Sedation ComplicationNCT05969483
Validation of a Processed EEG Device for Monitoring Sedation in PICU
An observational study of Sedation Complication, run by Azienda Ospedaliera di Padova at 1 site in Italy.
Trial summary
The goal of this prospective observational study is to validate pEEG as a monitoring tool for the analgosedation level in mechanically-ventilated critically ill children, receiving or not-receiving NMBAs. Read more about this study
- Who is it for?
- Ages 1 day to 18 years, women only
- Conditions the study is for
- Sedation Complication
- What is being tested?
- pEEG monitoring
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2022to 30 Sep 2026
- 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 1 day to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients admitted in PICU who undergone sedation and mechanical (invasive and non invasive) ventilation
Who may be able to join
- sedated and ventilated patients admitted in PICU
Who cannot join
- skin lesions
- significant traumatic lesions in the area where the Masimo Sedline® sensor need to be applied.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Processed EEG Device (pEEG, Masimo Sedline®) as a Monitoring Tool for the Analgosedation Level in Mechanically Ventilated Critically Ill Children
The goal of this prospective observational study is to validate pEEG as a monitoring tool for the analgosedation level in mechanically-ventilated critically ill children, receiving or not-receiving NMBAs. The main question aims to answer is to measure the strength of agreement between pEEG score and Comfort Behavioural Scale (CBS) (goal standard).
Participants will be monitored with pEEG and CBS evaluated during PICU admission. paralysis holiday) by a specialized PICU nurse and by a critical-care expert physician, blinded to each other.
Read the detailed description
Rationale: The existence of a strong agreement between the two scores will allow us to consider the use of Masimo Sedline® PSI in our routine practice as an additional tool to monitor the analgosedation level of mechanically ventilated critically ill patients, as well as the main tool for chemically paralyzed patients.The final goal of this project is to validate the Masimo Sedline® as a monitoring tool for the analgosedation level in mechanically-ventilated critically ill children, receiving or not-receiving NMBAs.
Specific Aim. To evaluate the strength of agreement between CBS and the Masimo Sedline® PSI in children.
Design: prospective cohort study including all consecutive mechanically ventilated patients receivinganalgosedation admitted to a tertiary-care PICU.
Setting: Tertiary-care Center PICU (Padova University Hospital, Italy). Partecipants: all consecutive patients who will receive mechanical ventilation and consequently analgosedation admitted to our PICU during the study period. Both patients receiving NMBAs and patient not receiving NMBAs will be included (patients with NMBA will be evaluated during a paralysis holiday). Exclusion criteria: patient with skin lesions or other significant traumatic lesions in the area where the Masimo Sedline® sensor need to be applied.
Exposure: All patients will be exposed to the Masimo Sedline® sensor. Its pEEG scores, including the PSI, will be registered by the patient primary nurse every 4 hours for the first 5 days of ventilation. At the same time, CBS will be evaluated by a specialized PICU nurse and by a critical-care expert physician, blinded to each other. In case of CBS discordance between the two operators, a mean will be used for data analysis. In case of chemically paralyzed patients, a paralysis holiday will be performed when clinically possible (ideally twice a day). A CBS will be assessed when the paralytic agents will be considered washed out, i.e. when the patient starts triggering at the ventilator and the EMG index starts showing muscular activity. The patient's analgosedation strategy and analgosedation protocol will not be standardized but will be decided by the treating physician based on the international recommendations.
Main outcome and measures: To evaluate the strength of agreement between the Masimo Sedline® PSI (exposure) and the CBS in mechanically in mechanically ventilated children, adequately or inadequately sedated, and in patients receiving NMBAs (during paralysis holiday).
Analytical plan: Descriptive statistics will be used to describe patients' demographic and clinical characteristics, as well as patient-related clinical outcomes. PSI and CBS will be tested for agreement using K statistics separately in patients with adequate sedation (CBS 11-22), inadequate sedation (CBS <11 or >22), and in patients receiving NMBAs. Multiple sensitivity analyses will be also performed in different subcohort of patients, including neonates, patients with seizures, as well as for different drugs. As an additional analysis, the use of a composite score including the EMG index (i.e. muscular activity) and the EEG suppression ratio (measure of EGG suppression events as index of oversedation) will be included.
