NIRS vs TCD for Cerebrovascular Autoregulation During Non-cardiac Surgery

Cerebrovascular Circulation Clinical Trial

— SONICA  

Official title:

Cerebrovascular Autoregulation During Major Non-cardiac Surgery - a Comparison Between Near Infrared Spectroscopy and Transcranial Doppler Sonography

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04978558
• Other study ID #: SONICA
• Status: Not yet recruiting
• Start date: August 2021
• Est. completion date: February 2023

Study information

• Verified date: August 2021
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Marlene Fischer, MD, PhD
• Phone: +4915222827500
• Email: mar.fischer[@]uke.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 509
• Est. completion date: February 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Circulation

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Germany	Department of Anesthesiology, University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	continuous assessment during the entire surgical procedure
Primary	optimal MAP during NIRS-based measurement of cerebrovascular autoregulation	MAP at lowest cerebral autoregulation index COx	30 minutes before anesthesia induction (n=38)/ from surgical incision up to two hours after arrival in the post-anesthesia care unit (all patients)
Primary	delirium and postoperative NCD after surgery (composite)	screening for postoperative delirium; neuropsychological testing for the assessment of cognitive function	postoperative days 1-4 (delirium), postoperative day 7 or before hospital discharge (NCD)
Secondary	optimal MAP during TCD-based measurement of cerebrovascular autoregulation	MAP at lowest cerebral autoregulation index (Mx)	from surgical incision until the end of surgical procedure
Secondary	postoperative delirium between day 1 and 4 after surgery	screening for postoperative delirium	postoperative day 1 to 4
Secondary	delayed neurocognitive recovery at day 7 after surgery or before hospital discharge	neuropsychological assessment	postoperative day 7 or before hospital discharge
Secondary	NCD at 3 months after surgery	neuropsychological assessment	3 months after surgery
Secondary	length of hospital stay		at discharge from hospital
Secondary	length of ICU stay		at discharge from ICU
Secondary	mortality at 3 months after surgery		3 months after surgery