Validation of a Processed EEG Device for Monitoring Sedation in PICU

Sedation Complication Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05969483
• Other study ID #: AOP2549
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Azienda Ospedaliera di Padova
• Contact: angela amigoni, MD
• Phone: +39 339 8333765
• Email: angela.amigoni[@]aopd.veneto.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 1 Day to 18 Years

Eligibility

Inclusion Criteria:

• sedated and ventilated patients admitted in PICU

Exclusion Criteria:

• skin lesions

• significant traumatic lesions in the area where the Masimo Sedline® sensor need to be applied.

Related Conditions & MeSH terms

• Sedation Complication

Intervention

Device:
• pEEG monitoring
pEEG monitoring during PICU admission

Locations

Country	Name	City	State
Italy	University Hospital of Padova	Padova

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Padova

Country where clinical trial is conducted

Italy, 

References & Publications (7)

Amigoni 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):32 — View Citation

Christenson 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 — View Citation

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 profess — View Citation

Ista 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. — View Citation

Smith 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, — View Citation

Tobias 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. — View Citation

Twite 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	agreement between PSI (exposure) and CBS scale the CBS	grade of agreement (Kappa of Cohen)	T1 (after 4 hours of ventilation)
Primary	agreement between PSI (exposure) and CBS scale	grade of agreement (Kappa of Cohen)	T1 (after 8 hours of ventilation)