- Conditions
- Sedation Complication
- Being tested
- pEEG monitoring
- Keywords
- sedation, pediatric intensive care, monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pEEG monitoringDevice
pEEG monitoring during PICU admission
| Study group | Role | What they receive |
|---|---|---|
| sedated and ventilated pediatric critical care patients | All sedated and ventilated critically ill patients will be exposed to the Masimo Sedline® sensor. Its pEEG scores, including the PSI, will be registered by the patient primary nurse every 4 hours for the first 5 days of ventilation. At the same time, CBS will be evaluated by a specialized PICU nurse and by a critical-care expert physician, blinded to each other. In case of chemically paralyzed patients, a paralysis holiday will be performed when clinically possible . A CBS will be assessed when the paralytic agents will be considered washed out. The patient's analgosedation strategy and analgosedation protocol will not be standardized but will be decided by the treating physician based on the international recommendations. Receives: Device: pEEG monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
agreement between PSI (exposure) and CBS scale the CBS
grade of agreement (Kappa of Cohen)
Measured: T1 (after 4 hours of ventilation)
agreement between PSI (exposure) and CBS scale
grade of agreement (Kappa of Cohen)
Measured: T1 (after 8 hours of ventilation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Oct 2022
- Primary completion28 Oct 2025
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sedation ComplicationStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, angela amigoni, Azienda Ospedaliera di Padova
- Investigators
- angela amigoni, MD, Principal investigator, University Hospital of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969483
- Sponsor's protocol ID
- AOP2549
- Status last verified
- Oct 2026
- First submitted
- 20 May 2023
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Harris J, Ramelet AS, van Dijk M, Pokorna P, Wielenga J, Tume L, Tibboel D, Ista E. Clinical recommendations for pain, sedation, withdrawal and delirium assessment in critically ill infants and children: an ESPNIC position statement for healthcare professionals. Intensive Care Med. 2016 Jun;42(6):972-86. doi: 10.1007/s00134-016-4344-1. Epub 2016 Apr 15.
PubMed 27084344Amigoni A, Mozzo E, Brugnaro L, Gentilomo C, Stritoni V, Michelin E, Pettenazzo A. Assessing sedation in a pediatric intensive care unit using Comfort Behavioural Scale and Bispectral Index: these tools are different. Minerva Anestesiol. 2012 Mar;78(3):322-9.
PubMed 22127309Twite MD, Zuk J, Gralla J, Friesen RH. Correlation of the Bispectral Index Monitor with the COMFORT scale in the pediatric intensive care unit. Pediatr Crit Care Med. 2005 Nov;6(6):648-53; quiz 654.
PubMed 16276329Tobias JD, Grindstaff R. Bispectral index monitoring during the administration of neuromuscular blocking agents in the pediatric intensive care unit patient. J Intensive Care Med. 2005 Jul-Aug;20(4):233-7. doi: 10.1177/0885066605276806.
PubMed 16061906Christenson C, Martinez-Vazquez P, Breidenstein M, Farhang B, Mathews J, Melia U, Jensen EW, Mathews D. Comparison of the Conox (qCON) and Sedline (PSI) depth of anaesthesia indices to predict the hypnotic effect during desflurane general anaesthesia with ketamine. J Clin Monit Comput. 2021 Dec;35(6):1421-1428. doi: 10.1007/s10877-020-00619-3. Epub 2020 Nov 19.
PubMed 33211251Ista E, van Dijk M, Tibboel D, de Hoog M. Assessment of sedation levels in pediatric intensive care patients can be improved by using the COMFORT "behavior" scale. Pediatr Crit Care Med. 2005 Jan;6(1):58-63. doi: 10.1097/01.PCC.0000149318.40279.1A.
PubMed 15636661Smith HAB, Besunder JB, Betters KA, Johnson PN, Srinivasan V, Stormorken A, Farrington E, Golianu B, Godshall AJ, Acinelli L, Almgren C, Bailey CH, Boyd JM, Cisco MJ, Damian M, deAlmeida ML, Fehr J, Fenton KE, Gilliland F, Grant MJC, Howell J, Ruggles CA, Simone S, Su F, Sullivan JE, Tegtmeyer K, Traube C, Williams S, Berkenbosch JW. 2022 Society of Critical Care Medicine Clinical Practice Guidelines on Prevention and Management of Pain, Agitation, Neuromuscular Blockade, and Delirium in Critically Ill Pediatric Patients With Consideration of the ICU Environment and Early Mobility. Pediatr Crit Care Med. 2022 Feb 1;23(2):e74-e110. doi: 10.1097/PCC.0000000000002873.
