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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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

Other trials in United States

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 groups in NCT02241798
Study groupRoleWhat they receive
Pre-oxygenation firstExperimental1. 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 firstExperimental1. 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.

  1. Oxygen desaturation below 92% following GTCs

    Measured: during and up to 6 minutes following the seizure

Secondary outcomes (1)
  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.

  1. First posted16 Sep 2014 (estimated)
  2. Study startAug 2013
  3. Primary completionAug 2014
  4. Study completionMar 2016

Why it stopped: Investigator is leaving the institution and has terminated the study.

Resources

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)
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

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.

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