Anesthesia; Adverse EffectNCT05584904
A Single Dry EEG Electrode Allows to Estimate of the Level of Anesthesia During Colonoscopy Sedation.
An observational study of Anesthesia; Adverse Effect, run by Azienda USL Toscana Nord Ovest at 1 site in Italy.
Trial summary
We asked to a staff of digestive endoscopy and of the operating room to interpret the EEG traces obtained from a single dry electrode device to estimate the level of anesthesia during colonoscopy. They are required to produce a rank value (1 to 3) proportional to the anesthesia level. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Anesthesia; Adverse Effect
- What is being tested?
- volunteer anesthesiologists and nurses
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jan 2023to 20 Jan 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 25 to 65 years
- All sexes
- Adult, Older adult
Study population: All the anesthesiologists and nursing staff of the digestive endoscopy and operating room of the Volterra Hospital
Who may be able to join
- anesthesiologists and nursing staff of the operating room
Who cannot join
- specific knowledge of electroencephalography
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Short Segment of a Single Dry EEG Electrode Allows the Digestive Endoscopy and Operating Theater Staff the Estimation of the Level of Anesthesia During Colonoscopy Sedation
We asked to a staff of digestive endoscopy and of the operating room to interpret the EEG traces obtained from a single dry electrode device to estimate the level of anesthesia during colonoscopy. They are required to produce a rank value (1 to 3) proportional to the anesthesia level. The rank values of anesthesia evaluated through the EEG traces will be correlated to the typically used "bispectral index" values simultaneously acquired. The expected efficacy of a low-cost single dry-electrode EEG would allow the monitoring of the level of anesthesia during non operating room procedures such as colonoscopy.
Read the detailed description
Monitoring of the level of anesthesia has two primary functions: to reduce the incidence of awareness during operation and to avoid too deep anesthesia that is associated with increased risks of mortality and postoperative cognitive impairment. This monitoring can be performed by processed EEG such as "Bispectral Index" that provides a simple interpretation numerical value proportional to the anesthesia level. Nevertheless, "Bispectral index" requires specific tools and disposable material that increases costs for non operating room procedure. Colonoscopy is a non operating room procedure typically performed without or with light sedation, less frequently requires deep sedation. The latter is performed by using Propofol a drug that has a low therapeutic index and might be associated with adverse effects such as respiratory depression, aspiration related to loss of airway reflexes and hypotension. The aim of the present study is to evaluate the reliable interpretation of the raw EEG traces by a staff of digestive endoscopy and operating room for monitoring the level of sedation during non operative room anesthesia to avoid adverse effects.
- Conditions
- Anesthesia; Adverse Effect
- Being tested
- volunteer anesthesiologists and nurses
- Keywords
- raw EEG, colonoscopy sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
volunteer anesthesiologists and nursesOther
18 not expert in electroencephalography digestive endoscopy and operating room nurses, and 8 anesthesiologists interpreting EEGs obtained with a single electrode EEG
What is being measured
The primary outcome is the main question the study is designed to answer.
Single dry channel EEG for the monitoring of the level of anesthesia in non-operating room.
A staff of digestive endoscopy and operating room after attending a brief course of EEG specifically direct to anesthesia level interpretation, were asked to classify the raw EEG trace obtained with a sigle dry electrode device in 3 levels (1 to 3) according to the following category:
1 deep sedation, , 2 intermediate state, 3 light sedation or awake according to the BIS level and and coherent with clinical conditions.
We correlate staff scores produced by classifing the EEG trace with the number automatically and simultaneously produced by the "bispectral index" tool for the measurement of the level of anesthesia.
The reliability of raw single dry electrode EEG trace, might allow to assist low-cost device for non operating room anesthesia such as for colonoscopy sedation.
Measured: two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start13 Jan 2023
- Primary completion18 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia; Adverse EffectStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Other
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Toscana Nord Ovest
- Sponsor type
- University, hospital or other
- Collaborators
- Auxilium Vitae Volterra
- Responsible party
- Principal investigator, Alessandro Tani, Azienda USL Toscana Nord Ovest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584904
- Sponsor's protocol ID
- AUSLNordOvest
- Status last verified
- Feb 2023
- First submitted
- 14 Oct 2022
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the modalities of this option have not yet been decided
Publications
Barnard JP, Bennett C, Voss LJ, Sleigh JW. Can anaesthetists be taught to interpret the effects of general anaesthesia on the electroencephalogram? Comparison of performance with the BIS and spectral entropy. Br J Anaesth. 2007 Oct;99(4):532-7. doi: 10.1093/bja/aem198. Epub 2007 Jul 24.
