Continuous SjO2 Monitoring for Cardiac Arrest
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a special catheter can accurately measure brain oxygen levels in real-time for patients who are comatose after being revived from cardiac arrest. Researchers compare this new method to the standard approach, which involves drawing blood and sending it to the lab. This advancement could enable doctors to address brain oxygen issues more swiftly. Individuals resuscitated from cardiac arrest and still comatose may be suitable candidates for the trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking medical advancements.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this catheter is safe for monitoring SjO2 in comatose patients?
Research has shown that the PediaSat Oximetry Catheter is generally well-tolerated by patients. The FDA has approved this device for continuous monitoring of blood oxygen levels. Past studies used it to track oxygen levels without repeated blood draws. These studies found no major safety issues, suggesting the catheter is safe for this purpose. However, like any medical device, it carries risks, such as infection or irritation at the insertion site, though these are usually rare. Overall, the catheter has proven to be a reliable tool for continuous oxygen level monitoring.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a novel way to monitor brain oxygen levels in comatose patients after cardiac arrest. Unlike traditional methods that might not provide continuous feedback, this technique uses the PediaSat Oximetry Catheter to offer real-time monitoring of jugular venous oxygen saturation (SjO2). This continuous monitoring could potentially provide more accurate and timely insights into a patient's brain oxygen levels, which might improve decision-making during critical care. By understanding these oxygen levels better, clinicians hope to enhance patient outcomes after cardiac arrest.
What evidence suggests that this catheter is effective for monitoring brain oxygen levels in comatose patients after cardiac arrest?
In this trial, comatose participants resuscitated from cardiac arrest will undergo jugular venous oxygen saturation (SjO2) monitoring with the PediaSat Oximetry Catheter. Research has shown that the PediaSat Oximetry Catheter can continuously monitor blood oxygen levels, aiding in the management of low tissue oxygen. Studies have found that this catheter provides real-time information, enabling doctors to respond quickly to changes in a patient's condition. A major benefit is its ability to measure oxygen levels in the veins without drawing blood. This feature is especially useful for patients who have just survived a heart attack, as it helps detect brain oxygen issues early. The catheter has proven accurate compared to traditional lab methods, making it a promising tool for improving patient care.13467
Who Is on the Research Team?
Byron Drumheller, MD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Continuous monitoring of jugular venous oxygen saturation (SjO2) using the TriOx PICC catheter for 72 hours
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PediaSat Oximetry Catheter
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants successfully resuscitated from cardiac arrest that are comatose (motor glasgow coma scale \<= 4) upon initial assessment will undergo jugular venous oxygen saturation (SjO2) monitoring with the study device \[PediaSat Oximetry Catheter, Edwards Lifesciences Corp, Irvine, CA\].
Find a Clinic Near You
Who Is Running the Clinical Trial?
Byron Drumheller
Lead Sponsor
Citations
Continuous Jugular Venous Oxygen Saturation (SjO2) ...
Patients successfully resuscitated from sudden cardiac arrest are often comatose, having suffered a period of low blood flow and oxygen delivery to the ...
the PediaSat single-center randomized trial - PMC
Patients in the intervention group were managed using the PediaSat oximetry catheter, which provided continuous central venous Oxygen Saturation ...
3.
edwards.com
edwards.com/ca-en/healthcare-professionals/products-services/hemodynamic-monitoring/pediasat-oximetry-catheterPediaSat Oximetry Catheter
PediaSat oximetry catheter is the first and only pediatric oximetry catheter with continuous ScvO 2 monitoring for proactive management of tissue hypoxia.
Prognostic significance of the difference between mixed ...
The positive predictive value of (SmvO2-SjO2) < or = 0 for predicting irreversible brain damage at 24 h after cardiac arrest is 93%.
5.
researchgate.net
researchgate.net/publication/47337100_Evaluation_of_a_new_pediatric_continuous_oximetry_catheterEvaluation of a new pediatric continuous oximetry catheter
The present study compares the accuracy of a new continuous venous oxygenation monitoring system (PediaSat Oximetry Catheter) with laboratory ...
6.
edwards.com
edwards.com/healthcare-professionals/products-services/hemodynamic-monitoring/pediasat-oximetry-catheterPediaSat Oximetry Catheter
PediaSat oximetry catheter is the first and only pediatric oximetry catheter with continuous ScvO 2 monitoring for proactive management of tissue hypoxia.
Monitoring of Cerebral Oxygenation Using Jugular ...
The objective of this study is to assess the relationship between jugular venous oximetry and neurological outcome of comatose patients after cardiac arrest, ...
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