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

Primary Purpose

Cognitive Dysfunction, Patient Positioning

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
NIRS based protocol
Sponsored by
University Hospital Hradec Kralove
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Dysfunction focused on measuring Near-Infrared Spectroscopy, Neurosurgical Procedures, Cognitive Dysfunction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Hospital Hradec Kralove

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm A

Arm B

Arm Description

Brain tissue oxygenation is measured by NIRS. In time of desaturation the interventions according to NIRS based protocol start.

Brain tissue oxygenation is not measured.

Outcomes

Primary Outcome Measures

Reduction of incidence of postoperative cognitive dysfunction (POCD)
Addenbrooke test

Secondary Outcome Measures

Operative position of patient
In grades from neutral position
Age of patients
18 to 79
Level of exhaled carbon dioxide
In torr
Type and duration of procedure
In minutes
Dose of catecholamines
In microgramms per kg per minute

Full Information

First Posted
March 14, 2017
Last Updated
September 28, 2019
Sponsor
University Hospital Hradec Kralove
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1. Study Identification

Unique Protocol Identification Number
NCT03093311
Brief Title
Near Infrared Spectroscopy for Detection of Cerebral Desaturation After Positioning for Neurosurgical Procedures
Official Title
Near Infrared Spectroscopy for Detection of Cerebral Desaturation After Positioning for Neurosurgical Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Hradec Kralove

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction, Patient Positioning
Keywords
Near-Infrared Spectroscopy, Neurosurgical Procedures, Cognitive Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Brain tissue oxygenation is measured by NIRS. In time of desaturation the interventions according to NIRS based protocol start.
Arm Title
Arm B
Arm Type
No Intervention
Arm Description
Brain tissue oxygenation is not measured.
Intervention Type
Other
Intervention Name(s)
NIRS based protocol
Intervention Description
Each desaturation episode will be managed according to a standardized protocol - correction of extreme head position will be followed by optimisation of mean arterial pressure (MAP), arterial hemoglobin oxygen saturation, end tidal carbon dioxide concentration and a level of hemoglobine concentration.
Primary Outcome Measure Information:
Title
Reduction of incidence of postoperative cognitive dysfunction (POCD)
Description
Addenbrooke test
Time Frame
1 day before operation and the fifth´day
Secondary Outcome Measure Information:
Title
Operative position of patient
Description
In grades from neutral position
Time Frame
first 30 minutes
Title
Age of patients
Description
18 to 79
Time Frame
the first 5 minutes
Title
Level of exhaled carbon dioxide
Description
In torr
Time Frame
every 5 minutes
Title
Type and duration of procedure
Description
In minutes
Time Frame
10 minutes after procedure
Title
Dose of catecholamines
Description
In microgramms per kg per minute
Time Frame
5 minutes after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vlasta Dostalova, MD, PhD
Organizational Affiliation
University Hospital Hradec Kralove
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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