Continuous Jugular Venous Oxygen Saturation (SjO2) Measurement After Cardiac Arrest

NCT06511999 | Recruiting FDA Device

• 1 other identifier: STUDY24040111
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Arrest

Keywords

Jugular venous oxygen saturation; Neuromonitoring

Outcome Measures

Primary Outcomes (1)

• Bias and percent error of continuous SjO2 measurements compared to intermittent SjO2 measurements, both obtained with the PediaSat Oximetry Catheter

  The accuracy of SjO2 measurement with the PediaSat Oximetry Catheter 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 Outcomes (2)

• Proportion of participants in which the PediaSat Oximetry Catheter is successfully inserted and all intermittent and continuous SjO2 measurements are obtained

  From hospital presentation to 72 hours after admission

• Proportion of participants in which all study blood samples are collected, processed, and stored successfully.

  From hospital presentation to 72 hours after admission

Study Arms (1)

Comatose participants resuscitated from cardiac arrest

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 \[PediaSat Oximetry Catheter, Edwards Lifesciences Corp, Irvine, CA\].

Device: Continuous SjO2 monitoring with a PediaSat Oximetry Catheter; Diagnostic Test: Intermittent SjO2 monitoring with a PediaSat Oximetry Catheter

Interventions

Continuous SjO2 monitoring with a PediaSat Oximetry Catheter DEVICE

The PediaSat Oximetry Catheter is capable of continuous, indwelling measurement of venous oxygen saturation, which is displayed on a bedside monitor connected by an optical cable. Enrolled participants will undergo continuous SjO2 measurement for 72 hours. Clinical care will not be directed by the continuous SjO2 values.

Comatose participants resuscitated from cardiac arrest

Intermittent SjO2 monitoring with a PediaSat Oximetry Catheter DIAGNOSTIC_TEST

The PediaSat Oximetry Catheter is also capable of intermittent blood sampling enabling measurement of SjO2 on a laboratory blood gas analyzer. Enrolled participants will undergo intermittent SjO2 measurement every 4-6 hours for 72 hours. Clinical care will be directly by the intermittent values.

Comatose participants resuscitated from cardiac arrest

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients successfully resuscitated from cardiac arrest

You may qualify if:

• 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.

You may not qualify if:

• Cardiac arrest due to traumatic brain injury, intracranial bleeding, or ischemic stroke
• Cervical spine fracture
• Need for immediate prone positioning for severe hypoxemic respiratory failure
• Marked hemodynamic instability precluding priority of any neuromonitoring (multiple recurrent cardiac arrests, norepinephrine equivalents \> 1.5 mcg/kg/min)
• Moribund neurological status based upon initial clinical, radiographic and historical assessment (e.g. diffuse cerebral edema or herniation on head computed tomography)
• Pregnancy
• Prisoners

Sponsors & Collaborators

• Byron Drumheller: lead

Study Sites (1)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Related Publications (8)

• Skrifvars MB, Sekhon M, Aneman EA. Monitoring and modifying brain oxygenation in patients at risk of hypoxic ischaemic brain injury after cardiac arrest. Crit Care. 2021 Aug 31;25(1):312. doi: 10.1186/s13054-021-03678-3.

  PMID: 34461973 BACKGROUND

• Le Roux P, Menon DK, Citerio G, Vespa P, Bader MK, Brophy G, Diringer MN, Stocchetti N, Videtta W, Armonda R, Badjatia N, Bosel J, Chesnut R, Chou S, Claassen J, Czosnyka M, De Georgia M, Figaji A, Fugate J, Helbok R, Horowitz D, Hutchinson P, Kumar M, McNett M, Miller C, Naidech A, Oddo M, Olson D, O'Phelan K, Provencio JJ, Puppo C, Riker R, Roberson C, Schmidt M, Taccone F. The International Multidisciplinary Consensus Conference on Multimodality Monitoring in Neurocritical Care: a list of recommendations and additional conclusions: a statement for healthcare professionals from the Neurocritical Care Society and the European Society of Intensive Care Medicine. Neurocrit Care. 2014 Dec;21 Suppl 2(Suppl 2):S282-96. doi: 10.1007/s12028-014-0077-6.

  PMID: 25501689 BACKGROUND

• Hoiland RL, Ainslie PN, Wellington CL, Cooper J, Stukas S, Thiara S, Foster D, Fergusson NA, Conway EM, Menon DK, Gooderham P, Hirsch-Reinshagen V, Griesdale DE, Sekhon MS. Brain Hypoxia Is Associated With Neuroglial Injury in Humans Post-Cardiac Arrest. Circ Res. 2021 Aug 20;129(5):583-597. doi: 10.1161/CIRCRESAHA.121.319157. Epub 2021 Jul 21.

  PMID: 34287000 BACKGROUND

• Sekhon MS, Ainslie PN, Menon DK, Thiara SS, Cardim D, Gupta AK, Hoiland RL, Gooderham P, Griesdale DE. Brain Hypoxia Secondary to Diffusion Limitation in Hypoxic Ischemic Brain Injury Postcardiac Arrest. Crit Care Med. 2020 Mar;48(3):378-384. doi: 10.1097/CCM.0000000000004138.

  PMID: 31789834 BACKGROUND

• Richter J, Sklienka P, Chatterjee N, Maca J, Zahorec R, Burda M. Elevated jugular venous oxygen saturation after cardiac arrest. Resuscitation. 2021 Dec;169:214-219. doi: 10.1016/j.resuscitation.2021.10.011. Epub 2021 Oct 19.

  PMID: 34678332 BACKGROUND

• Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.

  PMID: 2868172 BACKGROUND

• Howard L, Gopinath SP, Uzura M, Valadka A, Robertson CS. Evaluation of a new fiberoptic catheter for monitoring jugular venous oxygen saturation. Neurosurgery. 1999 Jun;44(6):1280-5.

  PMID: 10371628 BACKGROUND

• Bland JM, Altman DG. Agreement between methods of measurement with multiple observations per individual. J Biopharm Stat. 2007;17(4):571-82. doi: 10.1080/10543400701329422.

  PMID: 17613642 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be withdrawn from the jugular venous catheter at 0, 24, 48 and 72 hours after insertion for measurement of protein biomarkers associated with secondary brain injury after cardiac arrest.

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Byron Drumheller, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Byron Drumheller, MD

CONTACT

1-301-461-9301; drumhellerbc@upmc.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 22, 2024
• Study Start: September 20, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 8, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)