ShouldersurgeryNCT01225185
Assessing Cerebral Blood Flow Autoregulation During Surgery in the Head-up Position
An observational study of Shouldersurgery, run by Johns Hopkins University at 1 site in United States.
Trial summary
Neurological injury after elective shoulder surgery in the beach chair position is thought to result from cerebral hypoperfusion and should therefore be preventable by appropriate hemodynamic monitoring and management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shouldersurgery
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Apr 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 120 patients undergoing shoulder surgery in the supine lateral position and 120 subjects undergoing surgery in the beach chair position.
Who may be able to join
- Patients 18 years old or older undergoing shoulder arthroscopy in the beach chair position or lateral decubitus position without elevation of the head.
Who cannot join
- Women of child bearing potential require a negative urine HCG test to be enrolled. Patients unable to attend postoperative cognitive testing sessions will be excluded from the study as will those with known allergy to adhesive tape.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
Official title: Assessing Cerebral Blood Flow Autoregulation in the Head-up Versus Supine Position During General Anesthesia and Its Relationship With Postoperative Neurocognitive Changes and Serum Biomarkers of Brain Injury
Neurological injury after elective shoulder surgery in the beach chair position is thought to result from cerebral hypoperfusion and should therefore be preventable by appropriate hemodynamic monitoring and management. This proposal will use a system to continuously monitor cerebral blood flow autoregulation to identify safe arterial blood pressure targets in patients in the beach chair position, compared with a control cohort having orthopedic surgery in the lateral decubitus supine position. Autoregulation data will be compared against a new, highly specific and sensitive serum biomarker of neurologic injury, glial fibrillary acid protein, and postoperative neurocognitive testing results.
Read the detailed description
Neurologic injury under general anesthesia in the beach chair position is believed to result from cerebral hypoperfusion.1 We hypothesize that brain hypoperfusion in this circumstance is caused by blood pressure monitoring that does not reflect of cerebral perfusion pressure. Maintenance of arterial blood pressure above an individual's lower limit of cerebral blood flow autoregulation would prevent this devastating complication. Near infrared spectroscopy can be used to continuously monitor autoregulation with the cerebral oximetry index (COx), a moving linear correlation coefficient between cortical tissue oxygen saturation and arterial pressure. We hypothesize that subjects in the beach chair position have impaired cerebral blood flow autoregulation compared with subjects undergoing surgery in the lateral decubitus supine position. We will test this hypothesis by comparing CBF autoregulation data, including the percentage of time patients undergoing elective surgery have abnormal autoregulation, in the beach chair position versus supine position. We will establish the range of arterial pressure required to maintain autoregulation in the two groups. Cerebral autoregulation results will be assessed for a relationship with postoperative neurocognitive dysfunction and with serum glial fibrillary acid protein levels, a biomarker of brain injury.
The specific aims of this study are:
- To compare the average cerebral oximetry index and the percentage of time with abnormal COx between subjects in the head up or supine position during surgery under general anesthesia.
- To compare the range of arterial blood pressure required for a normal cerebral oximetry index between subjects anesthetized in the head up or supine position.
- To assess the association between impaired cerebral blood flow autoregulation and postoperative neurocognitive decline 1 month after surgery and perioperative elevation of serum glial fibrillary acid protein.
Monitoring autoregulation non-invasively with COx has the potential to improve patient safety by delineating individualized limits of safe ABP for patients at risk of neurologic injury.
- Conditions
- Shouldersurgery
- Keywords
- neurological complications, brain blood flow autoregulation
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 |
|---|---|---|
| Patients undergoing shoulder surgery | This observational study will compare cerebral blood flow autoregulation in patients undergoing surgery in either the supine lateral position or the semi-recumbent or "beach chair" position. The choice of patient positioning is not randomized but based on usual surgical considerations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral oximetry index between subjects in the head up or supine position during surgery under general anesthesia
Measured: During surgery
Secondary outcomes (2)
To compare the range of arterial blood pressure required for a normal cerebral oximetry index between subjects anesthetized in the head up or supine position.
Measured: During surgery
To assess the association between impaired cerebral blood flow autoregulation and postoperative neurocognitive decline and elevation of serum glial fibrillary acid protein.
