AnesthesiaNCT02240368
Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery
An observational study of Anesthesia and Child, run by University of Foggia at 1 site in Italy.
Trial summary
The purpose of this study is to determine how Bispectral index (BIS) and Entropy EEG monitors agree between themselves and with end-tidal concentration of sevoflurane (ETsevo) in relationship with the age in the pediatric surgery setting. Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Anesthesia, Child
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2014to Dec 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 month to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients with age ≤ 12 years old scheduled to undergo general anesthesia and mechanical ventilation for elective surgery
Who may be able to join
- physical status classification (ASA) I - II
- general balanced anesthesia
- mechanically ventilated with laryngeal mask
Who cannot join
- severe developmental delay
- neurological disorders or receiving treatment with antiepileptic or stimulant
- patients with preexisting lung or cardiac disease
- airway abnormalities
- marked skin sensitivity and conditions where the placement of the BIS and Entropy sensor or process of assessment would interfere with the surgery procedure.
- patients receiving local anaesthesia, regional block combined with general anaesthesia
- sedation administered by non anesthesiologists for invasive and noninvasive diagnostic or therapeutic procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery. Bispectral VISTA and ENTROPY Monitor for Pediatric Anesthesia.
The purpose of this study is to determine how Bispectral index (BIS) and Entropy EEG monitors agree between themselves and with end-tidal concentration of sevoflurane (ETsevo) in relationship with the age in the pediatric surgery setting.
Bispectral index (BIS) and Entropy EEG monitors performance and utility is well established in adult general anesthesia.
Their utility is yet undefined in the pediatric population as age seems to affect their ability to track the cerebral hypnotic state in children.
Read the detailed description
All patients monitored applying standard device for blood pressure, electrocardiogram and pulse oximeter for routine monitor of anesthesia in pediatric surgery. Bispectral VISTA monitor and Entropy monitor applied for monitoring the depth of anesthesia. The investigators will not assign any specific interventions to the subjects of the study.
- Conditions
- Anesthesia, Child
- Keywords
- Depth anesthesia monitors, Children anesthesia, Bispectral monitor, Entropy monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Children age between 1 month to 12 months | |
| Group 2 | Children age between 13 months and 36 months | |
| Group 3 | Children age between 37 months to 144 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
BISPECTRAL Index
The collected values of bispectral index and end tidal sevofluorane will generate a single prediction probability (PK) of agreement between bispectral index vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.
Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.
Measured: BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours
Entropy
The collected values of Entropy will generate a single prediction probability (PK) of agreement between Entropy vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.
Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.
Measured: Entropy values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours
Secondary outcomes (2)
BISPECTRAL Index Awaking
In each patient the Bispectral index values at the moment of first signs of awakening.The Bispectral index monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A BIS value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer
Measured: reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia
Entropy Awaking
In each patient the Entropy values at the moment of first signs of awakening. The Entropy monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A Entropy value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer
Measured: reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Principal investigator, Alberto Sciusco, University of Foggia
- Investigators
- Michele Dambrosio, Medic, Study chair, University of FoggiaGilda Cinnella, Medic, Study director, University of FoggiaAlberto Sciusco, medic, Principal investigator, University of FoggiaPasquale Raimondo, Medic, Principal investigator, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240368
- Sponsor's protocol ID
- A01
- Status last verified
- Jul 2018
- First submitted
- 31 Aug 2014
- Last updated
- 14 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery. Bispectral VISTA and ENTROPY Monitor for Pediatric Anesthesia.
- ClinicalTrials.gov ID
- NCT02240368
- Acronym / sponsor ID
- A01
- Conditions
- Anesthesia, Child
- Keywords
- Depth anesthesia monitors, Children anesthesia, Bispectral monitor, Entropy monitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Sep 2014 (estimated)
- Results
- Posted 9 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine how Bispectral index (BIS) and Entropy EEG monitors agree between themselves and with end-tidal concentration of sevoflurane (ETsevo) in relationship with the age in the pediatric surgery setting.
Bispectral index (BIS) and Entropy EEG monitors performance and utility is well established in adult general anesthesia.
Their utility is yet undefined in the pediatric population as age seems to affect their ability to track the cerebral hypnotic state in children.
Detailed description
All patients monitored applying standard device for blood pressure, electrocardiogram and pulse oximeter for routine monitor of anesthesia in pediatric surgery. Bispectral VISTA monitor and Entropy monitor applied for monitoring the depth of anesthesia. The investigators will not assign any specific interventions to the subjects of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Children age between 1 month to 12 months |
| Group 2 | – | –Children age between 13 months and 36 months |
| Group 3 | – | –Children age between 37 months to 144 months |
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients with age ≤ 12 years old scheduled to undergo general anesthesia and mechanical ventilation for elective surgery
Key inclusion criteria (3 listed)
- physical status classification (ASA) I - II
- general balanced anesthesia
- mechanically ventilated with laryngeal mask
Key exclusion criteria (7 listed)
- severe developmental delay
- neurological disorders or receiving treatment with antiepileptic or stimulant
- patients with preexisting lung or cardiac disease
- airway abnormalities
- marked skin sensitivity and conditions where the placement of the BIS and Entropy sensor or process of assessment would interfere with the surgery procedure.
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
BISPECTRAL Index
Time frame: BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours
The collected values of bispectral index and end tidal sevofluorane will generate a single prediction probability (PK) of agreement between bispectral index vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group. Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.
Entropy
Time frame: Entropy values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours
The collected values of Entropy will generate a single prediction probability (PK) of agreement between Entropy vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group. Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.
2 secondary outcomes
BISPECTRAL Index Awaking
Time frame: reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia
Entropy Awaking
Time frame: reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Speciality school of anesthesia of University of FoggiaLink provided by the sponsor.
- University of FoggiaLink provided by the sponsor.
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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.
Michele Dambrosio, Medic study chair
University of Foggia
Gilda Cinnella, Medic study director
University of Foggia
Alberto Sciusco, medic principal investigator
University of Foggia
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 Child, run by University of Foggia 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 3 inclusion and 7 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 14 Aug 2018. 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?
Yes. Results are posted in the registry (first posted 9 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
BISPECTRAL Index (time frame: BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2018.