Optimizing Cerebral Autoregulation During Surgery

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05308290
• Collaborator: (none)
• Enrollment: 77
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 40
• Patients Per Site Per Month: 1.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Fractures; Hip Arthropathy; Surgery; Delirium	Other: Blood pressure management according to cerebral autoregulation; Other: Blood pressure management according to usual care	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Optimizing Cerebral Autoregulation During Surgery
• Anticipated Study Start Date: Aug 30, 2022
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Blood pressure management according to cerebral autoregulation; Intraoperative blood pressure will be targeted based on limits of cerebral autoregulation.
Active Comparator: 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.	Other: Blood pressure management according to usual care; Intraoperative blood pressure will be targeted based on usual care.

Outcome Measures

Primary Outcome Measures

1. Mean arterial pressure outside limits of cerebral autoregulation [Intraoperative, up to 5 hours]

   Extent (mmHg X hours) of mean arterial pressure outside limits of cerebral autoregulation after establishment of target mean arterial pressure.

2. Estimated Blood Loss [Intraoperative, up to 5 hours]

   Blood loss during surgery (mL).

3. Incidence of new Myocardial Infarction after surgery [In the hospital after surgery, up to 1 week]

   Clinically diagnosed new myocardial infarction after surgery.

4. Incidence of new Stroke after surgery [In the hospital after surgery, up to 1 week]

   Clinically diagnosed new stroke after surgery.

Secondary Outcome Measures

1. Number of participants that develop delirium after surgery [In the hospital during the first 3 days after surgery]

   Delirium as diagnosed by the 3D-CAM or CAM-ICU.

2. 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.

3. 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.

4. Dementia Screening as assessed by the AD8 test [365 Days after Surgery]

   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

5. 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.

6. 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.

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Johns Hopkins University	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University

Investigators

• Principal Investigator: Charles Brown, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT05308290
• Other Study ID Numbers: IRB00137091
• First Posted: Apr 4, 2022
• Last Update Posted: Jul 7, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Delirium; Hip Fractures

Study Results

No Results Posted as of Jul 7, 2022