Clinical trial NCT04978558: NIRS vs TCD for Cerebrovascular Autoregulation During Non-cardiac Surgery
Official title: Cerebrovascular Autoregulation During Major Non-cardiac Surgery - a Comparison Between Near Infrared Spectroscopy and Transcranial Doppler Sonography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebrovascular Circulation
Keywords: postoperative neurocognitive disorders
postoperative delirium
near-infrared spectroscopy
transcranial Doppler sonography
non-cardiac surgery
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 509
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for non-cardiac surgery with general anesthesia at a tertiary care hospital

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. 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.


Eligibility criteria: 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
* Cerebrovascular disease
* Cardiac surgery
* Neurosurgery

Primary outcomes:
measure: Equivalence of NIRS-based and TCD-based intraoperative measurement of cerebrovascular autoregulation
timeFrame: continuous assessment during the entire surgical procedure
measure: optimal MAP during NIRS-based measurement of cerebrovascular autoregulation
timeFrame: 30 minutes before anesthesia induction (n=38)/ from surgical incision up to two hours after arrival in the post-anesthesia care unit (all patients)
measure: delirium and postoperative NCD after surgery (composite)
timeFrame: postoperative days 1-4 (delirium), postoperative day 7 or before hospital discharge (NCD)
Secondary outcomes:
measure: optimal MAP during TCD-based measurement of cerebrovascular autoregulation
timeFrame: from surgical incision until the end of surgical procedure
measure: postoperative delirium between day 1 and 4 after surgery
timeFrame: postoperative day 1 to 4
measure: delayed neurocognitive recovery at day 7 after surgery or before hospital discharge
timeFrame: postoperative day 7 or before hospital discharge
measure: NCD at 3 months after surgery
timeFrame: 3 months after surgery
measure: length of hospital stay
timeFrame: at discharge from hospital
measure: length of ICU stay
timeFrame: at discharge from ICU
measure: mortality at 3 months after surgery
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Marlene Fischer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: