EpilepsyNCT02241798
Pre-oxygenation and Measures of Gas Exchanges During Seizures in the Epilepsy Monitoring Unit
A study testing oxygen in people with Epilepsy, run by NYU Langone Health at 1 site in United States.
Trial summary
The primary goal of the study is to assess the effect of pre-oxygenation on oxygen and carbon dioxide levels during seizures in patients admitted at the Epilepsy Monitoring Unit (EMU). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 18-70 yo admitted for monitoring and capturing seizures at the EMU with scalp electrodes and for seizure localization with implantation of intracranial electrodes.
Who cannot join
- patients who are considered healthy enough to provoke seizure activity will have few medical illnesses severe enough to be of concern with respect to continuous oxygen delivery. However, patients will be screened for moderate to severe chronic obstructive pulmonary disease and excluded, as their minute ventilation may decrease and CO2 levels increased with continuous oxygen supplementation.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center
New York, New York, 10016
About this study
Official title: Effects of Pre-oxygenation on Indicators of Gas Exchange and Autonomic Function During Seizures in the Epilepsy Unit
The primary goal of the study is to assess the effect of pre-oxygenation on oxygen and carbon dioxide levels during seizures in patients admitted at the Epilepsy Monitoring Unit (EMU). The investigators hypothesize that providing oxygen prior to seizures will help eliminate the drops in changes seen during seizures, such as the drop in oxygen saturation and increase in carbon dioxide levels.
Research will be done on patients that are admitted to the EMU specifically to have seizures occur and to be recorded on video electroencephalography (vEEG), and the only research intervention will be the use of oxygen prior to some of the seizures.
Read more
The importance of this research relates to the phenomenon of sudden unexplained death in epilepsy patients (SUDEP). SUDEP cases are typically patients with epilepsy who are found dead by their families in the morning, without a clear cause for death. The risk of SUDEP is as high as 9.3 per 1000 person-years (Shorvon and Tomson 2011). There may be multiple mechanisms for SUDEP to occur, however a leading hypothesis is a decrease in ventilation during the seizure leading to hypoxia. Blood oxygen saturation levels have been found to decrease significantly in 25-50% of patients during or shortly after a seizure while being monitored in hospitals. In rare situations, a significantly lowered oxygen level may trigger a cascade of events from which the body may not be able to recover, leading to SUDEP. In animal models, providing oxygen prior to seizures occurring has been shown to eliminate oxygen desaturation, but more importantly eliminate mortality in animals prone to death due to seizures.
Pre-oxygenation is a standard procedure during rapid-sequence induction anesthesia as it reduces the risk of oxygen desaturation during the apneic period of the procedure. On room air, the estimated duration of safe apnea is 1 minute, but this can increase to 8 minutes following pre-treatment with high FiO2 (Weingart and Levitan 2012). This is primarily due to oxygen replacing nitrogen within alveoli, creating a reservoir of oxygen within the lungs from which transfer to the bloodstream can continue despite the lack of ventilation. The apneic episode during seizures should benefit from the same principle.
The main purpose of the Epilepsy Monitoring Unit (EMU) is to evaluate patients to better characterize seizures, to identify the main seizure focus. In addition to standard EEG with electrodes on the scalp, some patients require invasive localization of the epileptic focus by surgically placing electrodes within the skull (often referred to as GRID patients) on or within the brain, with the goal of being able to resect the area that is causing seizures. To identify where seizure originate electrically, it requires that seizures occur during the vEEG procedure. To provoke seizures, medications are typically lowered, and both partial seizures and those with secondary generalization to full tonic-clonic (GTC) seizures will occur. Prior research has shows that oxygen desaturation below 90% occurs with some complex partial seizures, but hypoxia is more common and more profound with GTCs. Some centers use oxygen saturation and CO2 monitors as their standard of care, and at NYULMC the investigators also have the capability for both for clinical usage.
Oxygen is not currently a mandated standard-of-care, but is often provided by nasal prongs following seizures as part of the post-ictal nursing care, though there is no outcome data to support its use. It is unknown whether pre-treatment with oxygen will reduce the rate of oxygen desaturations clinically, as seen in animal models, and this is the goal of this research project.
- Conditions
- Epilepsy
- Being tested
- oxygen
- Keywords
- epilepsy, oxygen saturation, transcutaneous carbon dioxide, sudep, pre-oxygenation
- Medical subject headings
- Epilepsy, Sudden Unexpected Death in Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygenOther
O2 by nasal prongs
| Study group | Role | What they receive |
|---|---|---|
| Pre-oxygenation first | Experimental | 1. st, 3rd, 5th, etc seizure: continuous 'pre-oxygenation' up to 4L O2 nasal prongs, as tolerated
2. nd, 4th, 6th, etc seizure: Standard practice (O2 only in post-ictal period). Receives: Other: oxygen |
| Standard practice first | Experimental | 1. st, 3rd, 5th, etc seizure: Standard practice (O2 only in post-ictal period).
