Detection and Classification of Levels of Consciousness Using Parietal EEG-fNIRS During Anesthesia

NCT05112042 | Completed

• 1 other identifier: 210716001
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The current evaluations of the levels of consciousness during anesthesia have limited precision. This can produce negative clinical consequences such as intraoperative awareness or neurological damage due to under- or over-infusion of anesthesia, respectively. The study's objective is to determine and classify biomarkers of electrical and hemodynamical brain activity associated with the levels of consciousness between wakefulness and anesthesia. For this purpose, a parietal electroencephalography (EEG) and a functional near-infrared spectroscopy (fNIRS) measurement paradigm will be used, as well as machine-learning. Volunteering patients (n = 25), who will be subject to an endoscopy procedure, will be measured during the infusion of anesthesia with propofol. EEG and fNIRS parameters will then be related to the Modified Ramsay clinical scale of consciousness.

Conditions

Anesthesia; Consciousness, Loss of

Keywords

Anesthesia; Consciousness; Endoscopy; fNIRS; Propofol; Parietal; Electroencephalography; Functional near-infrared spectroscopy; EEG; Machine learning

Outcome Measures

Primary Outcomes (3)

• Brain electrophysiological activity by electroencephalography wavelength band powers

  The delta (0.1-3 Hz), theta (4-7 Hz), lower-alpha (8-12 Hz), upper-alpha (12-15 Hz), and beta/gamma (15-40 Hz) electroencephalography wavelength band powers will be used as features for the decoding model.

  During the whole endoscopy and recovery (1 - 2 hours)

• Temporal brain oxygenation by near-infrared light spectroscopy wavelengths

  The temporal brain area of the oxygenated (HbO2) and deoxygenated (HHb) hemoglobin will be obtained from the optical signals, using the modified Beer-Lambert law.

  During the whole endoscopy and recovery (1 - 2 hours)

• Levels of Consciousness with the Modified Ramsay Sedation Scale

  During infusion, the Modified Ramsay Scale will be used by the anesthetist in charge to measure the patient's level of consciousness. This scale has a total of eight levels, each of which indicates an increasing level of unconsciousness, assessed qualitatively by the patient's response to verbal or painful stimuli. The level of consciousness will be evaluated every two minutes until complete loss of consciousness, which is assumed after the loss of defensive or purposeful response to a second standard tetanic stimulation.

  20 minutes

Secondary Outcomes (1)

• BRICE survey responses

  10 minutes

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Relatively healthy volunteering patients, within 20 to 40 years of age, who will undergo an endoscopy procedure and meet all the eligibility criteria.

You may qualify if:

• ASA I or II
• Patients who will undergo an endoscopy procedure

You may not qualify if:

• Alcohol or drug consumption within 48 hours
• Known or suspected pregnancy
• Any diagnosed psychiatric condition
• Any diagnosed neurological condition or implant
• Any diagnosed chronic disease

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Centro de Especialidades Médicas UC

Santiago, Santiago Metropolitan, 8320000, Chile

Location

Related Publications (15)

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  PMID: 32855048 BACKGROUND

• Campbell JM, Huang Z, Zhang J, Wu X, Qin P, Northoff G, Mashour GA, Hudetz AG. Pharmacologically informed machine learning approach for identifying pathological states of unconsciousness via resting-state fMRI. Neuroimage. 2020 Feb 1;206:116316. doi: 10.1016/j.neuroimage.2019.116316. Epub 2019 Oct 29.

  PMID: 31672663 BACKGROUND

• Davidson AJ. Anesthesia and neurotoxicity to the developing brain: the clinical relevance. Paediatr Anaesth. 2011 Jul;21(7):716-21. doi: 10.1111/j.1460-9592.2010.03506.x. Epub 2011 Apr 6.

  PMID: 21466608 BACKGROUND

• Hirota K. Special cases: ketamine, nitrous oxide and xenon. Best Pract Res Clin Anaesthesiol. 2006 Mar;20(1):69-79. doi: 10.1016/j.bpa.2005.08.014.

  PMID: 16634415 BACKGROUND

• Saadeh W, Khan FH, Altaf MAB. Design and Implementation of a Machine Learning Based EEG Processor for Accurate Estimation of Depth of Anesthesia. IEEE Trans Biomed Circuits Syst. 2019 Aug;13(4):658-669. doi: 10.1109/TBCAS.2019.2921875. Epub 2019 Jun 10.

