Optimizing Cerebral Autoregulation During Surgery

Surgery Clinical Trial

Official title:

Optimizing Cerebral Autoregulation During Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05308290
• Other study ID #: IRB00137091
• Secondary ID: K76AG057020
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: September 12, 2025

Study information

• Verified date: March 2024
• Source: Johns Hopkins University
• Contact: Mirinda Anderson White
• Phone: 410-955-6488
• Email: mander47[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 77
• Est. completion date: September 12, 2025
• Est. primary completion date: September 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Hip Arthropathy
• Hip Fractures
• Surgery

Intervention

Other:
• Blood pressure management according to cerebral autoregulation
Intraoperative blood pressure will be targeted based on limits of cerebral autoregulation.
• Blood pressure management according to usual care
Intraoperative blood pressure will be targeted based on usual care.

Locations

Country	Name	City	State
United States	The Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Intraoperative, up to 5 hours
Primary	Estimated Blood Loss	Blood loss during surgery (mL).	Intraoperative, up to 5 hours
Primary	Incidence of new Myocardial Infarction after surgery	Clinically diagnosed new myocardial infarction after surgery.	In the hospital after surgery, up to 1 week
Primary	Incidence of new Stroke after surgery	Clinically diagnosed new stroke after surgery.	In the hospital after surgery, up to 1 week
Secondary	Number of participants that develop delirium after surgery	Delirium as diagnosed by the 3D-CAM or CAM-ICU.	In the hospital during the first 3 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.	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.	Approximately 60, 180, and 365 Days after Surgery
Secondary	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	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.	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.	Approximately 60, 180, and 365 Days after Surgery
Secondary	Change in ability to Ambulate without human assistance	Inability to walk more than 10 feet without human assistance.	Approximately 60, 180, and 365 Days after Surgery