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NCT00815490 · ClinicalTrials.gov registry record · NA
Validation of Brain Oxygenation Monitor
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT00815490: Completed NA study, sponsored by Duke University.
NCT00815490 is a NA study that has completed, run by Duke University. The registered enrollment target is 18 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00815490, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study Summary
A cerebral oximeter is a device that uses light to measure the amount of oxygen within the brain. It is similar to the device that measures the level of oxygen in the tip of the finger, known as a pulse oximeter. The cerebral oximeter consists of a sensor placed on the forehead that both emits and detects the amount of light absorbed. This study will determine how accurate the device is by comparing the displayed value on the monitor with blood samples taken simultaneously from the arterial blood in the wrist and venous blood in the neck. In order to test the device over a suitable range, the level of oxygen within the blood will be reduced in a controlled manner by reduction of the inspired oxygen concentration. This is the equivalent of ascending to an altitude of 16,000 feet. The study will be conducted in healthy volunteers.
Primary Outcome
A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around this line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square or ARMS. The smaller the ARMS the closer the data points lie around the li
Interventions
- DEVICE Desaturation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2008-06 |
| Est. Completion | 2012-04 |
| Phase | NA |
What the finished NCT00815490 record still lists
NCT00815490 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Desaturation is the first listed.
NCT00815490 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00815490 about?
NCT00815490 is a clinical study titled "Validation of Brain Oxygenation Monitor". A cerebral oximeter is a device that uses light to measure the amount of oxygen within the brain. It is similar to the device that measures the level of oxygen in the tip of the finger, known as a pulse oximeter. The cerebral oximeter consists of a sensor placed on the forehead that both emits and d...
What is the current status of trial NCT00815490?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2008-06. Estimated completion is 2012-04.
What interventions are being tested in trial NCT00815490?
The interventions under investigation include: Desaturation (DEVICE).
Who is sponsoring clinical trial NCT00815490?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00815490's enrollment target sits among peer trials
18 1863rd of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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