Delirium, Hip Arthropathy, Hip Fractures, Surgery
Conditions
Brief summary
The purpose of this study is to conduct a pilot trial to determine the feasibility, safety, and potential efficacy of targeting mean arterial blood pressure (MAP) within the limits of cerebral autoregulation during surgery compared with usual care.
Interventions
OTHERBlood pressure management according to cerebral autoregulation
Intraoperative blood pressure will be targeted based on limits of cerebral autoregulation.
OTHERBlood pressure management according to usual care
Intraoperative blood pressure will be targeted based on usual care.
Sponsors
National Institute on Aging (NIA)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* planned hip or knee surgery (either for fracture or elective) or lung surgery * age ≥60 * ambulatory at baseline * expected duration of surgery \> 90 minutes
Exclusion criteria
* Planned concurrent surgery * Allergy to adhesive tape * Short Blessed Test score \>20 * Clinical diagnosis of dementia * Opinion of either the anesthesiologist or surgeon that the patient is not appropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Arterial Pressure Outside Limits of Cerebral Autoregulation | Intraoperative, up to 5 hours | Extent (mmHg \* hours) of mean arterial pressure outside limits of cerebral autoregulation after establishment of target mean arterial pressure. |
| Estimated Blood Loss | Intraoperative, up to 5 hours | Blood loss during surgery (mL). |
| Number of Participants With New Myocardial Infarction After Surgery | In the hospital after surgery, up to 2 weeks | Clinically diagnosed new myocardial infarction after surgery as a measure of incidence. |
| Number of Participants With New Stroke After Surgery | In the hospital after surgery, up to 2 weeks | Clinically diagnosed new stroke after surgery as a measure of incidence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in General Overall Health and Disability as Assessed by the WHO Disability Assessment Schedule 2.0 | Approximately 60, 180, and 365 Days after Surgery | Will 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. |
| Number of Participants That Develop Delirium After Surgery | In the hospital during the first 3 days after surgery | Development of delirium after surgery as diagnosed by the 3-Minute, Diagnostic Interview for Confusion Assessment Method (3D-CAM) or CAM-ICU. |
| Change in Ability to Ambulate Without Human Assistance | Approximately 60, 180, and 365 Days after Surgery | Inability to walk more than 10 feet without human assistance. |
| Change in General Function as Assessed by the Instrumental Activities of Daily Living Questionnaire | Approximately 60, 180, and 365 Days after Surgery | Score on Instrumental Activities of Daily Living. Scores range from 0-8, with 0 indicating severe impairment and 8 indicating no impairment. |
| Change in General Cognitive Function as Assessed by the Short Blessed Test | Approximately 60, 180, and 365 Days after Surgery | Will be assessed via Short Blessed Test. Scores range from 0-28 with 0 indicating no cognitive impairment and 28 indicating severe cognitive impairment. |
| Change in Executive Cognitive Function as Assessed by the Oral Trail Making Test | Approximately 60, 180, and 365 Days after Surgery | Will be assessed via Oral Trail Making Test. The test is timed, and shorter times indicate better performance and longer times indicate worse performance. |
| Dementia Screening as Assessed by the AD8 Test | 365 Days after Surgery | Will 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 |
Countries
United States
Participant flow
Pre-assignment details
2 patients were excluded during secondary screen before randomization
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| 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. | 7 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | still in study followup | 0 | 1 |
Baseline characteristics
| Characteristic | Blood Pressure Managed by Cerebral Autoregulation | Standard of Care Blood Pressure Management | Total |
|---|---|---|---|
| Age, Continuous | 70.2 years STANDARD_DEVIATION 7.2 | 71.6 years STANDARD_DEVIATION 7.8 | 70.6 years STANDARD_DEVIATION 7.2 |
| Cardiac Arrhythmia | 1 Participants | 1 Participants | 2 Participants |
| Chronic Obstructive Pulmonary Disorder (COPD) | 1 Participants | 3 Participants | 4 Participants |
| Coronary Artery Disease | 3 Participants | 2 Participants | 5 Participants |
| Diabetes Mellitus | 4 Participants | 3 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 7 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hemoglobin (g/dl) | 13.2 (g/dl) STANDARD_DEVIATION 1.6 | 13.7 (g/dl) STANDARD_DEVIATION 0.7 | 13.3 (g/dl) STANDARD_DEVIATION 1.4 |
| Hypertension | 14 Participants | 5 Participants | 19 Participants |
| Past Stroke or Transient Ischemic Attack | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 7 Participants | 23 Participants |
| Region of Enrollment United States | 18 Participants | 7 Participants | 25 Participants |
| Sex: Female, Male Female | 10 Participants | 3 Participants | 13 Participants |
| Sex: Female, Male Male | 8 Participants | 4 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 18 | 0 / 7 |
| other Total, other adverse events | 6 / 18 | 5 / 7 |
| serious Total, serious adverse events | 8 / 18 | 3 / 7 |
Outcome results
Primary
Estimated Blood Loss
Blood loss during surgery (mL).
