Trial Outcomes & Findings for Optimizing Cerebral Autoregulation During Surgery (NCT NCT05308290)
NCT ID: NCT05308290
Last Updated: 2025-09-02
Results Overview
Extent (mmHg \* hours) of mean arterial pressure outside limits of cerebral autoregulation after establishment of target mean arterial pressure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
Intraoperative, up to 5 hours
Results posted on
2025-09-02
Participant Flow
2 patients were excluded during secondary screen before randomization
Participant milestones
| Measure |
Blood Pressure Managed by Cerebral Autoregulation
In this arm cerebral autoregulation monitoring will be used to determine the lower and upper limits of cerebral autoregulation. Monitoring will continue throughout the surgery. Blood pressure management will be maintained to be within the limits of cerebral autoregulation.
|
Standard of Care Blood Pressure Management
In this arm cerebral autoregulation monitoring will be used for observation. The anesthesia provider will use usual care guidelines for blood pressure management.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
7
|
|
Overall Study
COMPLETED
|
15
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Blood Pressure Managed by Cerebral Autoregulation
In this arm cerebral autoregulation monitoring will be used to determine the lower and upper limits of cerebral autoregulation. Monitoring will continue throughout the surgery. Blood pressure management will be maintained to be within the limits of cerebral autoregulation.
|
Standard of Care Blood Pressure Management
In this arm cerebral autoregulation monitoring will be used for observation. The anesthesia provider will use usual care guidelines for blood pressure management.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
still in study followup
|
0
|
1
|
Baseline Characteristics
Optimizing Cerebral Autoregulation During Surgery
Baseline characteristics by cohort
| Measure |
Blood Pressure Managed by Cerebral Autoregulation
n=18 Participants
In this arm cerebral autoregulation monitoring will be used to determine the lower and upper limits of cerebral autoregulation. Monitoring will continue throughout the surgery. Blood pressure management will be maintained to be within the limits of cerebral autoregulation.
|
Standard of Care Blood Pressure Management
n=7 Participants
In this arm cerebral autoregulation monitoring will be used for observation. The anesthesia provider will use usual care guidelines for blood pressure management.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.2 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
71.6 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
70.6 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Chronic Obstructive Pulmonary Disorder (COPD)
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Diabetes Mellitus
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Coronary Artery Disease
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Cardiac Arrhythmia
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Past Stroke or Transient Ischemic Attack
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Hypertension
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Hemoglobin (g/dl)
|
13.2 (g/dl)
STANDARD_DEVIATION 1.6 • n=5 Participants
|
13.7 (g/dl)
STANDARD_DEVIATION 0.7 • n=7 Participants
|
13.3 (g/dl)
STANDARD_DEVIATION 1.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Intraoperative, up to 5 hoursPopulation: Signals did not work with one participant and no data was collected.
Extent (mmHg \* hours) of mean arterial pressure outside limits of cerebral autoregulation after establishment of target mean arterial pressure.
Outcome measures
| Measure |
Blood Pressure Managed by Cerebral Autoregulation
n=17 Participants
In this arm cerebral autoregulation monitoring will be used to determine the lower and upper limits of cerebral autoregulation. Monitoring will continue throughout the surgery. Blood pressure management will be maintained to be within the limits of cerebral autoregulation.
|
Standard of Care Blood Pressure Management
n=7 Participants
In this arm cerebral autoregulation monitoring will be used for observation. The anesthesia provider will use usual care guidelines for blood pressure management.
|
|---|---|---|
|
Mean Arterial Pressure Outside Limits of Cerebral Autoregulation
|
2.2 mmHg * hours
Standard Deviation 2.1
|
1.8 mmHg * hours
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: Intraoperative, up to 5 hoursBlood loss during surgery (mL).
Outcome measures
| Measure |
Blood Pressure Managed by Cerebral Autoregulation
n=18 Participants
In this arm cerebral autoregulation monitoring will be used to determine the lower and upper limits of cerebral autoregulation. Monitoring will continue throughout the surgery. Blood pressure management will be maintained to be within the limits of cerebral autoregulation.
|
Standard of Care Blood Pressure Management
n=7 Participants
In this arm cerebral autoregulation monitoring will be used for observation. The anesthesia provider will use usual care guidelines for blood pressure management.
|
|---|---|---|
|
Estimated Blood Loss
|
17.5 mL
Standard Deviation 17.8
|
12.9 mL
Standard Deviation 19.8
|
PRIMARY outcome
Timeframe: In the hospital after surgery, up to 2 weeksClinically diagnosed new myocardial infarction after surgery as a measure of incidence.