Measured: 1 month after surgery for neurocognitive decline; perioperatively for serum GFAP levels.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShouldersurgeryStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Anesthesia Patient Safety Foundation
- Responsible party
- Sponsor
- Investigators
- Charles W Hogue, MD, Principal investigator, The Johns Hopkins Medical Institutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225185
- Sponsor's protocol ID
- APSF
- Other IDs
- 1R01HL092259
- Status last verified
- Aug 2017
- First submitted
- 18 Oct 2010
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Cerebral Blood Flow Autoregulation in the Head-up Versus Supine Position During General Anesthesia and Its Relationship With Postoperative Neurocognitive Changes and Serum Biomarkers of Brain Injury
- ClinicalTrials.gov ID
- NCT01225185
- Acronym / sponsor ID
- APSF
- Conditions
- Shouldersurgery
- Keywords
- neurological complications, brain blood flow autoregulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Anesthesia Patient Safety Foundation
- Study start
- Jul 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 20 Oct 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.
Neurological injury after elective shoulder surgery in the beach chair position is thought to result from cerebral hypoperfusion and should therefore be preventable by appropriate hemodynamic monitoring and management. This proposal will use a system to continuously monitor cerebral blood flow autoregulation to identify safe arterial blood pressure targets in patients in the beach chair position, compared with a control cohort having orthopedic surgery in the lateral decubitus supine position. Autoregulation data will be compared against a new, highly specific and sensitive serum biomarker of neurologic injury, glial fibrillary acid protein, and postoperative neurocognitive testing results.
Detailed description
Neurologic injury under general anesthesia in the beach chair position is believed to result from cerebral hypoperfusion.1 We hypothesize that brain hypoperfusion in this circumstance is caused by blood pressure monitoring that does not reflect of cerebral perfusion pressure. Maintenance of arterial blood pressure above an individual's lower limit of cerebral blood flow autoregulation would prevent this devastating complication. Near infrared spectroscopy can be used to continuously monitor autoregulation with the cerebral oximetry index (COx), a moving linear correlation coefficient between cortical tissue oxygen saturation and arterial pressure. We hypothesize that subjects in the beach chair position have impaired cerebral blood flow autoregulation compared with subjects undergoing surgery in the lateral decubitus supine position. We will test this hypothesis by comparing CBF autoregulation data, including the percentage of time patients undergoing elective surgery have abnormal autoregulation, in the beach chair position versus supine position. We will establish the range of arterial pressure required to maintain autoregulation in the two groups. Cerebral autoregulation results will be assessed for a relationship with postoperative neurocognitive dysfunction and with serum glial fibrillary acid protein levels, a biomarker of brain injury.
The specific aims of this study are:
- To compare the average cerebral oximetry index and the percentage of time with abnormal COx between subjects in the head up or supine position during surgery under general anesthesia.
- To compare the range of arterial blood pressure required for a normal cerebral oximetry index between subjects anesthetized in the head up or supine position.
- To assess the association between impaired cerebral blood flow autoregulation and postoperative neurocognitive decline 1 month after surgery and perioperative elevation of serum glial fibrillary acid protein.
Monitoring autoregulation non-invasively with COx has the potential to improve patient safety by delineating individualized limits of safe ABP for patients at risk of neurologic injury.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing shoulder surgery | – | –This observational study will compare cerebral blood flow autoregulation in patients undergoing surgery in either the supine lateral position or the semi-recumbent or "beach chair" position. The choice of patient positioning is not randomized but based on usual surgical considerations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 120 patients undergoing shoulder surgery in the supine lateral position and 120 subjects undergoing surgery in the beach chair position.
Key inclusion criteria (1 listed)
- Patients 18 years old or older undergoing shoulder arthroscopy in the beach chair position or lateral decubitus position without elevation of the head.
Key exclusion criteria (1 listed)
- Women of child bearing potential require a negative urine HCG test to be enrolled. Patients unable to attend postoperative cognitive testing sessions will be excluded from the study as will those with known allergy to adhesive tape.
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
cerebral oximetry index between subjects in the head up or supine position during surgery under general anesthesia
Time frame: During surgery
2 secondary outcomes
To compare the range of arterial blood pressure required for a normal cerebral oximetry index between subjects anesthetized in the head up or supine position.
Time frame: During surgery
To assess the association between impaired cerebral blood flow autoregulation and postoperative neurocognitive decline and elevation of serum glial fibrillary acid protein.
Time frame: 1 month after surgery for neurocognitive decline; perioperatively for serum GFAP levels.
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 22 Aug 2017.
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.
Charles W Hogue, MD principal investigator
The Johns Hopkins Medical Institutions
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 Shouldersurgery, run by Johns Hopkins 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 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: finished, as of the sponsor's last update on 22 Aug 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 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?
cerebral oximetry index between subjects in the head up or supine position during surgery under general anesthesia (time frame: During surgery). 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 22 Aug 2017.