NIRS vs TCD for Cerebrovascular Autoregulation During Non-cardiac Surgery

NCT04978558 | Completed

• 1 other identifier: SONICA
• Study Type: observational
• Target: 509
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative neurocognitive disorders (NCD) are of high priority in perioperative management. The risk of suffering from NCD after surgery may be increased due to perioperative impairment of cerebrovascular autoregulation and thereby inadequate cerebral perfusion. Cerebrovascular autoregulation refers to the ability of cerebral arterioles to ensure constant cerebral blood flow independently of fluctuations in systemic blood pressure. Cerebrovascular autoregulation can be measured based on mean arterial pressure (MAP) and a surrogate for cerebral blood flow using the correlation method. Until today, measurement of cerebral blood flow velocity assessed with transcranial Doppler sonography (TCD) is most commonly used as a non-invasive surrogate for cerebral blood flow. Alternatively, cerebral oxygenation measured with near-infrared spectroscopy (NIRS) can be used as another surrogate. The study includes three substudies:

1. 1.To compare NIRS and TCD for the assessment of perioperative cerebrovascular autoregulation in patients undergoing major non-cardiac surgery with an increased risk of bleeding.
2. 2.To compare MAP for optimal cerebrovascular autoregulation before induction of general anesthesia with MAP for optimal cerebrovascular autoregulation during or after general anesthesia.
3. 3.To analyze the association between the time-weighted average MAP below the MAP for optimal cerebrovascular autoregulation and postoperative NCD.

Conditions

Cerebrovascular Circulation

Keywords

postoperative neurocognitive disorders; postoperative delirium; near-infrared spectroscopy; transcranial Doppler sonography; non-cardiac surgery

Outcome Measures

Primary Outcomes (3)

• Equivalence of NIRS-based and TCD-based intraoperative measurement of cerebrovascular autoregulation

  calculation of cerebral autoregulation indices based on near-infrared spectroscopy and transcranial Doppler sonography

  up to 4 hours during surgery

• optimal MAP during NIRS-based measurement of cerebrovascular autoregulation

  MAP at lowest cerebral autoregulation index COx

  up to 2 hours after surgery

• delirium and postoperative NCD after surgery (composite)

  screening for postoperative delirium; neuropsychological testing for the assessment of cognitive function

  days 1 to 4 after surgery (delirium), day 7 after surgery or at day of discharge from hospital (NCD)

Secondary Outcomes (6)

• optimal MAP during TCD-based measurement of cerebrovascular autoregulation

  up to 4 hours during surgery

• postoperative delirium between day 1 and 4 after surgery

  days 1 to 4 after surgery

• delayed neurocognitive recovery at day 7 after surgery or before hospital discharge

  day 7 after surgery or at day of discharge from hospital

• length of hospital stay

  date of discharge from hospital (up to 30 days)

• length of ICU stay

  date of discharge from ICU (up to 30 days)

Interventions

Continuous assessment of cerebrovascular autoregulation with NIRS and TCD OTHER

Continuous monitoring of MAP, cerebral oxygenation, and cerebral blood flow velocity before, during, and after surgery to calculate two cerebrovascular autoregulation indices Cox and Mx.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for non-cardiac surgery with general anesthesia at a tertiary care hospital

You may qualify if:

• Age ≥ 18 years
• Elective surgery with a minimum duration of 120 minutes
• General anesthesia
• expected blood loss \> 500 ml

You may not qualify if:

• Temporal bone window failure (substudy 1)
• Cerebrovascular disease
• Cardiac surgery
• Neurosurgery

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Department of Anesthesiology, University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Marlene Fischer, MD, PhD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: July 27, 2021
• Study Start: August 9, 2021
• Primary Completion: September 29, 2023
• Study Completion: September 19, 2024
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)