 patients will have wireless monitors attached to their arm. They will have their vital signs filtered through software that generates alerts and records data. The alert engine will produce pager and application based pop-up alerts which will be sent to the research nurse. Low and high limit alarms will be set according to the published guidelines (Hillman, K. et. Al., Resuscitation 48(2): 105-10, 2001) and adjusted at will by the response team.
During this portion of the study, the following research related procedures will be performed:
- begin continuous vital signs monitoring (BP - 1x per hour, 3 lead ECG -continuous, HR - continuous, SpO2 - continuous)
- PI or Co-PI will review each alert that's generated. The clinical significance will be determined and recorded in the study database
- Record patient's signs and symptoms daily
- Assess concomitant
- Assess AE's, SAEs
- Conditions
- Desaturation, Bradycardia, Tachycardia, Hypertension, Hypotension
- Being tested
- Rapid Response Team
- Keywords
- NTX, Nihon Kohden, mobile monitoring, monitoring, nihon, kohden, monitoring device, remote monitoring, wireless
- 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 TeamOther
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 |
|---|---|---|
| monitored | patients hospitalized for longer than 24 hours and are located on the 4th, 5th, and 6th floors of the Vanderbilt University Medical Center Round Wing Receives: Other: Rapid Response Team |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of patient compliance with wearing device
Measured: 24 hour minimum post op
Secondary outcomes (2)
Determine accuracy of the NTX wireless monitoring system
Measured: duration of patient involvement
Determine false alarm rates
Measured: duration of patient involvement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2009
- Study completionJun 2009
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.
- 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Berry, Vanderbilt University
- Investigators
- James M Berry, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654693
- Sponsor's protocol ID
- 080021
- Status last verified
- Sep 2012
- First submitted
- 3 Apr 2008
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Performance of Nihon Kohden's NTX Wireless Patient Monitoring System
- ClinicalTrials.gov ID
- NCT00654693
- Acronym / sponsor ID
- 080021
- Conditions
- Desaturation, Bradycardia, Tachycardia, Hypertension, Hypotension
- Keywords
- NTX, Nihon Kohden, mobile monitoring, monitoring, nihon, kohden, monitoring device, remote monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 9 Apr 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.
- Determine the accuracy of the NTX wireless monitoring system alerts
- Evaluate patient compliance with wearing device
- Determine false alarm rates
Detailed description
Approximately 150 patients will have wireless monitors attached to their arm. They will have their vital signs filtered through software that generates alerts and records data. The alert engine will produce pager and application based pop-up alerts which will be sent to the research nurse. Low and high limit alarms will be set according to the published guidelines (Hillman, K. et. Al., Resuscitation 48(2): 105-10, 2001) and adjusted at will by the response team.
During this portion of the study, the following research related procedures will be performed:
- begin continuous vital signs monitoring (BP - 1x per hour, 3 lead ECG -continuous, HR - continuous, SpO2 - continuous)
- PI or Co-PI will review each alert that's generated. The clinical significance will be determined and recorded in the study database
- Record patient's signs and symptoms daily
- Assess concomitant
- Assess AE's, SAEs
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| monitored | – | Other: Rapid Response Teampatients hospitalized for longer than 24 hours and are located on the 4th, 5th, and 6th floors of the Vanderbilt University Medical Center Round Wing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited in the Vanderbilt University Medical Center pre-operative clinic or in the Round Wing, after the effects of anesthesia have worn off. Before performing any trial-related procedures, written Informed Consent and HIPAA authorization will be obtained.
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 TeamAlso: - 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 | monitored |
Primary outcome
Evaluation of patient compliance with wearing device
Time frame: 24 hour minimum post op
2 secondary outcomes
Determine accuracy of the NTX wireless monitoring system
Time frame: duration of patient involvement
Determine false alarm rates
Time frame: duration of patient involvement
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 7 Sep 2012.
- 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.
James M Berry, M.D. 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 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 7 Sep 2012. 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?
Evaluation of patient compliance with wearing device (time frame: 24 hour minimum post op). 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 7 Sep 2012.