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The purpose of this study was to use Near Infrared Spectroscopy (NIRS) monitoring on participants undergoing shoulder surgery in the beach chair position (BCP) to determine cerebral desaturation events (CDE) and to further determine cognitive changes pre and post surgery using the Mini Mental State Exam.
In this prospective, randomized, controlled study, investigators used a standardized anesthesia protocol to maintain the Mean Arterial Pressure (MAP) during surgeries done in the Beach Chair Position (BCP). Investigators hypothesized that, if the MAP was maintained, Near Infrared Spectroscopy (NIRS) monitoring would not change intra-operative anesthesia management and would not affect the post-operative cognitive outcomes of participants undergoing surgery in the beach chair position. Investigators secondarily wanted to document the actual incidence of cerebral desaturation events (CDEs) recorded by NIRS occurring in participants placed in the BCP if the MAP was strictly maintained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIRS Monitored Not Treated | Active Comparator | Anesthesiologist blinded to Near Infrared Spectroscopy (NIRS) |
|
| NIRS Monitored and Treated | Active Comparator | Anesthesiologist treats based on Near Infrared Spectroscopy (NIRS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIRS | Device | Near infrared spectroscopy (NIRS) monitor allows anesthesiologist to treat cerebral desaturations according to NIRS results while maintaining Mean Arterial Pressure (MAP) at least 60mmHG or at least 80% of baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 20+% Cerebral Desaturation Events | Cerebral desaturation event defined as a 20% or greater decrease from baseline Mean Arterial Pressure, while undergoing elective ambulatory surgery in the beach chair position | one day |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mini Mental State Exam (MMSE) > 2 or a Score of 23 up to Two Weeks After Surgery Minus Baseline Value | Change in total score of the MMSE measurement taken at baseline before surgery compared to the follow up measurement taken up to two weeks after surgery. Total range is zero to 30 with higher values indicating a better outcome. Indicator of cognitive decline measured by a change in Mini Mental State Exam (MMSE) > 2 or a score of 23 for two time points; up to two weeks after surgery minus the baseline value. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George K Bal, MD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University | Morgantown | West Virginia | 26506-9196 | United States |
Only group data will be available.
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Excluded reasons: anesthesiologist availability; surgery started early; illiteracy; less than 24 on the pre-operative MMSE; supine and BCP; no surgery; surgery delayed; operating suite could not accommodate NIRS monitor; data not recorded; previous difficult intubation; surgeon in two operating suites simultaneously; not needed, quota met.
Participants were informed of the study in the Orthopaedic clinic at the visit prior to surgery. The consent form and pre- and post-testing using the Mini Mental State Examination (MMSE) was reviewed. Following consent, the baseline MMSE was administered. A score below 24 disqualified participants. Recruitment began October 2012 and ended May 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | NIRS Monitored Not Treated | Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists were blinded to the NIRS data and treated participants based on standard of care treatment. |
| FG001 | NIRS Monitored and Treated | Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists treated participants based on the NIRS monitoring in addition to standard of care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NIRS Monitored Not Treated | Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists were blinded to NIRS data and treated participants per standard of care. |
| BG001 | NIRS Monitored and Treated |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | >=18 years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With 20+% Cerebral Desaturation Events | Cerebral desaturation event defined as a 20% or greater decrease from baseline Mean Arterial Pressure, while undergoing elective ambulatory surgery in the beach chair position | Participants undergoing elective shoulder surgery in the beach chair position at West Virginia University Medicine Hospital. | Posted | Count of Participants | Participants | one day |
|
1 day
Shoulder surgeries done as same-day surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NIRS Monitored Not Treated | Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists were blinded to the NIRS data and treated participants based on standard of care treatment. |
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It is difficult to generalize the results of the study, few CDEs, to similar populations. Intubation may be related to the occurrence of CDEs or may have been related to patient co-morbidities and not the actual intubation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. George K Bal | West Virginia University Department of Orthopaedics | 304-293-1310 | gbal@hsc.wvu.edu |
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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
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|
| NIRS monitored not treated | Device | Near infrared spectroscopy (NIRS) monitored but anesthesiologist blinded to NIRS information and treatment is standard of care. |
|
|
| baseline and up to two weeks |
| NIRS not recording |
|
Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists treated participants based NIRS monitoring and per standard of care. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| NIRS Monitored and Treated |
Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists treated participants based on NIRS monitoring results in addition to standard of care treatment based on MAP. |
|
|
| Secondary | Change in Mini Mental State Exam (MMSE) > 2 or a Score of 23 up to Two Weeks After Surgery Minus Baseline Value | Change in total score of the MMSE measurement taken at baseline before surgery compared to the follow up measurement taken up to two weeks after surgery. Total range is zero to 30 with higher values indicating a better outcome. Indicator of cognitive decline measured by a change in Mini Mental State Exam (MMSE) > 2 or a score of 23 for two time points; up to two weeks after surgery minus the baseline value. | Participants who underwent elective shoulder surgery in the beach chair position at West Virginia University Medicine Hospital. | Posted | Mean | Standard Error | scores on a scale | baseline and up to two weeks | participants | participants |
|
|
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | NIRS Monitored and Treated | Participants were monitored via near infrared spectroscopy (NIRS) for cerebral desaturation events during shoulder surgery in the beach chair position. Anesthesiologists treated participants based on the NIRS monitoring in addition to standard of care. | 0 | 43 | 0 | 43 |
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| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |