Cardiac ArrestNCT06511999
Continuous Jugular Venous Oxygen Saturation (SjO2) Measurement After Cardiac Arrest
An observational study of Cardiac Arrest, run by Byron Drumheller at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Continuous SjO2 monitoring with a PediaSat Oximetry Catheter and Intermittent SjO2 monitoring with a PediaSat Oximetry Catheter
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients successfully resuscitated from cardiac arrest
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
Byron Drumheller, MD, 1-301-461-9301, drumhellerbc@upmc.edu
About this study
Official title: Feasibility and Validation of Continuous Measurement of Jugular Venous Oxygen Saturation in Comatose Patients After Cardiac Arrest
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.
Read the detailed description
Patients who achieve return of spontaneous circulation (ROSC) after sudden cardiac arrest and remain comatose are at high risk of secondary brain injury that may prevent or worsen the quality of neurological recovery. Current treatments that attempt to mitigate the extent of secondary brain injury include targeted temperature management (TTM), maintenance of adequate blood pressure and gas exchange (oxygen and carbon dioxide), and antiepileptic treatment of seizures and other hyperexcitable patterns detected on electroencephalographic (EEG) monitoring. Multiple recent large-scale clinical trials comparing different magnitudes of such therapies (mild hypothermia vs. controlled normothermia or fever prevention, aggressive antiseizure treatment of rhythmic/periodic patterns vs. no treatment) or resuscitation targets (oxygen, carbon dioxide, and blood pressure goals) did not detect improvement in neurologic outcome with the hypothesized superior interventions. Research from the investigators and others suggests that between-patient heterogeneity in patterns and severity of hypoxic-ischemic brain injury (HIBI) after cardiac arrest may explain the repeated failure to find a population-level benefit of any particular one-size-fits-all therapy: individual patients exhibit differing pathophysiology and may respond best to different neuroprotective interventions.
To tailor potential neuroprotective treatments to individual patients, doctors must be able to detect and characterize neurological pathophysiology and treatment responsiveness in real time. This requires use of one or more prospective neuromonitoring modalities, including measurement of jugular venous oxygen saturation (SjO2). Measurement of SjO2 involves inserting a catheter retrograde into the internal jugular vein and determining the oxygen saturation of blood just after it leaves the skull. By comparing the SjO2 with the saturation of arterial blood (SaO2) entering the brain, measured from a large artery, the percentage of oxygen extracted by the brain can be determined (SaO2 - SjO2). This is akin to measuring central venous oxygen saturation (ScvO2) in various types of circulatory shock. Measurement of SjO2 early after cardiac arrest provides information on the balance between brain-specific oxygen supply, utilization, and demand. Identification of abnormal brain oxygen balance during this time period in which secondary brain injury is most likely to occur can trigger and guide potentially corrective therapies.
The Post Cardiac Arrest Service (PCAS) at UPMC Presbyterian uses SjO2 monitoring in comatose patients after cardiac arrest as part of routine prognostic and therapeutic purposes for the first 72 hours of hospitalization. Prior research has shown a significant association between elevated mean SjO2 (>75%) during the early post-arrest period and poor outcomes. It is hypothesized that this represents either poor brain oxygen extraction resulting from abnormalities in diffusion through peri-neuronal tissue or impaired mitochondrial oxygen uptake and utilization, leading to elevated oxygen saturation/content in venous blood leaving the injured brain. Preliminary case series by the investigators and Hoiland et al. have shown that some patients with elevated SjO2 exhibit a decrease in SjO2, and concomitant increase in brain oxygen utilization, after treatment with hypertonic saline (HTS), suggesting that abnormal oxygen diffusion due to perivascular edema plays some part in the pathophysiology of post-arrest HIBI.
The ability to detect and act upon abnormal brain oxygen balance, particularly oxygenation changes that may result from potential neuroprotective interventions, is limited by current SjO2 measurement technology. Presently, SjO2 is measured by withdrawing blood from a single lumen, 3-4 French, 10-15 cm-long catheter on an intermittent basis every 4-6 hours and calculating venous oxygen saturation from the blood sample on a blood gas analyzer in the hospital laboratory. As a result, SjO2 data granularity is limited by the practical frequency of blood draws and lab result turn-around time. However, vascular catheter technology allowing for continuous, in-dwelling measurement of venous blood oxygen saturation via spectrophotometry exists and is routinely used to monitor central venous oxygen saturation (ScvO2) and mixed venous oxygen saturation (SvO2) in patients with cardiogenic shock. Specifically, an FDA-cleared, continuous venous oximetry-enabled, central venous catheter [PediaSat™ Oximetry Catheter, Edwards Lifesciences Corp, Irvine, CA] [triple lumen, 5.5 French, 15 cm] is currently used for measurement of ScVO2 in pediatric patients with cardiogenic or septic shock. This catheter also allows for intermittent blood sampling. The investigators seek to translate this existing continuous venous oximetry technology for use in the measurement of SjO2. To do so, the investigators plan to perform a prospective, observational, case series study to determine the feasibility and accuracy of continuous measurement of SjO2 with the PediaSat™ Oximetry Catheter , compared to the standard technique of measurement via blood sampling analysis on a laboratory blood gas machine, in comatose participants at risk of secondary brain injury after cardiac arrest. The investigators also plan to demonstrate the feasibility of obtaining and storing jugular blood samples using the continuous SjO2 catheter for future biomarker analysis.