PubMed 35119438
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Processed EEG Device (pEEG, Masimo Sedline®) as a Monitoring Tool for the Analgosedation Level in Mechanically Ventilated Critically Ill Children
- ClinicalTrials.gov ID
- NCT05969483
- Acronym / sponsor ID
- AOP2549
- Conditions
- Sedation Complication
- Keywords
- sedation, pediatric intensive care, monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Azienda Ospedaliera di PadovaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 1 Aug 2023 (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 goal of this prospective observational study is to validate pEEG as a monitoring tool for the analgosedation level in mechanically-ventilated critically ill children, receiving or not-receiving NMBAs. The main question aims to answer is to measure the strength of agreement between pEEG score and Comfort Behavioural Scale (CBS) (goal standard).
Participants will be monitored with pEEG and CBS evaluated during PICU admission. paralysis holiday) by a specialized PICU nurse and by a critical-care expert physician, blinded to each other.
Detailed description
Rationale: The existence of a strong agreement between the two scores will allow us to consider the use of Masimo Sedline® PSI in our routine practice as an additional tool to monitor the analgosedation level of mechanically ventilated critically ill patients, as well as the main tool for chemically paralyzed patients.The final goal of this project is to validate the Masimo Sedline® as a monitoring tool for the analgosedation level in mechanically-ventilated critically ill children, receiving or not-receiving NMBAs.
Specific Aim. To evaluate the strength of agreement between CBS and the Masimo Sedline® PSI in children.
Design: prospective cohort study including all consecutive mechanically ventilated patients receivinganalgosedation admitted to a tertiary-care PICU.
Setting: Tertiary-care Center PICU (Padova University Hospital, Italy). Partecipants: all consecutive patients who will receive mechanical ventilation and consequently analgosedation admitted to our PICU during the study period. Both patients receiving NMBAs and patient not receiving NMBAs will be included (patients with NMBA will be evaluated during a paralysis holiday). Exclusion criteria: patient with skin lesions or other significant traumatic lesions in the area where the Masimo Sedline® sensor need to be applied.
Exposure: All patients will be exposed to the Masimo Sedline® sensor. Its pEEG scores, including the PSI, will be registered by the patient primary nurse every 4 hours for the first 5 days of ventilation. At the same time, CBS will be evaluated by a specialized PICU nurse and by a critical-care expert physician, blinded to each other. In case of CBS discordance between the two operators, a mean will be used for data analysis. In case of chemically paralyzed patients, a paralysis holiday will be performed when clinically possible (ideally twice a day). A CBS will be assessed when the paralytic agents will be considered washed out, i.e. when the patient starts triggering at the ventilator and the EMG index starts showing muscular activity. The patient's analgosedation strategy and analgosedation protocol will not be standardized but will be decided by the treating physician based on the international recommendations.
Main outcome and measures: To evaluate the strength of agreement between the Masimo Sedline® PSI (exposure) and the CBS in mechanically in mechanically ventilated children, adequately or inadequately sedated, and in patients receiving NMBAs (during paralysis holiday).
Analytical plan: Descriptive statistics will be used to describe patients' demographic and clinical characteristics, as well as patient-related clinical outcomes. PSI and CBS will be tested for agreement using K statistics separately in patients with adequate sedation (CBS 11-22), inadequate sedation (CBS <11 or >22), and in patients receiving NMBAs. Multiple sensitivity analyses will be also performed in different subcohort of patients, including neonates, patients with seizures, as well as for different drugs. As an additional analysis, the use of a composite score including the EMG index (i.e. muscular activity) and the EEG suppression ratio (measure of EGG suppression events as index of oversedation) will be included.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sedated and ventilated pediatric critical care patients | – | Device: pEEG monitoringAll sedated and ventilated critically ill patients will be exposed to the Masimo Sedline® sensor. Its pEEG scores, including the PSI, will be registered by the patient primary nurse every 4 hours for the first 5 days of ventilation. At the same time, CBS will be evaluated by a specialized PICU nurse and by a critical-care expert physician, blinded to each other. In case of chemically paralyzed patients, a paralysis holiday will be performed when clinically possible . A CBS will be assessed when the paralytic agents will be considered washed out. The patient's analgosedation strategy and analgosedation protocol will not be standardized but will be decided by the treating physician based on the international recommendations. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients admitted in PICU who undergone sedation and mechanical (invasive and non invasive) ventilation
Key inclusion criteria (1 listed)
- sedated and ventilated patients admitted in PICU
Key exclusion criteria (2 listed)
- skin lesions
- significant traumatic lesions in the area where the Masimo Sedline® sensor need to be applied.
