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Comatose participants resuscitated from cardiac arrest for Heart Attack

N/A
Waitlist Available
Led By Byron Drumheller, MD
Research Sponsored by Byron Drumheller
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
• Adults (\>=18 years old) resuscitated from out-of-hospital or in-hospital cardiac arrest who remain comatose (motor Glasgow coma scale \<=4) for at least 30 minutes when examined off sedation/neuromuscular blockade.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from hospital presentation to 72 hours after admission
Awards & highlights
No Placebo-Only Group

Summary

Patients successfully resuscitated from sudden cardiac arrest are often comatose, having suffered a period of low blood flow and oxygen delivery to the brain. They are also at risk of suffering further brain injury during the immediate period after resuscitation, in which the brain's normal regulatory functions are impaired. To diagnose and treat secondary brain injury in comatose patients after cardiac arrest, doctors use a variety of neurological monitoring techniques. One of these methods involves measuring the oxygen saturation of blood going into and out of the brain to determine whether the brain is receiving and utilizing oxygen in an optimal manner. The oxygen saturation of blood exiting the brain is called the jugular venous oxygen saturation (SjO2). It is measured by inserting a catheter into the jugular vein in the neck and sampling blood as it exits the skull. The blood sample is sent to the hospital laboratory and the oxygen saturation is measured on a blood gas machine. This method of SjO2 measurement has limitations, particularly that blood must be taken out of the patient and sent to the lab for analysis, which can only be done feasibly every few hours. Special catheters exist that can measure the oxygen saturation of blood passing by the tip of the catheter inside the patient on a second-by-second basis, without needing to withdraw blood and send it to the laboratory. With such rapidly available data, doctors may be able to better diagnose and treat brain oxygen abnormalities in post cardiac arrest patients. In this study, the investigators plan to determine the accuracy of an existing, Food and Drug Administration (FDA)-cleared catheter capable of continuous, indwelling measurement of venous blood oxygen saturation for SjO2 monitoring in comatose patients early after cardiac arrest. The SjO2 measurements from the study catheter will be compared with standard SjO2 measurements made by withdrawing blood and analyzing it in the laboratory to determine if the new catheter is accurate. The investigators will also collect blood samples using the study catheter to measure levels of specific proteins that indicate damage to brain tissue. The study will enroll 25 participants admitted to the intensive care unit at one hospital cared for by a group of doctors that specialize in the neurological care of patients after cardiac arrest. The investigators hypothesize that the study catheter will accurately measure SjO2 compared to the standard laboratory method.

Eligible Conditions
  • Heart Attack

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from hospital presentation to 72 hours after admission
This trial's timeline: 3 weeks for screening, Varies for treatment, and from hospital presentation to 72 hours after admission for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Bias and percent error of continuous SjO2 measurements compared to intermittent SjO2 measurements, both obtained with the TriOX PICC
Secondary study objectives
Proportion of participants in which all study blood samples are collected, processed, and stored successfully.
Proportion of participants in which the TriOx PICC is successfully inserted and all intermittent and continuous SjO2 measurements are obtained

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Comatose participants resuscitated from cardiac arrestExperimental Treatment2 Interventions
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 \[TriOx PICC, ICU medical, San Clemente, CA\].

Find a Location

Who is running the clinical trial?

Byron DrumhellerLead Sponsor
Byron Drumheller, MDPrincipal InvestigatorUniversity of Pittsburgh
~17 spots leftby Dec 2025