NIRS vs TCD for Cerebrovascular Autoregulation During Non-cardiac Surgery
- Conditions
- Cerebrovascular Circulation
- Registration Number
- NCT04978558
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 509
- Age ≥ 18 years
- Elective surgery with a minimum duration of 120 minutes
- General anesthesia
- expected blood loss > 500 ml
- Temporal bone window failure
- Cerebrovascular disease
- Cardiac surgery
- Neurosurgery
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Equivalence of NIRS-based and TCD-based intraoperative measurement of cerebrovascular autoregulation continuous assessment during the entire surgical procedure calculation of cerebral autoregulation indices based on near-infrared spectroscopy and transcranial Doppler sonography
optimal MAP during NIRS-based measurement of cerebrovascular autoregulation 30 minutes before anesthesia induction (n=38)/ from surgical incision up to two hours after arrival in the post-anesthesia care unit (all patients) MAP at lowest cerebral autoregulation index COx
delirium and postoperative NCD after surgery (composite) postoperative days 1-4 (delirium), postoperative day 7 or before hospital discharge (NCD) screening for postoperative delirium; neuropsychological testing for the assessment of cognitive function
- Secondary Outcome Measures
Name Time Method optimal MAP during TCD-based measurement of cerebrovascular autoregulation from surgical incision until the end of surgical procedure MAP at lowest cerebral autoregulation index (Mx)
delayed neurocognitive recovery at day 7 after surgery or before hospital discharge postoperative day 7 or before hospital discharge neuropsychological assessment
postoperative delirium between day 1 and 4 after surgery postoperative day 1 to 4 screening for postoperative delirium
length of hospital stay at discharge from hospital length of ICU stay at discharge from ICU NCD at 3 months after surgery 3 months after surgery neuropsychological assessment
mortality at 3 months after surgery 3 months after surgery
Trial Locations
- Locations (1)
Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
🇩🇪Hamburg, Germany