AnesthesiaNCT05112042
Detection and Classification of Levels of Consciousness Using Parietal EEG-fNIRS During Anesthesia
An observational study of Anesthesia and Consciousness, Loss of, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Consciousness, Loss of
- How many people
- 13 participants
- Where
- 1 siteChile
- Study dates
- 14 May 2022to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- ASA I or II
- Patients who will undergo an endoscopy procedure
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Chile1 site
Centro de Especialidades Médicas UC
Santiago, Santiago Metropolitan, 8320000
About this study
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.
Read the detailed description
Devices for data acquisition The brain electrical signals will be measured with four electrodes and a Cyton OpenBCI board with a sampling frequency of 250 Hz. The brain hemodynamical signals will be measured with a NIRSport with 16 optodes and a sampling frequency of 15.525 Hz and a wavelength of 760 nm. The electrodes and optodes will be positioned in the parietal zone, following the recommended 10-5 system for the multimodal EEG-fNIRS paradigm. The software Lab Streaming Layer will be used to synchronize the EEG and fNIRS data.
Data acquisition Patients will be summoned 30 minutes before their clinical appointment to put, adjust and calibrate the EEG and fNIRS systems. A 5-minute baseline measurement will be performed before the endoscopy procedure, with eyes closed. Afterward, patients will be anesthetized with a constant infusion rate of 20 mg/kg/h-1 of intravenous propofol until loss of consciousness, within 20 minutes. During infusion, the Modified Ramsay Scale will be used by the anesthetist in charge to measure the levels of consciousness, assessed 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. After this, the endoscopy procedure will continue normally following standard clinical protocols. Before leaving, patients will be asked to answer the BRICE survey, used to evaluate the patient's experience during surgery or similar procedures. Patients will be measured throughout the whole endoscopy procedure. Any additional considerations will be managed in a case-by-case manner by the medical staff in charge.
Justification of the chosen sample size The sample size (n = 25) was determined by the Cohen Test, with a statistical power of 0.8 and an alfa power of 0.05, to determine significant intraspecific subject differences when comparing wakefulness, deep sedation, and intermediate levels of consciousness.
EEG data analysis 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) power bands will be used as features for the decoding model. The features will be calculated using a moving window of one minute. The levels of consciousness identified using the Modified Ramsay Scale will be paired with the corresponding window. The software Homer 2012: MNE in Python will be used for these analyses.
fNIRS data analysis The temporal reference of the oxygenated (HbO2) and deoxygenated (HHb) hemoglobin will be obtained from the optical signals, using the modified Beer-Lambert law. The regions of interest (ROIs) will be obtained in relation to regional local average activity. The average, maximal, and slope of the signal of each ROI will be obtained. Vector-phase analyses will also be implemented, with one-minute windows. The software Homer 2021: MNE in Python will be used for these analyses.
Classification using machine-learning For each one-minute window, the EEG and fNIRS features will be given to a Support Vector Machine (SVM) classifier using a basal radius. Each window will be attached to the level of consciousness according to the Modified Ramsay Scale. Three models will be tested: only EEG, only fNIRS, and fNIRS + EEG. Each model will try to decode the patient's level of consciousness using the aforementioned scale.
- Conditions
- Anesthesia, Consciousness, Loss of
- Keywords
- Anesthesia, Consciousness, Endoscopy, fNIRS, Propofol, Parietal, Electroencephalography, Functional near-infrared spectroscopy, EEG, Machine learning
- Medical subject headings
- Unconsciousness
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 20 minutes
Secondary outcomes (1)
BRICE survey responses
Before leaving, patients will be asked to answer the BRICE survey, used to evaluate the patient's experience during surgery or similar procedures (Table 6. in Kotsovolis \& Komninos, 2009).
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start14 May 2022
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catalina Saini Ferrón, Pontificia Universidad Catolica de Chile
- Investigators
- Catalina A Saini, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112042
- Sponsor's protocol ID
- 210716001
- Status last verified
- Apr 2024
- First submitted
- 10 Oct 2021
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Department of Anesthesiology and the Institute of Biological and Medical Engineering (IIBM) of the Pontificia Universidad Católica de Chile, will take the necessary measurements to protect the access to your clinical information and sensible data from unauthorized people. All the obtained information will be kept confidential. The name, ID, or any other identifiable information, will be anonymized in a database. This information will be stored for five years under the responsibility of the corresponding researchers. The collected data will be published to be used in other studies related to anesthesia and consciousness. All published data will be completely anonymized. It is possible that the obtained results are presented in journals and medical or scientific conferences. However, the name and identifiable data will not be known.
Publications
Aru J, Suzuki M, Larkum ME. Cellular Mechanisms of Conscious Processing. Trends Cogn Sci. 2020 Oct;24(10):814-825. doi: 10.1016/j.tics.2020.07.006. Epub 2020 Aug 24.
PubMed 32855048Campbell 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.
PubMed 31672663Davidson 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.
PubMed 21466608Hirota 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.
PubMed 16634415Saadeh 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.
PubMed 31180871Kotsovolis G, Komninos G. Awareness during anesthesia: how sure can we be that the patient is sleeping indeed? Hippokratia. 2009 Apr;13(2):83-9.
PubMed 19561776Lee, 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
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.
PubMed 23872157Levitt 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.
PubMed 15847680Sheahan CG, Mathews DM. Monitoring and delivery of sedation. Br J Anaesth. 2014 Dec;113 Suppl 2:ii37-47. doi: 10.1093/bja/aeu378.
PubMed 25498581Sebel 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.
PubMed 15333419Sepulveda 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.
PubMed 31788791Sitaram 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.
PubMed 28003656Yeom 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.
