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NCT00166218 · ClinicalTrials.gov registry record
NIRS Monitoring in the Ambulatory Single Ventricle Patient
A clinical trial, sponsored by Emory University.
- Terminated
- Registry status
- 30
- Enrollment target
NCT00166218 is a clinical trial that was terminated before completion, run by Emory University. The registered enrollment target is 30 participants.
The verdict
NCT00166218 was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- 30 participants
- Enrollment target
Study Summary
The normal heart has four chambers. There are two upper (or filling) chambers and are called the atrium. There are two lower (or pumping) chambers and are called the ventricles. One of the ventricles pumps blood to the lungs to get oxygen. This oxygenated blood is returned to the heart then pumped to the rest of the body by the other ventricle. Sometimes babies are born with heart defects that only allow one of the lower chambers (ventricle) to work properly. This means that the one ventricle must pump blood to both the lungs and to the rest of the body. Babies born with this defect must undergo multiple surgeries, the first of which is usually done during their first week of life. There is a machine that is FDA approved that can measure how much oxygen is delivered to the brain. This non-invasive (outside the body) machine uses Near-infrared spectroscopy (NIRS), which is similar technology used in pulse oximetry and is routinely used to measure the level of oxygen in blood. At Children's Healthcare of Atlanta, we typically place the NIRS machine on the baby in the Cardiac Intensive Care Unit immediately after their first surgery to monitor oxygen delivery to the brain. The monitor has proven to be accurate in this situation. We now want to know if we can use this monitor to assess oxygen delivery to the brain before and during a routine heart catheterization prior to the child's second surgery. Once consent is obtained, we will place a probe on the child's forehead during the pre-catheterization visit and obtain readings for 5 minutes. The probes are about the size of a quarter and are self-stick (they look like the kind of leads used to measure the babies heart rate \[EKG\]). The machine will be disconnected for the rest of the Pre-catheterization visit, however the probes will stay on the child's forehead. Once the child is in the catheterization suite, the machine will be reconnected. A sheath or hollow tube is routinely placed in a blood vessel in the child'
Interventions
- DEVICE near-infrared spectroscopy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2004-02 |
| Est. Completion | 2005-02 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00166218
The ClinicalTrials.gov registry entry for NCT00166218 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which near-infrared spectroscopy is the first listed.
NCT00166218 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00166218 about?
NCT00166218 is a clinical study titled "NIRS Monitoring in the Ambulatory Single Ventricle Patient". The normal heart has four chambers. There are two upper (or filling) chambers and are called the atrium. There are two lower (or pumping) chambers and are called the ventricles. One of the ventricles pumps blood to the lungs to get oxygen. This oxygenated blood is returned to the heart then pumped t...
What is the current status of trial NCT00166218?
This trial is currently terminated. The enrollment target is 30 participants. The study started on 2004-02. Estimated completion is 2005-02.
What interventions are being tested in trial NCT00166218?
The interventions under investigation include: near-infrared spectroscopy (DEVICE).
Who is sponsoring clinical trial NCT00166218?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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