Coronary Artery DiseaseNCT00598936
A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Cardiac Surgery Patients
An observational study of Coronary Artery Disease and Heart Valve Disease, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a new cerebral oxygenation monitoring device is comparatively similar to the current approved devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Heart Valve Disease
- What is being tested?
- CDI 1000 COM and INVOS 5100
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to May 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: Adult subjects ≥18 year-old of age admitted to the University Hospital setting scheduled for cardiac surgery or admitted for any cause to the Intensive Care Unit (ICU).
Who may be able to join
- To be 18 years old or older
- Scheduled for cardiac surgery
- Treatment will include 72 hours or more of hospital stay
- Understand enough about the risks and benefits of the study to be able to make an informed decision before agreeing to be in the study
Who cannot join
- History of cerebrovascular disease
- History of skin problems on forehead (skin rashes, acne, allergies, etc.)
- History of craniofacial surgeries
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine Medical Center
Orange, California, 92868
About this study
The purpose of this study is to determine whether a new cerebral oxygenation monitoring device is comparatively similar to the current approved devices.
Read the detailed description
Cerebral oxygenation monitoring is an innovative way to monitoring cardiac surgery patients intraoperatively to reduce the incidence of postoperative hypoxic side effects. There are a number of approved devices already in the market that have proved their efficacy.
- Conditions
- Coronary Artery Disease, Heart Valve Disease
- Being tested
- CDI 1000 COM and INVOS 5100
- Keywords
- Hypoxia, Cerebral Hypoxia
- Medical subject headings
- Coronary Artery Disease, Heart Valve Diseases, Hypoxia, Hypoxia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDI 1000 COM and INVOS 5100Device
Also called Terumo CDI 1000 COM, Somanetics INVOS 5100
CDI 1000 and INVOS 5100 sensors were attached to subject's forehead for a 12 hour period, digital photographs were taken before and after sensor placement.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Surgery or Hospitalization | Patients scheduled for a Cardiac Surgery procedure, two types of cerebral oximetry devices were compared at the same time during the surgical procedure.
The second group were patients hospitalized (in the Intensive Care Unit or ICU, with any diagnosis, excluding head trauma patients. Those patients were monitored using two types of cerebral oximetry devices at the same time for up to 72 hours. Receives: Device: CDI 1000 COM and INVOS 5100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test a new device for Cerebral Oxygenation Monitoring
Measured: 12 hours
Secondary outcomes (1)
Safety of human forehead skin during period of probe adhesion
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionMay 2009
- Study completionMay 2009
Why it stopped: Investigator considered the device with no clinical utility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey C Milliken, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598936
- Sponsor's protocol ID
- 2007-5840
- Status last verified
- Sep 2011
- First submitted
- 24 Dec 2007
- Last updated
- 5 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT00598936
- Acronym / sponsor ID
- 2007-5840
- Conditions
- Coronary Artery Disease, Heart Valve Disease
- Keywords
- Hypoxia, Cerebral Hypoxia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigator considered the device with no clinical utility.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 23 Jan 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 whether a new cerebral oxygenation monitoring device is comparatively similar to the current approved devices.
Detailed description
Cerebral oxygenation monitoring is an innovative way to monitoring cardiac surgery patients intraoperatively to reduce the incidence of postoperative hypoxic side effects. There are a number of approved devices already in the market that have proved their efficacy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Surgery or Hospitalization | – | Device: CDI 1000 COM and INVOS 5100Patients scheduled for a Cardiac Surgery procedure, two types of cerebral oximetry devices were compared at the same time during the surgical procedure. The second group were patients hospitalized (in the Intensive Care Unit or ICU, with any diagnosis, excluding head trauma patients. Those patients were monitored using two types of cerebral oximetry devices at the same time for up to 72 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects ≥18 year-old of age admitted to the University Hospital setting scheduled for cardiac surgery or admitted for any cause to the Intensive Care Unit (ICU).
Key inclusion criteria (4 listed)
- To be 18 years old or older
- Scheduled for cardiac surgery
- Treatment will include 72 hours or more of hospital stay
- Understand enough about the risks and benefits of the study to be able to make an informed decision before agreeing to be in the study
Key exclusion criteria (4 listed)
- History of cerebrovascular disease
- History of skin problems on forehead (skin rashes, acne, allergies, etc.)
- History of craniofacial surgeries
- Pregnancy
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 |
|---|---|---|
| CDI 1000 COM and INVOS 5100Also: Terumo CDI 1000 COM, Somanetics INVOS 5100CDI 1000 and INVOS 5100 sensors were attached to subject's forehead for a 12 hour period, digital photographs were taken before and after sensor placement. | Device | Cardiac Surgery or Hospitalization |
Primary outcome
To test a new device for Cerebral Oxygenation Monitoring
Time frame: 12 hours
1 secondary outcome
Safety of human forehead skin during period of probe adhesion
Time frame: 12 hours
Results and safety
The study was stopped early (reason given: Investigator considered the device with no clinical utility.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2011.
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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.
Jeffrey C Milliken, MD principal investigator
University of California, Irvine
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 Coronary Artery Disease and Heart Valve Disease, run by University of California, Irvine 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 4 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: stopped early, as of the sponsor's last update on 5 Sep 2011. 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 was stopped early (reason given: Investigator considered the device with no clinical utility.). Results are not available in the source record.
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 test a new device for Cerebral Oxygenation Monitoring (time frame: 12 hours). 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 5 Sep 2011.