PubMed 29121108Zimeo 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.
PubMed 29463928
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Classification of Levels of Consciousness Using Parietal EEG-fNIRS During Anesthesia
- ClinicalTrials.gov ID
- NCT05112042
- Acronym / sponsor ID
- 210716001
- Conditions
- Anesthesia, Consciousness, Loss of
- Keywords
- Anesthesia, Consciousness, Endoscopy, fNIRS, Propofol, Parietal, Electroencephalography, Functional near-infrared spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 14 May 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Devices for data acquisition The brain electrical signals will be measured with four electrodes and a Cyton OpenBCI board with a sampling frequency of 250 Hz. The brain hemodynamical signals will be measured with a NIRSport with 16 optodes and a sampling frequency of 15.525 Hz and a wavelength of 760 nm. The electrodes and optodes will be positioned in the parietal zone, following the recommended 10-5 system for the multimodal EEG-fNIRS paradigm. The software Lab Streaming Layer will be used to synchronize the EEG and fNIRS data.
Data acquisition Patients will be summoned 30 minutes before their clinical appointment to put, adjust and calibrate the EEG and fNIRS systems. A 5-minute baseline measurement will be performed before the endoscopy procedure, with eyes closed. Afterward, patients will be anesthetized with a constant infusion rate of 20 mg/kg/h-1 of intravenous propofol until loss of consciousness, within 20 minutes. During infusion, the Modified Ramsay Scale will be used by the anesthetist in charge to measure the levels of consciousness, assessed 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. After this, the endoscopy procedure will continue normally following standard clinical protocols. Before leaving, patients will be asked to answer the BRICE survey, used to evaluate the patient's experience during surgery or similar procedures. Patients will be measured throughout the whole endoscopy procedure. Any additional considerations will be managed in a case-by-case manner by the medical staff in charge.
Justification of the chosen sample size The sample size (n = 25) was determined by the Cohen Test, with a statistical power of 0.8 and an alfa power of 0.05, to determine significant intraspecific subject differences when comparing wakefulness, deep sedation, and intermediate levels of consciousness.
EEG data analysis 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) power bands will be used as features for the decoding model. The features will be calculated using a moving window of one minute. The levels of consciousness identified using the Modified Ramsay Scale will be paired with the corresponding window. The software Homer 2012: MNE in Python will be used for these analyses.
fNIRS data analysis The temporal reference of the oxygenated (HbO2) and deoxygenated (HHb) hemoglobin will be obtained from the optical signals, using the modified Beer-Lambert law. The regions of interest (ROIs) will be obtained in relation to regional local average activity. The average, maximal, and slope of the signal of each ROI will be obtained. Vector-phase analyses will also be implemented, with one-minute windows. The software Homer 2021: MNE in Python will be used for these analyses.
Classification using machine-learning For each one-minute window, the EEG and fNIRS features will be given to a Support Vector Machine (SVM) classifier using a basal radius. Each window will be attached to the level of consciousness according to the Modified Ramsay Scale. Three models will be tested: only EEG, only fNIRS, and fNIRS + EEG. Each model will try to decode the patient's level of consciousness using the aforementioned scale.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- ASA I or II
- Patients who will undergo an endoscopy procedure
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brain electrophysiological activity by electroencephalography wavelength band powers
Time frame: During the whole endoscopy and recovery (1 - 2 hours)
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.
Temporal brain oxygenation by near-infrared light spectroscopy wavelengths
Time frame: During the whole endoscopy and recovery (1 - 2 hours)
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.
Levels of Consciousness with the Modified Ramsay Sedation Scale
Time frame: 20 minutes
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.
1 secondary outcome
BRICE survey responses
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Background: PubMed 32855048Aru J, Suzuki M, Larkum ME. Cellular Mechanisms of Conscious Processing. Trends Cogn Sci. 2020 Oct;24(10):814-825. doi: 10.1016/j.tics.2020.07.006. Epub 2020 Aug 24.
- Background: PubMed 31672663Campbell 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.
- Background: PubMed 21466608Davidson 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.
- Background: PubMed 16634415Hirota 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.
- Background: PubMed 31180871Saadeh 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.
- Background: PubMed 19561776Kotsovolis G, Komninos G. Awareness during anesthesia: how sure can we be that the patient is sleeping indeed? Hippokratia. 2009 Apr;13(2):83-9.
- BackgroundLee, 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: PubMed 23872157Leon-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.
- Background: PubMed 15847680Levitt 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.
- Background: PubMed 25498581Sheahan CG, Mathews DM. Monitoring and delivery of sedation. Br J Anaesth. 2014 Dec;113 Suppl 2:ii37-47. doi: 10.1093/bja/aeu378.
- Background: PubMed 15333419Sebel 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.
- Background: PubMed 31788791Sepulveda 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.
- Kothe, C. (2014). Lab streaming layer (LSL)Link provided by the sponsor.
- Individual participant dataSharing planned: No. The Department of Anesthesiology and the Institute of Biological and Medical Engineering (IIBM) of the Pontificia Universidad Católica de Chile, will take the necessary measurements to protect the access to your clinical information and sensible data from unauthorized people. All the obtained information will be kept confidential. The name, ID, or any other identifiable information, will be anonymized in a database. This information will be stored for five years under the responsibility of the corresponding researchers. The collected data will be published to be used in other studies related to anesthesia and consciousness. All published data will be completely anonymized. It is possible that the obtained results are presented in journals and medical or scientific conferences. However, the name and identifiable data will not be known.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catalina A Saini principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Consciousness, Loss of, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain electrophysiological activity by electroencephalography wavelength band powers (time frame: During the whole endoscopy and recovery (1 - 2 hours)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05112042, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.