A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Cardiac Surgery Patients
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine whether a new cerebral oxygenation monitoring device is comparatively similar to the current approved devices.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease Heart Valve Disease |
Device: CDI 1000 COM and INVOS 5100 |
Phase 1 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Cardiac Surgery Patients |
- To test a new device for Cerebral Oxygenation Monitoring [ Time Frame: 12 hours ] [ Designated as safety issue: Yes ]
- Safety of human forehead skin during period of probe adhesion [ Time Frame: 12 hours ] [ Designated as safety issue: Yes ]
| Enrollment: | 21 |
| Study Start Date: | November 2007 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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. |
Device: CDI 1000 COM and 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.
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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).
Inclusion Criteria:
- 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
Exclusion Criteria:
- History of cerebrovascular disease
- History of skin problems on forehead (skin rashes, acne, allergies, etc.)
- History of craniofacial surgeries
- Pregnancy
Contacts and Locations| United States, California | |
| University of California, Irvine Medical Center | |
| Orange, California, United States, 92868 | |
| Principal Investigator: | Jeffrey C Milliken, MD | University of California, Irvine |
More Information
No publications provided
| Responsible Party: | University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00598936 History of Changes |
| Other Study ID Numbers: | 2007-5840 |
| Study First Received: | December 24, 2007 |
| Last Updated: | September 1, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Irvine:
|
Hypoxia Cerebral Hypoxia |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Valve Diseases Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013