2. nd, 4th, 6th, etc seizure: continuous 'pre-oxygenation' up to 4L O2 nasal prongs, as tolerated Receives: Other: oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen desaturation below 92% following GTCs
Measured: during and up to 6 minutes following the seizure
Secondary outcomes (1)
Oxygen Desaturations below 80% following GTCs
Measured: during and up to 6 minutes following seizures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startAug 2013
- Primary completionAug 2014
- Study completionMar 2016
Why it stopped: Investigator is leaving the institution and has terminated the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241798
- Sponsor's protocol ID
- S13-00435
- Status last verified
- Mar 2017
- First submitted
- 12 Sep 2014
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pre-oxygenation on Indicators of Gas Exchange and Autonomic Function During Seizures in the Epilepsy Unit
- ClinicalTrials.gov ID
- NCT02241798
- Acronym / sponsor ID
- S13-00435
- Conditions
- Epilepsy
- Keywords
- epilepsy, oxygen saturation, transcutaneous carbon dioxide, sudep, pre-oxygenation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator is leaving the institution and has terminated the study.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 16 Sep 2014 (estimated)
- 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.
The primary goal of the study is to assess the effect of pre-oxygenation on oxygen and carbon dioxide levels during seizures in patients admitted at the Epilepsy Monitoring Unit (EMU). The investigators hypothesize that providing oxygen prior to seizures will help eliminate the drops in changes seen during seizures, such as the drop in oxygen saturation and increase in carbon dioxide levels.
Research will be done on patients that are admitted to the EMU specifically to have seizures occur and to be recorded on video electroencephalography (vEEG), and the only research intervention will be the use of oxygen prior to some of the seizures.
The importance of this research relates to the phenomenon of sudden unexplained death in epilepsy patients (SUDEP). SUDEP cases are typically patients with epilepsy who are found dead by their families in the morning, without a clear cause for death. The risk of SUDEP is as high as 9.3 per 1000 person-years (Shorvon and Tomson 2011). There may be multiple mechanisms for SUDEP to occur, however a leading hypothesis is a decrease in ventilation during the seizure leading to hypoxia. Blood oxygen saturation levels have been found to decrease significantly in 25-50% of patients during or shortly after a seizure while being monitored in hospitals. In rare situations, a significantly lowered oxygen level may trigger a cascade of events from which the body may not be able to recover, leading to SUDEP. In animal models, providing oxygen prior to seizures occurring has been shown to eliminate oxygen desaturation, but more importantly eliminate mortality in animals prone to death due to seizures.
Pre-oxygenation is a standard procedure during rapid-sequence induction anesthesia as it reduces the risk of oxygen desaturation during the apneic period of the procedure. On room air, the estimated duration of safe apnea is 1 minute, but this can increase to 8 minutes following pre-treatment with high FiO2 (Weingart and Levitan 2012). This is primarily due to oxygen replacing nitrogen within alveoli, creating a reservoir of oxygen within the lungs from which transfer to the bloodstream can continue despite the lack of ventilation. The apneic episode during seizures should benefit from the same principle.
The main purpose of the Epilepsy Monitoring Unit (EMU) is to evaluate patients to better characterize seizures, to identify the main seizure focus. In addition to standard EEG with electrodes on the scalp, some patients require invasive localization of the epileptic focus by surgically placing electrodes within the skull (often referred to as GRID patients) on or within the brain, with the goal of being able to resect the area that is causing seizures. To identify where seizure originate electrically, it requires that seizures occur during the vEEG procedure. To provoke seizures, medications are typically lowered, and both partial seizures and those with secondary generalization to full tonic-clonic (GTC) seizures will occur. Prior research has shows that oxygen desaturation below 90% occurs with some complex partial seizures, but hypoxia is more common and more profound with GTCs. Some centers use oxygen saturation and CO2 monitors as their standard of care, and at NYULMC the investigators also have the capability for both for clinical usage.
Oxygen is not currently a mandated standard-of-care, but is often provided by nasal prongs following seizures as part of the post-ictal nursing care, though there is no outcome data to support its use. It is unknown whether pre-treatment with oxygen will reduce the rate of oxygen desaturations clinically, as seen in animal models, and this is the goal of this research project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-oxygenation first | Experimental | Other: oxygen1. st, 3rd, 5th, etc seizure: continuous 'pre-oxygenation' up to 4L O2 nasal prongs, as tolerated 2. nd, 4th, 6th, etc seizure: Standard practice (O2 only in post-ictal period). |
| Standard practice first | Experimental | Other: oxygen1. st, 3rd, 5th, etc seizure: Standard practice (O2 only in post-ictal period). 2. nd, 4th, 6th, etc seizure: continuous 'pre-oxygenation' up to 4L O2 nasal prongs, as tolerated |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients aged 18-70 yo admitted for monitoring and capturing seizures at the EMU with scalp electrodes and for seizure localization with implantation of intracranial electrodes.
Key exclusion criteria (1 listed)
- patients who are considered healthy enough to provoke seizure activity will have few medical illnesses severe enough to be of concern with respect to continuous oxygen delivery. However, patients will be screened for moderate to severe chronic obstructive pulmonary disease and excluded, as their minute ventilation may decrease and CO2 levels increased with continuous oxygen supplementation.
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 |
|---|---|---|
| oxygenO2 by nasal prongs | Other | Pre-oxygenation first, Standard practice first |
Primary outcome
Oxygen desaturation below 92% following GTCs
Time frame: during and up to 6 minutes following the seizure
1 secondary outcome
Oxygen Desaturations below 80% following GTCs
Time frame: during and up to 6 minutes following seizures
Results and safety
The study was stopped early (reason given: Investigator is leaving the institution and has terminated the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oxygen in people with Epilepsy, run by NYU Langone Health 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 1 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: stopped early, as of the sponsor's last update on 13 Mar 2017. 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?
The study was stopped early (reason given: Investigator is leaving the institution and has terminated the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen desaturation below 92% following GTCs (time frame: during and up to 6 minutes following the seizure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2017.