Continuous Jugular Venous Oxygen Saturation (SjO2) Measurement After Cardiac Arrest
NCT Number: NCT06511999
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiac Arrest
Interventions: DEVICE: Continuous SjO2 monitoring with a TriOx PICC catheter|DIAGNOSTIC_TEST: Intermittent SjO2 monitoring with a TriOx PICC catheter
Sponsor: Byron Drumheller
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-12
Locations: UPMC Presbyterian Hospital, Pittsburgh, Pennsylvania, 15213, United States

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.

Primary Outcome Measures: Bias and percent error of continuous SjO2 measurements compared to intermittent SjO2 measurements, both obtained with the TriOX PICC, The accuracy of SjO2 measurement with the TriOx PICC will be determined by comparing the SjO2 measurements obtained from the study catheter with the gold standard of SjO2 measured on jugular venous blood simultaneously withdrawn from the catheter and analyzed on a blood gas machine. Each participant will have \~10-15 paired SjO2 measurements. The Bland-Altman method for assessing agreement between two methods of clinical measurement with multiple observations per participant will be utilized to calculate the bias between the mean differences of the continuous and intermittent techniques and the percent error of the continuous technique. Based on established accuracy requirements for similar continuous in-vivo measurements in critical care, a bias of \<= ± 5 and a percent error of \<= 30 will be considered successful., From hospital presentation to 72 hours after admission
Secondary Outcome Measures: Proportion of participants in which the TriOx PICC is successfully inserted and all intermittent and continuous SjO2 measurements are obtained, Feasibility will be measured by calculating the proportion of participants in which the TriOx PICC is successfully inserted and SjO2 data is successfully collected for 72 hours, as determined by routine clinical care. For an individual participant to achieve feasibility, the catheter must be correctly inserted and all intermittent and continuous SjO2 measurements ordered as part of clinical care must be measured successfully. The study goal is for \>= 75 percent of participants to achieve feasibility., From hospital presentation to 72 hours after admission|Proportion of participants in which all study blood samples are collected, processed, and stored successfully., Feasibility of obtaining serial jugular venous blood samples during the first 72 hours of post-arrest care and storage of plasma for subsequent biomarker analysis will be measured by calculating the proportion of participants in which all 4 study blood samples are collected, processed, and successfully stored. The study goal is for \>= 75 percent of participants to achieve feasibility., From hospital presentation to 72 hours after admission