Near Infrared Spectroscopy for Detection of Cerebral Desaturation After Positioning for Neurosurgical Procedures

Not Applicable

Completed

• Conditions: Patient Positioning; Cognitive Dysfunction
• Interventions: Other: NIRS based protocol

• Registration Number: NCT03093311
• Lead Sponsor: University Hospital Hradec Kralove

Brief Summary

The occurrence of postoperative cognitive dysfunction (POCD) might be related to intraoperative cerebral desaturation. Positioning for neurosurgical procedures are associated with head rotation, elevation, flexion or extention that may affect blood brain inflow and outflow. Anatomical variations of Willis circle could affect the cerebral blood flow in extreme head position with the development of cerebral ischemia or functional changes of brain. Investigators suppose that detection of cerebral tissue desaturation and its prompt correction could modify the occurence of POCD after these procedures.

Detailed Description

Standardized anesthesia and perioperative care will be provided to all patiens with positioning for neurosurgical or spinal procedures, where the head is elevated, extended. flected or rotated. In group A before the start of general anesthesia, the baseline level of cerebral tissue oxygenation (rScO2) will be measured using the near-infrared spectroscopy NIRS (Invivo Medtronic) . Continuous measurement of rScO2 will be used for detection of cerebral tissue desaturation. Each desaturation episode will be managed according to a standardized protocol - correction of extreme head position will be followed by optimalisation of mean arterial pressure (MAP), arterial hemoglobin oxygen saturation, end tidal carbon dioxide concentration and a level of hemoglobine concentration. In group B neither measurement of rScO2 nor interventions are provided. Cognitive dysfunction will be assessed by Adenbrooke test before operation and on the fifth postoperative day.

Study Timeline

• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-28
• Study Start: 2017-04-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-06-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-28
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Glasgow Coma Scale 15, American Society of Anaesthesiologists (ASA) Physical Status Classification System Grade I-III, patient positioning with elevation, rotation, flexion or extention of head

Exclusion Criteria

• Inability to past the Addenbrooke test, postoperative ventilation, awake phase during surgery, lung disease with retention of carbon dioxide, neurological disease before surgery (aphasia, paresis, blindness, deafness)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	NIRS based protocol	Brain tissue oxygenation is measured by NIRS. In time of desaturation the interventions according to NIRS based protocol start.

Primary Outcome Measures

Name	Time	Method
Reduction of incidence of postoperative cognitive dysfunction (POCD)	1 day before operation and the fifth´day	Addenbrooke test

Secondary Outcome Measures

Name	Time	Method
Type and duration of procedure	10 minutes after procedure	In minutes
Dose of catecholamines	5 minutes after procedure	In microgramms per kg per minute
Operative position of patient	first 30 minutes	In grades from neutral position
Age of patients	the first 5 minutes	18 to 79
Level of exhaled carbon dioxide	every 5 minutes	In torr

Trial Locations

Locations (1)

University Hospital Hradec Kralove; 🇨🇿 Hradec Kralove, Czechia