Tumor of Pituitary and Suprasellar RegionNCT02105337
Tegaderm and Visual Evoked Potentials
An observational study of Tumor of Pituitary and Suprasellar Region, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The purpose of this study is to determine if a clear barrier placed over the eyes has any effect on goggle monitoring. When a patient has general anesthesia they lose the ability to blink and their eyes may dry. They may also lose the ability to keep their eyes fully closed. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tumor of Pituitary and Suprasellar Region
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Sep 2014
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: undergoing transsphenoidal pituitary tumor resection with visual evoked potential
Who may be able to join
- >18 years of age -
Who cannot join
- no history of diabetic retinopathy not currently pregnant
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study: Does Tegaderm Placement on Eyes to Prevent Lagophthalmos Affect Visual Evoked Potentials Data Latency and Amplitude
The purpose of this study is to determine if a clear barrier placed over the eyes has any effect on goggle monitoring. When a patient has general anesthesia they lose the ability to blink and their eyes may dry. They may also lose the ability to keep their eyes fully closed. The anesthesiologist takes several steps to prevent injury to the eyes. First the eyes will be lubricated with ointment and the eyelids will be held in a closed position by the use of a clear barrier. During pituitary surgery it is the routine practice to perform many types of monitoring. One type of monitoring is to stimulate your eyes with a light. This helps your surgeon protect the nerve supply to your eyes. The light is supplied by a pair of goggles placed over your eyes during surgery.
To help achieve our objective, the investigators are asking patients who are undergoing pituitary surgery to give us permission to record two sets of numbers form the monitoring device once prior to the application of the clear barrier and the second after the barrier is applied. This will be done when the patient is already asleep and will not be aware this is happening.
Read the detailed description
Corneal injury is the most frequent ocular complication during general anesthesia as the patient does not have the ability to blink or keep their eyes completely closed. Lagophthalmos is defined as the inability to close the eyelids completely. Blinking covers the eye with a thin layer of tear fluid, thereby promoting a moist environment necessary for the cells of the exterior part of the eye. The tears also flush out foreign bodies and wash them away. This is crucial to maintain lubrication and proper eye health. If this process is impaired, as in lagophthalmos, the eye can suffer abrasions and infections. Lagophthalmos leads to corneal drying and ulceration. Several strategies are widely used to try and prevent corneal abrasions, although there is a paucity of recent studies to support one method over another. If a patient is to receive general anesthesia the common practice is to lubricate the eyes and tape them closed.
One of the ways to prevent lagophthalmos is to use tegaderm. A tegaderm is a thin transparent barrier customarily used to protect wounds and catheter sites. The tegaderm has several advantages including breathability and conformity to skin. In the operating room it is place over the patients' eyelids to keep the eyes closed and prevent injury.
During surgical removal of a pituitary adenoma, conduction in the anterior visual pathways is monitored by continuous recording of visual evoked potentials (VEP). The VEP tests the function of the visual pathway from the retina to the occipital cortex. It measures the conduction of the visual pathways from the optic nerve, optic chiasm, and optic radiations to the occipital cortex. This method is performed by the application of special goggles over the eyes. These goggles placed over the tegaderm are noninvasive and have an embedded flashing diode for delivery of visual stimuli. Changes of the occipital EEG (as recorded intraoperatively on a computer program by a neurophysiology technician) can be observed under stimulation of light in attempt to localize structures or possible damage of those structures in the primary visual pathway. This is helpful to the neurosurgeon who aims to avoid compression and injury to the optic nerve.
These goggles have been used routinely over years for visual pathway monitoring during pituitary tumor resection. Nevertheless there is a question if the application of tegaderm affects VEP monitoring. By measuring visual evoked potentials before and after tegaderm placement, we hope to determine if there is a change in evoked potential data due to placement of tegaderm. On other words, we will be able to identify if tegaderm placement affects visual evoked potential data reliability.
Experimental Plan:
The investigators will approach all patients over the age of 18 undergoing transsphenoidal pituitary tumor resection with visual evoke potential monitoring.The plan is to include 40 patients here at University Hospital. If patients are agreeable all subjects will have their VEP measured before and after routine tegaderm application. Visual evoked potential monitoring will be conducted as routinely done by the neurophysiology technician. Data will be collected from neurophysiologist report and then analyzed for latency and amplitude before and after tegaderm application. As a matter of routine, the full monitoring report becomes a component of the patient's medical record.
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| tegaderm placement | all pts will have tegaderm placed prior to goggles for VEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in latency of VEP
Visual evoked potential data in terms of latency and amplitude will be compared before and after tegaderm placement and statistically analyzed. We expect to make pilot preliminary conclusion if tegaderm application affects visual evoked potential monitoring in term of latency and amplitude of the data.
