Trial Outcomes & Findings for Prospective Evaluation of Cognitive Outcomes After Anesthesia on Patients in the Beach Chair Position (NCT NCT02674334)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

90 participants

Primary outcome timeframe

one day

Results posted on

2017-09-11

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	47	43
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	5	3
Overall Study participant difficulty breathing	1	0
Overall Study NIRS not recording	1	0

Baseline Characteristics

Prospective Evaluation of Cognitive Outcomes After Anesthesia on Patients in the Beach Chair Position

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NIRS Monitored Not Treated n=47 Participants 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.	NIRS Monitored and Treated n=43 Participants 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.	Total n=90 Participants Total of all reporting groups
Age, Customized >=18 years	47 participants n=5 Participants	43 participants n=7 Participants	90 participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	29 Participants n=7 Participants	60 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants	43 participants n=7 Participants	90 participants n=5 Participants

PRIMARY outcome

Timeframe: one day

Population: Participants undergoing elective shoulder surgery in the beach chair position at West Virginia University Medicine Hospital.

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

Outcome measures

Outcome measures
Measure	NIRS Monitored Not Treated n=40 Participants 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 monitoring and treated participants per standard of care based on MAP.	NIRS Monitored and Treated n=40 Participants 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.
Percentage of Participants With 20+% Cerebral Desaturation Events	40 Participants	40 Participants

SECONDARY outcome

Timeframe: baseline and up to two weeks

Population: Participants who underwent elective shoulder surgery in the beach chair position at West Virginia University Medicine Hospital.

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.

Outcome measures

Outcome measures
Measure	NIRS Monitored Not Treated n=40 Participants 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 monitoring and treated participants per standard of care based on MAP.	NIRS Monitored and Treated n=40 Participants 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.
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 .82	-.17 scores on a scale Standard Error .16

Adverse Events

NIRS Monitored Not Treated

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NIRS Monitored and Treated

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. George K Bal

West Virginia University Department of Orthopaedics

Phone: 304-293-1310

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place