NeuropraxiaNCT02532582
Assessment of Patient Positioning
An observational study of Neuropraxia, run by Northwestern University.
Trial summary
The purpose of this study is to ultimately prevent injuries to nerves during surgical procedures. Living donor liver transplant or hepatectomy (removal of a piece of the liver) patients will receive an arterial line as standard of care. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropraxia
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2015to May 2020
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All adult living liver donors and liver surgery patients at Northwestern Memorial Hospital (surgical setup is similar for living liver donor surgery and liver surgery (e.g. retractors, arterial line for monitoring, surgeons). Investigators will approach both living liver donors and liver surgery patients for enrollment to receive additional neuromuscular monitoring.
Who may be able to join
- All adult living liver donors and liver surgery patients at Northwestern Memorial Hospital (surgical setup is similar for living liver donor surgery and liver surgery (e.g. retractors, arterial line for monitoring, surgeons). Investigators will approach both living liver donors and liver surgery patients for enrollment to receive additional neuromuscular monitoring.
- All subjects must have given signed, informed consent prior to registration on the study.
Who cannot join
- Anyone not meeting the inclusion criteria.
About this study
Official title: Effort to Reduce Postoperative Brachial Neuropraxia Through Nerve Compression
The purpose of this study is to ultimately prevent injuries to nerves during surgical procedures. Living donor liver transplant or hepatectomy (removal of a piece of the liver) patients will receive an arterial line as standard of care. The arterial line helps monitor blood pressure along with the compression of important vessels during surgery. In addition, research participants will undergo neuromuscular monitoring using Somato-Sensory Evoked Potential (SSEP) or Evoked Potential Assessment Device (EPAD). During an operation, neuromuscular monitoring can tell doctors if the nerves being studied are working normally or if they are at risk for injury. This study will help investigators to understand what kind of monitoring is best to prevent nerve injuries during a surgical procedure.
Read the detailed description
As standard of care, research participants undergoing a living donor liver transplant or other liver surgeries will receive a right-sided radial arterial line to monitor his/her blood pressure along with the compression of important vessels during surgery. These measurements will be captured throughout the surgical procedure. If blunting of the arterial line wave form occurs, the anesthesiology team alerts the surgical team to release the retractors until the wave form returns to baseline. Depression of the radial arterial line wave form will be captured, time-stamped, and stored by the research transplant anesthesiology team.
Additionally as part of research, participants will receive neuromuscular monitoring using SSEP or EPAD to measure their nerve signals during the surgery (3-6 hours). SSEP or EPAD measurements will occur at the median and ulnar nerve and will be captured throughout the surgical procedure. The research neuromonitoring team will consists of highly skilled technicians, who monitor patients during neurosurgical and orthopedic surgeries. SSEP or EPAD output captured during the surgery will be time-stamped, stored, and interpreted by a Neurologist. To investigate if a correlation exists, SSEP or EPAD abnormalities will be correlated and analyzed with the arterial wave form depressions.
To determine whether a correlation exists with clinical outcomes, a prospective medical record review will be conducted. Before performing the prospective medical record review, authorized research personnel will obtain informed consent from each participant.
- Conditions
- Neuropraxia
- Keywords
- nerve compression
- Medical subject headings
- Neuroma
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 |
|---|---|---|
| Living Liver Donor Transplant Donors | All adult living liver donors and liver surgery patients at Northwestern Memorial Hospital (same surgical setup is used for living liver donor surgery and liver surgery (e.g. retractors, arterial line for monitoring, surgeons). Living liver donors and liver surgery patients for enrollment to receive neuromuscular monitoring) |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change in arterial line wave form and a change in the neuromuscular signal using SSEP or EPAD will be measured and tested with the Pearson correlation coefficient as well as nonparametric Spearman's rank correlation coefficient.
To establish the correlation between the wave form of the arterial line readings and neuromuscular monitoring.
