Validation of a Processed EEG Device for Monitoring Sedation in PICU

NCT05969483 | Recruiting FDA Device

• 1 other identifier: AOP2549
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sedation Complication

Keywords

sedation; pediatric intensive care; monitoring

Outcome Measures

Primary Outcomes (2)

• agreement between PSI (exposure) and CBS scale the CBS

  grade of agreement (Kappa of Cohen)

  T1 (after 4 hours of ventilation)

• agreement between PSI (exposure) and CBS scale

  grade of agreement (Kappa of Cohen)

  T1 (after 8 hours of ventilation)

Study Arms (1)

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.

Device: pEEG monitoring

Interventions

pEEG monitoring DEVICE

pEEG monitoring during PICU admission

sedated and ventilated pediatric critical care patients

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pediatric patients admitted in PICU who undergone sedation and mechanical (invasive and non invasive) ventilation

You may qualify if:

• \- sedated and ventilated patients admitted in PICU

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliera di Padova: lead

Study Sites (1)

University Hospital of Padova

Padua, 35128, Italy

RECRUITING

Related Publications (7)

• 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.

  PMID: 27084344 RESULT

• 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):322-9.

  PMID: 22127309 RESULT

• 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.

  PMID: 16276329 RESULT

• 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.

  PMID: 16061906 RESULT

• 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 ketamine. J Clin Monit Comput. 2021 Dec;35(6):1421-1428. doi: 10.1007/s10877-020-00619-3. Epub 2020 Nov 19.

  PMID: 33211251 RESULT

• 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.

  PMID: 15636661 RESULT

• 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, 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.

  PMID: 35119438 RESULT

Study Officials

• angela amigoni, MD

  University Hospital of Padova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

angela amigoni, MD

CONTACT

+39 339 8333765; angela.amigoni@aopd.veneto.it

anna tessari

CONTACT

+ 39 3497804876; anna.tessari@aopd.veneto.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 20, 2023
• First Posted: August 1, 2023
• Study Start: October 1, 2022
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

IT (1)