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

Sponsor

University Hospital Hradec Kralove (Other)

Overall Status

Completed

CT.gov ID

NCT03093311

Collaborator

(none)

100

Enrollment

Location

Arms

26.9

Actual Duration (Months)

3.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Dysfunction Patient Positioning	Other: NIRS based protocol	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2017

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A Brain tissue oxygenation is measured by NIRS. In time of desaturation the interventions according to NIRS based protocol start.	Other: NIRS based protocol 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.
No Intervention: Arm B Brain tissue oxygenation is not measured.

Arm

Intervention/Treatment

Experimental: Arm A

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

Other: NIRS based protocol

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.

No Intervention: Arm B

Brain tissue oxygenation is not measured.

Outcome Measures

Primary Outcome Measures

Reduction of incidence of postoperative cognitive dysfunction (POCD) [1 day before operation and the fifth´day]
Addenbrooke test

Secondary Outcome Measures

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
Type and duration of procedure [10 minutes after procedure]
In minutes
Dose of catecholamines [5 minutes after procedure]
In microgramms per kg per minute

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Hradec Kralove	Hradec Kralove		Czechia	50005

Sponsors and Collaborators

University Hospital Hradec Kralove

Investigators

Principal Investigator: Vlasta Dostalova, MD, PhD, University Hospital Hradec Kralove

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove, Czech Republic, University Hospital Hradec Kralove

ClinicalTrials.gov Identifier:

NCT03093311

Other Study ID Numbers:

UHHradecKralove 2017/01

First Posted:

Mar 28, 2017

Last Update Posted:

Oct 1, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove, Czech Republic, University Hospital Hradec Kralove

Near-Infrared Spectroscopy

Neurosurgical Procedures

Cognitive Dysfunction

Additional relevant MeSH terms:

Cognitive Dysfunction

Study Results

No Results Posted as of Oct 1, 2019