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

NCT03093311 | Completed

• 1 other identifier: UHHradecKralove 2017/01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Dysfunction; Patient Positioning

Keywords

Near-Infrared Spectroscopy; Neurosurgical Procedures; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• Reduction of incidence of postoperative cognitive dysfunction (POCD)

  Addenbrooke test

  1 day before operation and the fifth´day

Secondary Outcomes (5)

• Operative position of patient

  first 30 minutes

• Age of patients

  the first 5 minutes

• Level of exhaled carbon dioxide

  every 5 minutes

• Type and duration of procedure

  10 minutes after procedure

• Dose of catecholamines

  5 minutes after procedure

Study Arms (2)

Arm A

EXPERIMENTAL

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

Other: NIRS based protocol

Arm B

NO INTERVENTION

Brain tissue oxygenation is not measured.

Interventions

NIRS based protocol OTHER

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.

Arm A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Vlasta Dostalova, MD, PhD

  University Hospital Hradec Kralove

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Hospital Hradec Kralove, Czech Republic

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 28, 2017
• Study Start: April 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: June 30, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)