Outcome measures
| Measure |
Blood Pressure Managed by Cerebral Autoregulation
n=18 Participants
In this arm cerebral autoregulation monitoring will be used to determine the lower and upper limits of cerebral autoregulation. Monitoring will continue throughout the surgery. Blood pressure management will be maintained to be within the limits of cerebral autoregulation.
|
Standard of Care Blood Pressure Management
n=7 Participants
In this arm cerebral autoregulation monitoring will be used for observation. The anesthesia provider will use usual care guidelines for blood pressure management.
|
|---|---|---|
|
Number of Participants With New Myocardial Infarction After Surgery
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: In the hospital after surgery, up to 2 weeksClinically diagnosed new stroke after surgery as a measure of incidence.
Outcome measures
| Measure |
Blood Pressure Managed by Cerebral Autoregulation
n=18 Participants
In this arm cerebral autoregulation monitoring will be used to determine the lower and upper limits of cerebral autoregulation. Monitoring will continue throughout the surgery. Blood pressure management will be maintained to be within the limits of cerebral autoregulation.
|
Standard of Care Blood Pressure Management
n=7 Participants
In this arm cerebral autoregulation monitoring will be used for observation. The anesthesia provider will use usual care guidelines for blood pressure management.
|
|---|---|---|
|
Number of Participants With New Stroke After Surgery
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: In the hospital during the first 3 days after surgeryDevelopment of delirium after surgery as diagnosed by the 3-Minute, Diagnostic Interview for Confusion Assessment Method (3D-CAM) or CAM-ICU.
Outcome measures
| Measure |
Blood Pressure Managed by Cerebral Autoregulation
n=18 Participants
In this arm cerebral autoregulation monitoring will be used to determine the lower and upper limits of cerebral autoregulation. Monitoring will continue throughout the surgery. Blood pressure management will be maintained to be within the limits of cerebral autoregulation.
|
Standard of Care Blood Pressure Management
n=7 Participants
In this arm cerebral autoregulation monitoring will be used for observation. The anesthesia provider will use usual care guidelines for blood pressure management.
|
|---|---|---|
|
Number of Participants That Develop Delirium After Surgery
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Approximately 60, 180, and 365 Days after SurgeryWill be assessed via Short Blessed Test. Scores range from 0-28 with 0 indicating no cognitive impairment and 28 indicating severe cognitive impairment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 60, 180, and 365 Days after SurgeryWill be assessed via Oral Trail Making Test. The test is timed, and shorter times indicate better performance and longer times indicate worse performance.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 365 Days after SurgeryWill be assessed via the Eight-item Interview to Differentiate Aging and Dementia Test (AD8). Scores range from 0-8 with 0 indicating no cognitive impairment and 8 indicating severe cognitive impairment consistent with dementia
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 60, 180, and 365 Days after SurgeryWill be assessed via the World Health Organization (WHO) Disability Assessment Schedule 2.0 (WHO-DAS 2.0). Scores range from 0-100 with 0 indicating no disability and 100 indicating severe disability.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 60, 180, and 365 Days after SurgeryScore on Instrumental Activities of Daily Living. Scores range from 0-8, with 0 indicating severe impairment and 8 indicating no impairment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 60, 180, and 365 Days after SurgeryInability to walk more than 10 feet without human assistance.
Outcome measures
Outcome data not reported
Adverse Events
Blood Pressure Managed by Cerebral Autoregulation
Serious events: 8 serious events
Other events: 6 other events
Deaths: 1 deaths
Standard of Care Blood Pressure Management
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Blood Pressure Managed by Cerebral Autoregulation
n=18 participants at risk
In this arm cerebral autoregulation monitoring will be used to determine the lower and upper limits of cerebral autoregulation. Monitoring will continue throughout the surgery. Blood pressure management will be maintained to be within the limits of cerebral autoregulation.