- Conditions
- Cardiac Arrest
- Being tested
- Continuous SjO2 monitoring with a PediaSat Oximetry Catheter, Intermittent SjO2 monitoring with a PediaSat Oximetry Catheter
- Keywords
- Jugular venous oxygen saturation, Neuromonitoring
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous SjO2 monitoring with a PediaSat Oximetry CatheterDevice
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.
Intermittent SjO2 monitoring with a PediaSat Oximetry CatheterDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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]. Receives: Device: Continuous SjO2 monitoring with a PediaSat Oximetry Catheter; Diagnostic Test: Intermittent SjO2 monitoring with a PediaSat Oximetry Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Feasibility will be measured by calculating the proportion of participants in which the PediaSat Oximetry Catheter 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.
Measured: 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.
Measured: From hospital presentation to 72 hours after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start20 Sep 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Byron Drumheller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Byron Drumheller, University of Pittsburgh
- Investigators
- Byron Drumheller, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511999
- Sponsor's protocol ID
- STUDY24040111
- Status last verified
- Jun 2026
- First submitted
- 15 Jul 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34461973Le 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.
PubMed 25501689Hoiland 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.
PubMed 34287000Sekhon 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.
PubMed 31789834Richter 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.
PubMed 34678332Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
PubMed 2868172Howard 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.
PubMed 10371628Bland 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.
PubMed 17613642
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Validation of Continuous Measurement of Jugular Venous Oxygen Saturation in Comatose Patients After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT06511999
- Acronym / sponsor ID
- STUDY24040111
- Conditions
- Cardiac Arrest
- Keywords
- Jugular venous oxygen saturation, Neuromonitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Byron DrumhellerUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients who achieve return of spontaneous circulation (ROSC) after sudden cardiac arrest and remain comatose are at high risk of secondary brain injury that may prevent or worsen the quality of neurological recovery. Current treatments that attempt to mitigate the extent of secondary brain injury include targeted temperature management (TTM), maintenance of adequate blood pressure and gas exchange (oxygen and carbon dioxide), and antiepileptic treatment of seizures and other hyperexcitable patterns detected on electroencephalographic (EEG) monitoring. Multiple recent large-scale clinical trials comparing different magnitudes of such therapies (mild hypothermia vs. controlled normothermia or fever prevention, aggressive antiseizure treatment of rhythmic/periodic patterns vs. no treatment) or resuscitation targets (oxygen, carbon dioxide, and blood pressure goals) did not detect improvement in neurologic outcome with the hypothesized superior interventions. Research from the investigators and others suggests that between-patient heterogeneity in patterns and severity of hypoxic-ischemic brain injury (HIBI) after cardiac arrest may explain the repeated failure to find a population-level benefit of any particular one-size-fits-all therapy: individual patients exhibit differing pathophysiology and may respond best to different neuroprotective interventions.
To tailor potential neuroprotective treatments to individual patients, doctors must be able to detect and characterize neurological pathophysiology and treatment responsiveness in real time. This requires use of one or more prospective neuromonitoring modalities, including measurement of jugular venous oxygen saturation (SjO2). Measurement of SjO2 involves inserting a catheter retrograde into the internal jugular vein and determining the oxygen saturation of blood just after it leaves the skull. By comparing the SjO2 with the saturation of arterial blood (SaO2) entering the brain, measured from a large artery, the percentage of oxygen extracted by the brain can be determined (SaO2 - SjO2). This is akin to measuring central venous oxygen saturation (ScvO2) in various types of circulatory shock. Measurement of SjO2 early after cardiac arrest provides information on the balance between brain-specific oxygen supply, utilization, and demand. Identification of abnormal brain oxygen balance during this time period in which secondary brain injury is most likely to occur can trigger and guide potentially corrective therapies.