Measured: 12 mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuropraxiaStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Ladner, Northwestern University
- Investigators
- Daniela P Ladner, MD, MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532582
- Sponsor's protocol ID
- STU00105002
- Status last verified
- Apr 2021
- First submitted
- 10 Aug 2015
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effort to Reduce Postoperative Brachial Neuropraxia Through Nerve Compression
- ClinicalTrials.gov ID
- NCT02532582
- Acronym / sponsor ID
- STU00105002
- Conditions
- Neuropraxia
- Keywords
- nerve compression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 26 Aug 2015 (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 ultimately prevent injuries to nerves during surgical procedures. Living donor liver transplant or hepatectomy (removal of a piece of the liver) patients will receive an arterial line as standard of care. The arterial line helps monitor blood pressure along with the compression of important vessels during surgery. In addition, research participants will undergo neuromuscular monitoring using Somato-Sensory Evoked Potential (SSEP) or Evoked Potential Assessment Device (EPAD). During an operation, neuromuscular monitoring can tell doctors if the nerves being studied are working normally or if they are at risk for injury. This study will help investigators to understand what kind of monitoring is best to prevent nerve injuries during a surgical procedure.
Detailed description
As standard of care, research participants undergoing a living donor liver transplant or other liver surgeries will receive a right-sided radial arterial line to monitor his/her blood pressure along with the compression of important vessels during surgery. These measurements will be captured throughout the surgical procedure. If blunting of the arterial line wave form occurs, the anesthesiology team alerts the surgical team to release the retractors until the wave form returns to baseline. Depression of the radial arterial line wave form will be captured, time-stamped, and stored by the research transplant anesthesiology team.
Additionally as part of research, participants will receive neuromuscular monitoring using SSEP or EPAD to measure their nerve signals during the surgery (3-6 hours). SSEP or EPAD measurements will occur at the median and ulnar nerve and will be captured throughout the surgical procedure. The research neuromonitoring team will consists of highly skilled technicians, who monitor patients during neurosurgical and orthopedic surgeries. SSEP or EPAD output captured during the surgery will be time-stamped, stored, and interpreted by a Neurologist. To investigate if a correlation exists, SSEP or EPAD abnormalities will be correlated and analyzed with the arterial wave form depressions.
To determine whether a correlation exists with clinical outcomes, a prospective medical record review will be conducted. Before performing the prospective medical record review, authorized research personnel will obtain informed consent from each participant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Living Liver Donor Transplant Donors | – | –All adult living liver donors and liver surgery patients at Northwestern Memorial Hospital (same surgical setup is used for living liver donor surgery and liver surgery (e.g. retractors, arterial line for monitoring, surgeons). Living liver donors and liver surgery patients for enrollment to receive neuromuscular monitoring) |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adult living liver donors and liver surgery patients at Northwestern Memorial Hospital (surgical setup is similar for living liver donor surgery and liver surgery (e.g. retractors, arterial line for monitoring, surgeons). Investigators will approach both living liver donors and liver surgery patients for enrollment to receive additional neuromuscular monitoring.
Key inclusion criteria (2 listed)
- All adult living liver donors and liver surgery patients at Northwestern Memorial Hospital (surgical setup is similar for living liver donor surgery and liver surgery (e.g. retractors, arterial line for monitoring, surgeons). Investigators will approach both living liver donors and liver surgery patients for enrollment to receive additional neuromuscular monitoring.
- All subjects must have given signed, informed consent prior to registration on the study.
Key exclusion criteria (1 listed)
- Anyone not meeting the inclusion criteria.
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
A change in arterial line wave form and a change in the neuromuscular signal using SSEP or EPAD will be measured and tested with the Pearson correlation coefficient as well as nonparametric Spearman's rank correlation coefficient.
Time frame: 12 mos
To establish the correlation between the wave form of the arterial line readings and neuromuscular monitoring.
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 6 Apr 2021.
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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.
Daniela P Ladner, MD, MPH principal investigator
Northwestern University
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropraxia, run by Northwestern University.
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 2 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: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
A change in arterial line wave form and a change in the neuromuscular signal using SSEP or EPAD will be measured and tested with the Pearson correlation coefficient as well as nonparametric Spearman's rank correlation coefficient. (time frame: 12 mos). 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 6 Apr 2021.