CraniotomyNCT01256749
A Comparative Study of Global 12 Lead Electroencephalogram to Frontal SedlineTM Electroencephalogram
An observational study of Craniotomy and Transphenoidal Pituitary Resection, run by Loma Linda University at 1 site in United States.
Trial summary
The fundamental reason for comparing the ability of the Frontal Sedline TM Electroencephalogram (PSA EEG) to standard Global 12 Lead Electroencephalogram (EEG) for burst suppression detection is to determine if a less expensive, less invasive and possibly more convenient bifrontal EEG monitor can be effective for… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Craniotomy, Transphenoidal Pituitary Resection
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Nov 2013
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for elective craniotomy or transphenoidal pituitary resection at LLUMC University Hospital in which the surgeon has requested intraoperative burst suppression therapy regardless of the inciting etiology will be eligible to participate in this study.
Who may be able to join
- Adult ASA class 1-3 male or female 18-90 years of age;
- scheduled for elective craniotomy in the LLUMC University Hospital, for which the surgeon has requested intraoperative burst suppression therapy;
- capable of understanding and signing informed consent;
- willing to have dual EEG monitoring.
Who cannot join
- Age under 18 years;
- emergency or trauma situation requiring craniotomy;
- surgical approach that prohibits placing the SEDLineTM array on the forehead;
- known sensitivity to the adhesives on the SEDLineTM array;
- lack of availability of standard EEG monitoring;
- patients with seizure disorders and refusal of consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Global 12 Lead Electroencephalogram to Frontal SedlineTM Electroencephalogram Monitoring for the Evaluation of Intraoperative Burst Suppression During Elective Craniotomy or Transphenoidal Pituitary Resection
The fundamental reason for comparing the ability of the Frontal Sedline TM Electroencephalogram (PSA EEG) to standard Global 12 Lead Electroencephalogram (EEG) for burst suppression detection is to determine if a less expensive, less invasive and possibly more convenient bifrontal EEG monitor can be effective for evaluation of anesthesia-induced intraoperative burst suppression therapy (IBST) for cerebral protection.
- Conditions
- Craniotomy, Transphenoidal Pituitary Resection
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between 4 channel PSA EEG and a global 12 lead EEG
The primary outcome measure is correlation between 4 channel frontal PSA EEG pattern and standard global 12 lead EEG during IBST.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniotomyStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah McIvor, MD, Loma Linda University
- Investigators
- Deborah W McIvor, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256749
- Sponsor's protocol ID
- 5100294
- Status last verified
- Sep 2014
- First submitted
- 2 Dec 2010
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Global 12 Lead Electroencephalogram to Frontal SedlineTM Electroencephalogram Monitoring for the Evaluation of Intraoperative Burst Suppression During Elective Craniotomy or Transphenoidal Pituitary Resection
- ClinicalTrials.gov ID
- NCT01256749
- Acronym / sponsor ID
- 5100294
- Conditions
- Craniotomy, Transphenoidal Pituitary Resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 9 Dec 2010 (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 fundamental reason for comparing the ability of the Frontal Sedline TM Electroencephalogram (PSA EEG) to standard Global 12 Lead Electroencephalogram (EEG) for burst suppression detection is to determine if a less expensive, less invasive and possibly more convenient bifrontal EEG monitor can be effective for evaluation of anesthesia-induced intraoperative burst suppression therapy (IBST) for cerebral protection.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for elective craniotomy or transphenoidal pituitary resection at LLUMC University Hospital in which the surgeon has requested intraoperative burst suppression therapy regardless of the inciting etiology will be eligible to participate in this study.
Key inclusion criteria (4 listed)
- Adult ASA class 1-3 male or female 18-90 years of age;
- scheduled for elective craniotomy in the LLUMC University Hospital, for which the surgeon has requested intraoperative burst suppression therapy;
- capable of understanding and signing informed consent;
- willing to have dual EEG monitoring.
Key exclusion criteria (6 listed)
- Age under 18 years;
- emergency or trauma situation requiring craniotomy;
- surgical approach that prohibits placing the SEDLineTM array on the forehead;
- known sensitivity to the adhesives on the SEDLineTM array;
- lack of availability of standard EEG monitoring;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between 4 channel PSA EEG and a global 12 lead EEG
Time frame: 24 hours
The primary outcome measure is correlation between 4 channel frontal PSA EEG pattern and standard global 12 lead EEG during IBST.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2014.
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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.
Deborah W McIvor, MD principal investigator
Loma Linda University
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 Craniotomy and Transphenoidal Pituitary Resection, run by Loma Linda University 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 9 Sep 2014. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation between 4 channel PSA EEG and a global 12 lead EEG (time frame: 24 hours). 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 9 Sep 2014.