Injury as a Result of Positioning
Conditions
Keywords
orthopedic procedures
Brief summary
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.
Detailed description
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.
Interventions
DEVICENIRS
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
DEVICENIRS monitored not treated
Near infrared spectroscopy (NIRS) monitored but anesthesiologist blinded to NIRS information and treatment is standard of care.
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* at least 18 years of age * elective shoulder surgery in the beach chair position
Exclusion criteria
* less than 18 years of age * preoperative score of 23 or less on the pre-operative Mini Mental State Exam * traumatic brain injury * transient ischemic attack * cerebrovascular incident * any apparent clinical neurologic dysfunction * carotid artery stenosis * known vascular malformation in head * inability to have blood pressure measured in the opposite extremity * malignant hyperthermia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With 20+% Cerebral Desaturation Events | one day | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mini Mental State Exam (MMSE) > 2 or a Score of 23 up to Two Weeks After Surgery Minus Baseline Value | baseline and up to two weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 47 |
| 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 NIRS monitoring and per standard of care. | 43 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 3 |
| Overall Study | NIRS not recording | 1 | 0 |
| Overall Study | participant difficulty breathing | 1 | 0 |
Baseline characteristics
| Characteristic | NIRS Monitored Not Treated | NIRS Monitored and Treated | Total |
|---|---|---|---|
| Age, Customized >=18 years | 47 participants | 43 participants | 90 participants |
| Region of Enrollment United States | 47 participants | 43 participants | 90 participants |
| Sex: Female, Male Female | 16 Participants | 14 Participants | 30 Participants |
| Sex: Female, Male Male | 31 Participants | 29 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 47 | 0 / 43 |
| serious Total, serious adverse events | 0 / 47 | 0 / 43 |
Outcome results
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
Time frame: one day
Population: Participants undergoing elective shoulder surgery in the beach chair position at West Virginia University Medicine Hospital.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NIRS Monitored Not Treated | Percentage of Participants With 20+% Cerebral Desaturation Events | 40 Participants |
| NIRS Monitored and Treated | Percentage of Participants With 20+% Cerebral Desaturation Events | 40 Participants |
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.
Time frame: baseline and up to two weeks
Population: Participants who underwent elective shoulder surgery in the beach chair position at West Virginia University Medicine Hospital.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NIRS Monitored Not Treated | Change in Mini Mental State Exam (MMSE) > 2 or a Score of 23 up to Two Weeks After Surgery Minus Baseline Value | -1.33 scores on a scale | Standard Error 0.82 |
| NIRS Monitored and Treated | Change in Mini Mental State Exam (MMSE) > 2 or a Score of 23 up to Two Weeks After Surgery Minus Baseline Value | -.17 scores on a scale | Standard Error 0.16 |
p-value: 0.16595% CI: [-0.49, 2.82]ANOVA