PubMed 17652076
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Short Segment of a Single Dry EEG Electrode Allows the Digestive Endoscopy and Operating Theater Staff the Estimation of the Level of Anesthesia During Colonoscopy Sedation
- ClinicalTrials.gov ID
- NCT05584904
- Acronym / sponsor ID
- AUSLNordOvest
- Conditions
- Anesthesia; Adverse Effect
- Keywords
- raw EEG, colonoscopy sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Azienda USL Toscana Nord OvestUniversity, hospital or other
- Collaborators
- Auxilium Vitae Volterra
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 18 Oct 2022 (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.
We asked to a staff of digestive endoscopy and of the operating room to interpret the EEG traces obtained from a single dry electrode device to estimate the level of anesthesia during colonoscopy. They are required to produce a rank value (1 to 3) proportional to the anesthesia level. The rank values of anesthesia evaluated through the EEG traces will be correlated to the typically used "bispectral index" values simultaneously acquired. The expected efficacy of a low-cost single dry-electrode EEG would allow the monitoring of the level of anesthesia during non operating room procedures such as colonoscopy.
Detailed description
Monitoring of the level of anesthesia has two primary functions: to reduce the incidence of awareness during operation and to avoid too deep anesthesia that is associated with increased risks of mortality and postoperative cognitive impairment. This monitoring can be performed by processed EEG such as "Bispectral Index" that provides a simple interpretation numerical value proportional to the anesthesia level. Nevertheless, "Bispectral index" requires specific tools and disposable material that increases costs for non operating room procedure. Colonoscopy is a non operating room procedure typically performed without or with light sedation, less frequently requires deep sedation. The latter is performed by using Propofol a drug that has a low therapeutic index and might be associated with adverse effects such as respiratory depression, aspiration related to loss of airway reflexes and hypotension. The aim of the present study is to evaluate the reliable interpretation of the raw EEG traces by a staff of digestive endoscopy and operating room for monitoring the level of sedation during non operative room anesthesia to avoid adverse effects.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All the anesthesiologists and nursing staff of the digestive endoscopy and operating room of the Volterra Hospital
Key inclusion criteria (1 listed)
- anesthesiologists and nursing staff of the operating room
Key exclusion criteria (1 listed)
- specific knowledge of electroencephalography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| volunteer anesthesiologists and nurses18 not expert in electroencephalography digestive endoscopy and operating room nurses, and 8 anesthesiologists interpreting EEGs obtained with a single electrode EEG | Other | – |
Primary outcome
Single dry channel EEG for the monitoring of the level of anesthesia in non-operating room.
Time frame: two hours
A staff of digestive endoscopy and operating room after attending a brief course of EEG specifically direct to anesthesia level interpretation, were asked to classify the raw EEG trace obtained with a sigle dry electrode device in 3 levels (1 to 3) according to the following category: 1 deep sedation, , 2 intermediate state, 3 light sedation or awake according to the BIS level and and coherent with clinical conditions. We correlate staff scores produced by classifing the EEG trace with the number automatically and simultaneously produced by the "bispectral index" tool for the measurement of the level of anesthesia. The reliability of raw single dry electrode EEG trace, might allow to assist low-cost device for non operating room anesthesia such as for colonoscopy sedation.
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 16 Feb 2023.
- Background: PubMed 17652076Barnard JP, Bennett C, Voss LJ, Sleigh JW. Can anaesthetists be taught to interpret the effects of general anaesthesia on the electroencephalogram? Comparison of performance with the BIS and spectral entropy. Br J Anaesth. 2007 Oct;99(4):532-7. doi: 10.1093/bja/aem198. Epub 2007 Jul 24.
- Individual participant dataSharing planned: No. the modalities of this option have not yet been decided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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; Adverse Effect, run by Azienda USL Toscana Nord Ovest at 1 site in Italy.
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 1 inclusion and 1 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 16 Feb 2023. 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 Italy. 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?
Single dry channel EEG for the monitoring of the level of anesthesia in non-operating room. (time frame: two hours). 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 NCT05584904, which also lists 1 linked publication.
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 16 Feb 2023.