Optimizing Cerebral Autoregulation During Surgery
Primary Purpose
Hip Fractures, Hip Arthropathy, Surgery
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood pressure management according to cerebral autoregulation
Blood pressure management according to usual care
Sponsored by
About this trial
This is an interventional other trial for Hip Fractures
Eligibility Criteria
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.
Sites / Locations
- The Johns Hopkins UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Blood pressure managed by cerebral autoregulation
Standard of care blood pressure management
Arm Description
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.
In this arm cerebral autoregulation monitoring will be used for observation. The anesthesia provider will use usual care guidelines for blood pressure management.
Outcomes
Primary Outcome Measures
Mean arterial pressure outside limits of cerebral autoregulation
Extent (mmHg X hours) of mean arterial pressure outside limits of cerebral autoregulation after establishment of target mean arterial pressure.
Estimated Blood Loss
Blood loss during surgery (mL).
Incidence of new Myocardial Infarction after surgery
Clinically diagnosed new myocardial infarction after surgery.
Incidence of new Stroke after surgery
Clinically diagnosed new stroke after surgery.
Secondary Outcome Measures
Number of participants that develop delirium after surgery
Delirium as diagnosed by the 3D-CAM or CAM-ICU.
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.
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.
Dementia Screening as assessed by the AD8 test
Will be assessed via AD8. Scores range from 0-8 with 0 indicating no cognitive impairment and 8 indicating severe cognitive impairment consistent with dementia
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.
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.
Change in ability to Ambulate without human assistance
Inability to walk more than 10 feet without human assistance.
Full Information
NCT ID
NCT05308290
First Posted
March 24, 2022
Last Updated
October 2, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05308290
Brief Title
Optimizing Cerebral Autoregulation During Surgery
Official Title
Optimizing Cerebral Autoregulation During Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to conduct a pilot trial to determine the feasibility, safety, and potential efficacy of targeting MAP within the limits of cerebral autoregulation during surgery compared with usual care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Hip Arthropathy, Surgery, Delirium
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blood pressure managed by cerebral autoregulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care blood pressure management
Arm Type
Active Comparator
Arm Description
In this arm cerebral autoregulation monitoring will be used for observation. The anesthesia provider will use usual care guidelines for blood pressure management.
Intervention Type
Other
Intervention Name(s)
Blood pressure management according to cerebral autoregulation
Intervention Description
Intraoperative blood pressure will be targeted based on limits of cerebral autoregulation.
Intervention Type
Other
Intervention Name(s)
Blood pressure management according to usual care
Intervention Description
Intraoperative blood pressure will be targeted based on usual care.
Primary Outcome Measure Information:
Title
Mean arterial pressure outside limits of cerebral autoregulation
Description
Extent (mmHg X hours) of mean arterial pressure outside limits of cerebral autoregulation after establishment of target mean arterial pressure.
Time Frame
Intraoperative, up to 5 hours
Title
Estimated Blood Loss
Description
Blood loss during surgery (mL).
Time Frame
Intraoperative, up to 5 hours
Title
Incidence of new Myocardial Infarction after surgery
Description
Clinically diagnosed new myocardial infarction after surgery.
Time Frame
In the hospital after surgery, up to 1 week
Title
Incidence of new Stroke after surgery
Description
Clinically diagnosed new stroke after surgery.
Time Frame
In the hospital after surgery, up to 1 week
Secondary Outcome Measure Information:
Title
Number of participants that develop delirium after surgery
Description
Delirium as diagnosed by the 3D-CAM or CAM-ICU.
Time Frame
In the hospital during the first 3 days after surgery
Title
Change in general Cognitive Function as assessed by the Short Blessed Test
Description
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
Title
Change in Executive Cognitive Function as assessed by the Oral Trail Making Test
Description
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
Title
Dementia Screening as assessed by the AD8 test
Description
Will be assessed via 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
Title
Change in general overall health and Disability as assessed by the WHO Disability Assessment Schedule 2.0
Description
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
Title
Change in General function as assessed by the Instrumental Activities of Daily Living questionnaire
Description
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
Title
Change in ability to Ambulate without human assistance
Description
Inability to walk more than 10 feet without human assistance.
Time Frame
Approximately 60, 180, and 365 Days after Surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mirinda Anderson White
Phone
410-955-6488
Email
mander47@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Brown, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Brown, MD
Phone
410-955-0994
Email
cbrown12@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Mirinda Anderson, RN
Phone
410-955-6488
Email
mander47@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Charles Brown, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Optimizing Cerebral Autoregulation During Surgery
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