Time frame: Intraoperative, up to 5 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Pressure Managed by Cerebral Autoregulation | Estimated Blood Loss | 17.5 mL | Standard Deviation 17.8 |
| Standard of Care Blood Pressure Management | Estimated Blood Loss | 12.9 mL | Standard Deviation 19.8 |
p-value: 0.6t-test, 2 sided
Primary
Mean Arterial Pressure Outside Limits of Cerebral Autoregulation
Extent (mmHg \* hours) of mean arterial pressure outside limits of cerebral autoregulation after establishment of target mean arterial pressure.
Time frame: Intraoperative, up to 5 hours
Population: Signals did not work with one participant and no data was collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Pressure Managed by Cerebral Autoregulation | Mean Arterial Pressure Outside Limits of Cerebral Autoregulation | 2.2 mmHg * hours | Standard Deviation 2.1 |
| Standard of Care Blood Pressure Management | Mean Arterial Pressure Outside Limits of Cerebral Autoregulation | 1.8 mmHg * hours | Standard Deviation 1.2 |
p-value: 0.6t-test, 2 sided
Primary
Number of Participants With New Myocardial Infarction After Surgery
Clinically diagnosed new myocardial infarction after surgery as a measure of incidence.
Time frame: In the hospital after surgery, up to 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Blood Pressure Managed by Cerebral Autoregulation | Number of Participants With New Myocardial Infarction After Surgery | 0 Participants |
| Standard of Care Blood Pressure Management | Number of Participants With New Myocardial Infarction After Surgery | 0 Participants |
p-value: 1Fisher Exact
Primary
Number of Participants With New Stroke After Surgery
Clinically diagnosed new stroke after surgery as a measure of incidence.
Time frame: In the hospital after surgery, up to 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Blood Pressure Managed by Cerebral Autoregulation | Number of Participants With New Stroke After Surgery | 0 Participants |
| Standard of Care Blood Pressure Management | Number of Participants With New Stroke After Surgery | 0 Participants |
p-value: 1Fisher Exact
Secondary
Change in Ability to Ambulate Without Human Assistance
Inability to walk more than 10 feet without human assistance.
Time frame: Approximately 60, 180, and 365 Days after Surgery
Secondary
Change in Executive Cognitive Function as Assessed by the Oral Trail Making Test
Will be assessed via Oral Trail Making Test. The test is timed, and shorter times indicate better performance and longer times indicate worse performance.
Time frame: Approximately 60, 180, and 365 Days after Surgery
Secondary
Change in General Cognitive Function as Assessed by the Short Blessed Test
Will be assessed via Short Blessed Test. Scores range from 0-28 with 0 indicating no cognitive impairment and 28 indicating severe cognitive impairment.
Time frame: Approximately 60, 180, and 365 Days after Surgery
Secondary
Change in General Function as Assessed by the Instrumental Activities of Daily Living Questionnaire
Score on Instrumental Activities of Daily Living. Scores range from 0-8, with 0 indicating severe impairment and 8 indicating no impairment.
Time frame: Approximately 60, 180, and 365 Days after Surgery
Secondary
Change in General Overall Health and Disability as Assessed by the WHO Disability Assessment Schedule 2.0
Will 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.
Time frame: Approximately 60, 180, and 365 Days after Surgery
Secondary
Dementia Screening as Assessed by the AD8 Test
Will 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
Time frame: 365 Days after Surgery
Secondary
Number of Participants That Develop Delirium After Surgery
Development of delirium after surgery as diagnosed by the 3-Minute, Diagnostic Interview for Confusion Assessment Method (3D-CAM) or CAM-ICU.
Time frame: In the hospital during the first 3 days after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Blood Pressure Managed by Cerebral Autoregulation | Number of Participants That Develop Delirium After Surgery | 0 Participants |
| Standard of Care Blood Pressure Management | Number of Participants That Develop Delirium After Surgery | 1 Participants |
p-value: 0.28Fisher Exact