Measured: 1 minute
Secondary outcomes (1)
Change in amplitude of VEP
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startJul 2013
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: PI leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor of Pituitary and Suprasellar RegionStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anesthesia, Rutgers, The State University of New Jersey
- Investigators
- Sergey Pisklakov, MD, Principal investigator, Rutgers/SUNJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105337
- Sponsor's protocol ID
- 2013002781
- Status last verified
- Sep 2014
- First submitted
- 15 Jan 2014
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: Does Tegaderm Placement on Eyes to Prevent Lagophthalmos Affect Visual Evoked Potentials Data Latency and Amplitude
- ClinicalTrials.gov ID
- NCT02105337
- Acronym / sponsor ID
- 2013002781
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI leaving institution
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 7 Apr 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 purpose of this study is to determine if a clear barrier placed over the eyes has any effect on goggle monitoring. When a patient has general anesthesia they lose the ability to blink and their eyes may dry. They may also lose the ability to keep their eyes fully closed. The anesthesiologist takes several steps to prevent injury to the eyes. First the eyes will be lubricated with ointment and the eyelids will be held in a closed position by the use of a clear barrier. During pituitary surgery it is the routine practice to perform many types of monitoring. One type of monitoring is to stimulate your eyes with a light. This helps your surgeon protect the nerve supply to your eyes. The light is supplied by a pair of goggles placed over your eyes during surgery.
To help achieve our objective, the investigators are asking patients who are undergoing pituitary surgery to give us permission to record two sets of numbers form the monitoring device once prior to the application of the clear barrier and the second after the barrier is applied. This will be done when the patient is already asleep and will not be aware this is happening.
Detailed description
Corneal injury is the most frequent ocular complication during general anesthesia as the patient does not have the ability to blink or keep their eyes completely closed. Lagophthalmos is defined as the inability to close the eyelids completely. Blinking covers the eye with a thin layer of tear fluid, thereby promoting a moist environment necessary for the cells of the exterior part of the eye. The tears also flush out foreign bodies and wash them away. This is crucial to maintain lubrication and proper eye health. If this process is impaired, as in lagophthalmos, the eye can suffer abrasions and infections. Lagophthalmos leads to corneal drying and ulceration. Several strategies are widely used to try and prevent corneal abrasions, although there is a paucity of recent studies to support one method over another. If a patient is to receive general anesthesia the common practice is to lubricate the eyes and tape them closed.
One of the ways to prevent lagophthalmos is to use tegaderm. A tegaderm is a thin transparent barrier customarily used to protect wounds and catheter sites. The tegaderm has several advantages including breathability and conformity to skin. In the operating room it is place over the patients' eyelids to keep the eyes closed and prevent injury.
During surgical removal of a pituitary adenoma, conduction in the anterior visual pathways is monitored by continuous recording of visual evoked potentials (VEP). The VEP tests the function of the visual pathway from the retina to the occipital cortex. It measures the conduction of the visual pathways from the optic nerve, optic chiasm, and optic radiations to the occipital cortex. This method is performed by the application of special goggles over the eyes. These goggles placed over the tegaderm are noninvasive and have an embedded flashing diode for delivery of visual stimuli. Changes of the occipital EEG (as recorded intraoperatively on a computer program by a neurophysiology technician) can be observed under stimulation of light in attempt to localize structures or possible damage of those structures in the primary visual pathway. This is helpful to the neurosurgeon who aims to avoid compression and injury to the optic nerve.
These goggles have been used routinely over years for visual pathway monitoring during pituitary tumor resection. Nevertheless there is a question if the application of tegaderm affects VEP monitoring. By measuring visual evoked potentials before and after tegaderm placement, we hope to determine if there is a change in evoked potential data due to placement of tegaderm. On other words, we will be able to identify if tegaderm placement affects visual evoked potential data reliability.
Experimental Plan:
The investigators will approach all patients over the age of 18 undergoing transsphenoidal pituitary tumor resection with visual evoke potential monitoring.The plan is to include 40 patients here at University Hospital. If patients are agreeable all subjects will have their VEP measured before and after routine tegaderm application. Visual evoked potential monitoring will be conducted as routinely done by the neurophysiology technician. Data will be collected from neurophysiologist report and then analyzed for latency and amplitude before and after tegaderm application. As a matter of routine, the full monitoring report becomes a component of the patient's medical record.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tegaderm placement | – | –all pts will have tegaderm placed prior to goggles for VEP |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- undergoing transsphenoidal pituitary tumor resection with visual evoked potential
Key inclusion criteria (1 listed)
- >18 years of age -
Key exclusion criteria (2 listed)
- no history of diabetic retinopathy not currently pregnant
- -
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
change in latency of VEP
Time frame: 1 minute
Visual evoked potential data in terms of latency and amplitude will be compared before and after tegaderm placement and statistically analyzed. We expect to make pilot preliminary conclusion if tegaderm application affects visual evoked potential monitoring in term of latency and amplitude of the data.
1 secondary outcome
Change in amplitude of VEP
Time frame: 1 minute
Results and safety
The study was stopped early (reason given: PI leaving institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
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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.
Sergey Pisklakov, MD principal investigator
Rutgers/SUNJ
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 Tumor of Pituitary and Suprasellar Region, run by Rutgers, The State University of New Jersey 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 2 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 11 Mar 2015. 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: PI leaving institution). 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?
change in latency of VEP (time frame: 1 minute). 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 11 Mar 2015.