  PMID: 31180871 BACKGROUND

• Kotsovolis G, Komninos G. Awareness during anesthesia: how sure can we be that the patient is sleeping indeed? Hippokratia. 2009 Apr;13(2):83-9.

  PMID: 19561776 BACKGROUND

• Lee, M. H., Fazli, S., Mehnert, J., & Lee, S. W. (2015). Subject-dependent classification for robust idle state detection using multi-modal neuroimaging and data-fusion techniques in BCI. Pattern Recognition, 48(8), 2725-2737. https://doi.org/10.1016/j.patcog.2015.03.010

  BACKGROUND

• Leon-Dominguez U, Izzetoglu M, Leon-Carrion J, Solis-Marcos I, Garcia-Torrado FJ, Forastero-Rodriguez A, Mellado-Miras P, Villegas-Duque D, Lopez-Romero JL, Onaral B, Izzetoglu K. Molecular concentration of deoxyHb in human prefrontal cortex predicts the emergence and suppression of consciousness. Neuroimage. 2014 Jan 15;85 Pt 1:616-25. doi: 10.1016/j.neuroimage.2013.07.023. Epub 2013 Jul 17.

  PMID: 23872157 BACKGROUND

• Levitt DG, Schnider TW. Human physiologically based pharmacokinetic model for propofol. BMC Anesthesiol. 2005 Apr 22;5(1):4. doi: 10.1186/1471-2253-5-4.

  PMID: 15847680 BACKGROUND

• Sheahan CG, Mathews DM. Monitoring and delivery of sedation. Br J Anaesth. 2014 Dec;113 Suppl 2:ii37-47. doi: 10.1093/bja/aeu378.

  PMID: 25498581 BACKGROUND

• Sebel PS, Bowdle TA, Ghoneim MM, Rampil IJ, Padilla RE, Gan TJ, Domino KB. The incidence of awareness during anesthesia: a multicenter United States study. Anesth Analg. 2004 Sep;99(3):833-839. doi: 10.1213/01.ANE.0000130261.90896.6C.

  PMID: 15333419 BACKGROUND

• Sepulveda P, Cortinez LI, Irani M, Egana JI, Contreras V, Sanchez Corzo A, Acosta I, Sitaram R. Differential frontal alpha oscillations and mechanisms underlying loss of consciousness: a comparison between slow and fast propofol infusion rates. Anaesthesia. 2020 Feb;75(2):196-201. doi: 10.1111/anae.14885. Epub 2019 Dec 1.

  PMID: 31788791 BACKGROUND

• Sitaram R, Ros T, Stoeckel L, Haller S, Scharnowski F, Lewis-Peacock J, Weiskopf N, Blefari ML, Rana M, Oblak E, Birbaumer N, Sulzer J. Closed-loop brain training: the science of neurofeedback. Nat Rev Neurosci. 2017 Feb;18(2):86-100. doi: 10.1038/nrn.2016.164. Epub 2016 Dec 22.

  PMID: 28003656 BACKGROUND

• Yeom SK, Won DO, Chi SI, Seo KS, Kim HJ, Muller KR, Lee SW. Spatio-temporal dynamics of multimodal EEG-fNIRS signals in the loss and recovery of consciousness under sedation using midazolam and propofol. PLoS One. 2017 Nov 9;12(11):e0187743. doi: 10.1371/journal.pone.0187743. eCollection 2017.

  PMID: 29121108 BACKGROUND

• Zimeo Morais GA, Balardin JB, Sato JR. fNIRS Optodes' Location Decider (fOLD): a toolbox for probe arrangement guided by brain regions-of-interest. Sci Rep. 2018 Feb 20;8(1):3341. doi: 10.1038/s41598-018-21716-z.

  PMID: 29463928 BACKGROUND

Related Links

• Kothe, C. (2014). Lab streaming layer (LSL)

MeSH Terms

Conditions

Unconsciousness

Condition Hierarchy (Ancestors)

Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Catalina A Saini

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BS

Study Record Dates

• First Submitted: October 10, 2021
• First Posted: November 8, 2021
• Study Start: May 14, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)