Blood pressure management according to cerebral autoregulation: Intraoperative blood pressure will be targeted based on limits of cerebral autoregulation.
|
Standard of Care Blood Pressure Management
n=7 participants at risk
In this arm cerebral autoregulation monitoring will be used for observation. The anesthesia provider will use usual care guidelines for blood pressure management.
Blood pressure management according to usual care: Intraoperative blood pressure will be targeted based on usual care.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
5.6%
1/18 • Number of events 1 • Up to 13-months
|
0.00%
0/7 • Up to 13-months
|
|
Renal and urinary disorders
Hematuria or UTI
|
5.6%
1/18 • Number of events 2 • Up to 13-months
|
14.3%
1/7 • Number of events 2 • Up to 13-months
|
|
Cardiac disorders
Atrial Fibrillation
|
5.6%
1/18 • Number of events 1 • Up to 13-months
|
14.3%
1/7 • Number of events 1 • Up to 13-months
|
|
Infections and infestations
Sepsis
|
5.6%
1/18 • Number of events 1 • Up to 13-months
|
0.00%
0/7 • Up to 13-months
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
5.6%
1/18 • Number of events 1 • Up to 13-months
|
0.00%
0/7 • Up to 13-months
|
|
Respiratory, thoracic and mediastinal disorders
Effusion
|
5.6%
1/18 • Number of events 1 • Up to 13-months
|
14.3%
1/7 • Number of events 1 • Up to 13-months
|
|
Cardiac disorders
Myocardial infarction
|
5.6%
1/18 • Number of events 1 • Up to 13-months
|
0.00%
0/7 • Up to 13-months
|
|
Nervous system disorders
Stroke
|
5.6%
1/18 • Number of events 1 • Up to 13-months
|
0.00%
0/7 • Up to 13-months
|
|
Gastrointestinal disorders
Bowel obstruction
|
5.6%
1/18 • Number of events 1 • Up to 13-months
|
0.00%
0/7 • Up to 13-months
|
Other adverse events
| Measure |
Blood Pressure Managed by Cerebral Autoregulation
n=18 participants at risk
In this arm cerebral autoregulation monitoring will be used to determine the lower and upper limits of cerebral autoregulation. Monitoring will continue throughout the surgery. Blood pressure management will be maintained to be within the limits of cerebral autoregulation.
Blood pressure management according to cerebral autoregulation: Intraoperative blood pressure will be targeted based on limits of cerebral autoregulation.
|
Standard of Care Blood Pressure Management
n=7 participants at risk
In this arm cerebral autoregulation monitoring will be used for observation. The anesthesia provider will use usual care guidelines for blood pressure management.
Blood pressure management according to usual care: Intraoperative blood pressure will be targeted based on usual care.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fall
|
5.6%
1/18 • Number of events 1 • Up to 13-months
|
28.6%
2/7 • Number of events 2 • Up to 13-months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax prolonged
|
5.6%
1/18 • Number of events 1 • Up to 13-months
|
42.9%
3/7 • Number of events 3 • Up to 13-months
|
|
Musculoskeletal and connective tissue disorders
low back pain
|
5.6%
1/18 • Number of events 1 • Up to 13-months
|
0.00%
0/7 • Up to 13-months
|
|
Musculoskeletal and connective tissue disorders
Subcutaneous Emphysema
|
11.1%
2/18 • Number of events 2 • Up to 13-months
|
28.6%
2/7 • Number of events 2 • Up to 13-months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.6%
1/18 • Number of events 1 • Up to 13-months
|
0.00%
0/7 • Up to 13-months
|
|
Nervous system disorders
Delirium
|
5.6%
1/18 • Number of events 1 • Up to 13-months
|
14.3%
1/7 • Number of events 1 • Up to 13-months
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
5.6%
1/18 • Number of events 1 • Up to 13-months
|
0.00%
0/7 • Up to 13-months
|
|
Nervous system disorders
Dementia
|
0.00%
0/18 • Up to 13-months
|
14.3%
1/7 • Number of events 1 • Up to 13-months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/18 • Up to 13-months
|
14.3%
1/7 • Number of events 1 • Up to 13-months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place