NIRS vs TCD for Cerebrovascular Autoregulation During Non-cardiac Surgery

NCT ID: NCT04978558

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

509 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-09

Study Completion Date

2024-09-19

Brief Summary

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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. 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. To compare MAP for optimal cerebrovascular autoregulation before induction of general anesthesia with MAP for optimal cerebrovascular autoregulation during or after general anesthesia.
3. To analyze the association between the time-weighted average MAP below the MAP for optimal cerebrovascular autoregulation and postoperative NCD.

Detailed Description

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Conditions

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Cerebrovascular Circulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Continuous assessment of cerebrovascular autoregulation with NIRS and TCD

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Temporal bone window failure (substudy 1)
* Cerebrovascular disease
* Cardiac surgery
* Neurosurgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marlene Fischer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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Department of Anesthesiology, University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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SONICA

Identifier Type: -

Identifier Source: org_study_id

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