The Post Cardiac Arrest Service (PCAS) at UPMC Presbyterian uses SjO2 monitoring in comatose patients after cardiac arrest as part of routine prognostic and therapeutic purposes for the first 72 hours of hospitalization. Prior research has shown a significant association between elevated mean SjO2 (>75%) during the early post-arrest period and poor outcomes. It is hypothesized that this represents either poor brain oxygen extraction resulting from abnormalities in diffusion through peri-neuronal tissue or impaired mitochondrial oxygen uptake and utilization, leading to elevated oxygen saturation/content in venous blood leaving the injured brain. Preliminary case series by the investigators and Hoiland et al. have shown that some patients with elevated SjO2 exhibit a decrease in SjO2, and concomitant increase in brain oxygen utilization, after treatment with hypertonic saline (HTS), suggesting that abnormal oxygen diffusion due to perivascular edema plays some part in the pathophysiology of post-arrest HIBI.
The ability to detect and act upon abnormal brain oxygen balance, particularly oxygenation changes that may result from potential neuroprotective interventions, is limited by current SjO2 measurement technology. Presently, SjO2 is measured by withdrawing blood from a single lumen, 3-4 French, 10-15 cm-long catheter on an intermittent basis every 4-6 hours and calculating venous oxygen saturation from the blood sample on a blood gas analyzer in the hospital laboratory. As a result, SjO2 data granularity is limited by the practical frequency of blood draws and lab result turn-around time. However, vascular catheter technology allowing for continuous, in-dwelling measurement of venous blood oxygen saturation via spectrophotometry exists and is routinely used to monitor central venous oxygen saturation (ScvO2) and mixed venous oxygen saturation (SvO2) in patients with cardiogenic shock. Specifically, an FDA-cleared, continuous venous oximetry-enabled, central venous catheter [PediaSat™ Oximetry Catheter, Edwards Lifesciences Corp, Irvine, CA] [triple lumen, 5.5 French, 15 cm] is currently used for measurement of ScVO2 in pediatric patients with cardiogenic or septic shock. This catheter also allows for intermittent blood sampling. The investigators seek to translate this existing continuous venous oximetry technology for use in the measurement of SjO2. To do so, the investigators plan to perform a prospective, observational, case series study to determine the feasibility and accuracy of continuous measurement of SjO2 with the PediaSat™ Oximetry Catheter , compared to the standard technique of measurement via blood sampling analysis on a laboratory blood gas machine, in comatose participants at risk of secondary brain injury after cardiac arrest. The investigators also plan to demonstrate the feasibility of obtaining and storing jugular blood samples using the continuous SjO2 catheter for future biomarker analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comatose participants resuscitated from cardiac arrest | – | Device: Continuous SjO2 monitoring with a PediaSat Oximetry Catheter, Diagnostic Test: Intermittent SjO2 monitoring with a PediaSat Oximetry CatheterParticipants 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]. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients successfully resuscitated from cardiac arrest
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous SjO2 monitoring with a PediaSat Oximetry CatheterThe 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. | Device | Comatose participants resuscitated from cardiac arrest |
| Intermittent SjO2 monitoring with a PediaSat Oximetry CatheterThe 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. | Diagnostic test | Comatose participants resuscitated from cardiac arrest |
Primary outcome
Bias and percent error of continuous SjO2 measurements compared to intermittent SjO2 measurements, both obtained with the PediaSat Oximetry Catheter
Time frame: From hospital presentation to 72 hours after admission
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.
2 secondary outcomes
Proportion of participants in which the PediaSat Oximetry Catheter is successfully inserted and all intermittent and continuous SjO2 measurements are obtained
Time frame: From hospital presentation to 72 hours after admission
Proportion of participants in which all study blood samples are collected, processed, and stored successfully.
Time frame: From hospital presentation to 72 hours after admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Background: PubMed 34461973Skrifvars 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.
- Background: PubMed 25501689Le 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.
- Background: PubMed 34287000Hoiland 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.
- Background: PubMed 31789834Sekhon 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.
- Background: PubMed 34678332Richter 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.
- Background: PubMed 2868172Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
- Background: PubMed 10371628Howard 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.
- Background: PubMed 17613642Bland 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.
- Individual participant dataSharing planned: No
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Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Byron Drumheller, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by Byron Drumheller at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Byron Drumheller, MD (1-301-461-9301, drumhellerbc@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bias and percent error of continuous SjO2 measurements compared to intermittent SjO2 measurements, both obtained with the PediaSat Oximetry Catheter (time frame: From hospital presentation to 72 hours after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06511999, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.