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Pre-oxygenation and Measures of Gas Exchanges During Seizures in the Epilepsy Monitoring Unit

Primary Purpose

Epilepsy

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
oxygen
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring epilepsy, oxygen saturation, transcutaneous carbon dioxide, sudep, pre-oxygenation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • NYU Langone Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pre-oxygenation first

Standard practice first

Arm Description

st, 3rd, 5th, etc seizure: continuous 'pre-oxygenation' up to 4L O2 nasal prongs, as tolerated nd, 4th, 6th, etc seizure: Standard practice (O2 only in post-ictal period).

st, 3rd, 5th, etc seizure: Standard practice (O2 only in post-ictal period). nd, 4th, 6th, etc seizure: continuous 'pre-oxygenation' up to 4L O2 nasal prongs, as tolerated

Outcomes

Primary Outcome Measures

Oxygen desaturation below 92% following GTCs

Secondary Outcome Measures

Oxygen Desaturations below 80% following GTCs

Full Information

First Posted
September 12, 2014
Last Updated
March 10, 2017
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT02241798
Brief Title
Pre-oxygenation and Measures of Gas Exchanges During Seizures in the Epilepsy Monitoring Unit
Official Title
Effects of Pre-oxygenation on Indicators of Gas Exchange and Autonomic Function During Seizures in the Epilepsy Unit
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Investigator is leaving the institution and has terminated the study.
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
epilepsy, oxygen saturation, transcutaneous carbon dioxide, sudep, pre-oxygenation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-oxygenation first
Arm Type
Experimental
Arm Description
st, 3rd, 5th, etc seizure: continuous 'pre-oxygenation' up to 4L O2 nasal prongs, as tolerated nd, 4th, 6th, etc seizure: Standard practice (O2 only in post-ictal period).
Arm Title
Standard practice first
Arm Type
Experimental
Arm Description
st, 3rd, 5th, etc seizure: Standard practice (O2 only in post-ictal period). nd, 4th, 6th, etc seizure: continuous 'pre-oxygenation' up to 4L O2 nasal prongs, as tolerated
Intervention Type
Other
Intervention Name(s)
oxygen
Intervention Description
O2 by nasal prongs
Primary Outcome Measure Information:
Title
Oxygen desaturation below 92% following GTCs
Time Frame
during and up to 6 minutes following the seizure
Secondary Outcome Measure Information:
Title
Oxygen Desaturations below 80% following GTCs
Time Frame
during and up to 6 minutes following seizures

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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Pre-oxygenation and Measures of Gas Exchanges During Seizures in the Epilepsy Monitoring Unit

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