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 |
|---|---|---|
| pEEG monitoringpEEG monitoring during PICU admission | Device | sedated and ventilated pediatric critical care patients |
Primary outcome
agreement between PSI (exposure) and CBS scale the CBS
Time frame: T1 (after 4 hours of ventilation)
grade of agreement (Kappa of Cohen)
agreement between PSI (exposure) and CBS scale
Time frame: T1 (after 8 hours of ventilation)
grade of agreement (Kappa of Cohen)
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 27 Oct 2026.
- Results publication: PubMed 27084344Harris J, Ramelet AS, van Dijk M, Pokorna P, Wielenga J, Tume L, Tibboel D, Ista E. Clinical recommendations for pain, sedation, withdrawal and delirium assessment in critically ill infants and children: an ESPNIC position statement for healthcare professionals. Intensive Care Med. 2016 Jun;42(6):972-86. doi: 10.1007/s00134-016-4344-1. Epub 2016 Apr 15.
- Results publication: PubMed 22127309Amigoni A, Mozzo E, Brugnaro L, Gentilomo C, Stritoni V, Michelin E, Pettenazzo A. Assessing sedation in a pediatric intensive care unit using Comfort Behavioural Scale and Bispectral Index: these tools are different. Minerva Anestesiol. 2012 Mar;78(3):322-9.
- Results publication: PubMed 16276329Twite MD, Zuk J, Gralla J, Friesen RH. Correlation of the Bispectral Index Monitor with the COMFORT scale in the pediatric intensive care unit. Pediatr Crit Care Med. 2005 Nov;6(6):648-53; quiz 654.
- Results publication: PubMed 16061906Tobias JD, Grindstaff R. Bispectral index monitoring during the administration of neuromuscular blocking agents in the pediatric intensive care unit patient. J Intensive Care Med. 2005 Jul-Aug;20(4):233-7. doi: 10.1177/0885066605276806.
- Results publication: PubMed 33211251Christenson C, Martinez-Vazquez P, Breidenstein M, Farhang B, Mathews J, Melia U, Jensen EW, Mathews D. Comparison of the Conox (qCON) and Sedline (PSI) depth of anaesthesia indices to predict the hypnotic effect during desflurane general anaesthesia with ketamine. J Clin Monit Comput. 2021 Dec;35(6):1421-1428. doi: 10.1007/s10877-020-00619-3. Epub 2020 Nov 19.
- Results publication: PubMed 15636661Ista E, van Dijk M, Tibboel D, de Hoog M. Assessment of sedation levels in pediatric intensive care patients can be improved by using the COMFORT "behavior" scale. Pediatr Crit Care Med. 2005 Jan;6(1):58-63. doi: 10.1097/01.PCC.0000149318.40279.1A.
- Results publication: PubMed 35119438Smith HAB, Besunder JB, Betters KA, Johnson PN, Srinivasan V, Stormorken A, Farrington E, Golianu B, Godshall AJ, Acinelli L, Almgren C, Bailey CH, Boyd JM, Cisco MJ, Damian M, deAlmeida ML, Fehr J, Fenton KE, Gilliland F, Grant MJC, Howell J, Ruggles CA, Simone S, Su F, Sullivan JE, Tegtmeyer K, Traube C, Williams S, Berkenbosch JW. 2022 Society of Critical Care Medicine Clinical Practice Guidelines on Prevention and Management of Pain, Agitation, Neuromuscular Blockade, and Delirium in Critically Ill Pediatric Patients With Consideration of the ICU Environment and Early Mobility. Pediatr Crit Care Med. 2022 Feb 1;23(2):e74-e110. doi: 10.1097/PCC.0000000000002873.
- Individual participant dataSharing planned: Undecided
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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.
angela amigoni, MD principal investigator
University Hospital of Padova
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 Sedation Complication, run by Azienda Ospedaliera di Padova 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 2 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 27 Oct 2026. 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?
agreement between PSI (exposure) and CBS scale the CBS (time frame: T1 (after 4 hours of ventilation)). 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?
On the ClinicalTrials.gov record for NCT05969483, which also lists 7 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 27 Oct 2026.