N/A N=25 Randomized Double-blind Other

Optimizing Cerebral Autoregulation During Surgery

Hip Fractures · Hip Arthropathy · Surgery · Delirium

Bottom Line

View on ClinicalTrials.gov: NCT05308290 ↗

Enrolled (actual)

Serious AEs

44.0%

Results posted

Jul 2025

Primary outcome: Primary: Mean Arterial Pressure Outside Limits of Cerebral Autoregulation — 2.2; 1.8 mmHg * hours — p=0.60

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Blood pressure management according to cerebral autoregulation (Other); Blood pressure management according to usual care (Other)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Jun 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Arterial Pressure Outside Limits of Cerebral Autoregulation	2.2; 1.8	0.60
PRIMARY Estimated Blood Loss	17.5; 12.9	0.60
PRIMARY Number of Participants With New Myocardial Infarction After Surgery	0; 0	1.0
PRIMARY Number of Participants With New Stroke After Surgery	0; 0	1.0
SECONDARY Number of Participants That Develop Delirium After Surgery	0; 1	0.28
SECONDARY Change in General Cognitive Function as Assessed by the Short Blessed Test	—	—
SECONDARY Change in Executive Cognitive Function as Assessed by the Oral Trail Making Test	—	—
SECONDARY Dementia Screening as Assessed by the AD8 Test	—	—
SECONDARY Change in General Overall Health and Disability as Assessed by the WHO Disability Assessment Schedule 2.0	—	—
SECONDARY Change in General Function as Assessed by the Instrumental Activities of Daily Living Questionnaire	—	—
SECONDARY Change in Ability to Ambulate Without Human Assistance	—	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05308290). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.