Nurse-Led BIS-Guided Sedation Protocol in Pediatric Intensive Care

Nurse-Led Bispectral Index (BIS)-Guided Sedation Protocol and Its Impact on Clinical Outcomes in Mechanically Ventilated Pediatric Intensive Care Patients: A Prospective, Randomized Controlled Trial

Pediatric intensive care sedation is traditionally based on subjective clinical scales. Bispectral Index (BIS) monitoring provides an objective EEG-based assessment of sedation depth. This prospective, two-center randomized controlled trial evaluates whether a nurse-led BIS-guided sedation protocol can reduce excessive or inadequate sedation, sedative medication exposure, withdrawal symptoms, and PICU length of stay in mechanically ventilated children.

Study Overview

• Status: Completed
• Conditions: Nurse's Role; Bispectral Index; Pediatric Sedation
• Intervention / Treatment: Behavioral: BIS-Guided Sedation Protocol

Detailed Description

This prospective, randomized (1:1) controlled trial was conducted in two tertiary PICUs in Turkey, including mechanically ventilated children aged 1 month to 18 years requiring continuous sedation. Patients were randomly assigned to:

Intervention Group: Nurse-led sedation titration using BIS values (target: light sedation 60-80, deep sedation 45-60) combined with SBS scores under physician supervision. Nurses received structured theoretical and practical training before trial initiation.

Control Group: Standard sedation protocol based solely on clinical sedation assessment without BIS-guided titration (BIS monitoring available but not used for titration).

Primary Outcome:

Percentage and duration of time spent outside the target BIS range

Total sedative medication dose (mg/kg/day equivalents)

Secondary Outcomes:

PICU length of stay

Mechanical ventilation duration

Withdrawal symptoms (WAT-1 score)

Results showed significantly reduced BIS out-of-target time, lower sedative drug exposure (midazolam, ketamine, dexmedetomidine), reduced withdrawal scores, and shorter PICU stay in the intervention group.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Izmir, Turkey (Türkiye)
    • Behcet Uz Children's Hospital - Pediatric Intensive Care Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 1 month and 18 years
• Receiving invasive mechanical ventilation
• Expected to require sedation for ≥24 hours
• Hemodynamically stable at enrollment
• BIS monitoring electrode placement feasible

Exclusion Criteria:

• Use of neuromuscular blocking agents at enrollment
• Mechanical ventilation expected to last <24 hours
• Severe hemodynamic instability requiring escalating vasoactive support
• Known neurological disorders that prevent reliable BIS interpretation (e.g., severe encephalopathy, epileptic burst suppression)
• Facial burns or skin conditions preventing BIS electrode placement
• Decision for palliative/comfort care only

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIS-Guided Nurse-Led Sedation Protocol; Patients in this arm will receive sedation management guided by a nurse-led protocol using Bispectral Index (BIS) monitoring. Nurses titrate sedative medications according to BIS targets (light sedation: 60-80; deep sedation: 45-60) and Sedation Behavioral Scale (SBS) scores, under physician supervision. The protocol includes standardized electrode placement, artifact management, and stepwise titration of midazolam, ketamine, dexmedetomidine, or fentanyl according to predefined algorithms.	Behavioral: BIS-Guided Sedation Protocol; A structured sedation management protocol guided by Bispectral Index (BIS) monitoring and implemented by trained PICU nurses. The protocol includes BIS target ranges (light sedation 60-80; deep sedation 45-60), artifact recognition, standardized electrode placement, and stepwise titration of midazolam, ketamine, dexmedetomidine, or fentanyl according to predefined algorithms under physician supervision.
No Intervention: Standard Sedation Protocol; Patients in this arm receive routine sedation management according to the existing standard sedation protocol. Clinicians titrate sedative medications based on clinical assessment and SBS scores without using BIS-guided titration. BIS monitoring is available but not used for sedation adjustment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Spent Outside BIS Target Range	otal duration (in hours) during which BIS values remain outside the predefined sedation targets (light sedation: 60-80; deep sedation: 45-60). This measure reflects adequacy of sedation and protocol effectiveness.	First 72 hours of mechanical ventilation
Cumulative Midazolam Dose	otal midazolam dose administered (mg/kg) during mechanical ventilation.	Up to 28 days or until extubation
Cumulative Ketamine Dose	Total ketamine dose administered (mcg/kg) during mechanical ventilation.	Up to 28 days or until extubation
Cumulative Dexmedetomidine Dose	Total dexmedetomidine dose administered (mcg/kg) during mechanical ventilation.	Up to 28 days or until extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Withdrawal Severity (WAT-1 Score)	Mean and peak WAT-1 scores assessed to determine iatrogenic withdrawal severity.	First 7 days of PICU stay
PICU Length of Stay	Total number of days from PICU admission to PICU discharge.	Up to 28 days

Collaborators and Investigators

• Sponsor: Dr. Behcet Uz Children's Hospital
• Investigators: Principal Investigator: Hasan Agin, Prof.Dr., Dr. Behcet Uz Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): July 1, 2025
• Study Completion (Actual): August 1, 2025

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 02024/GOA-92

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to patient privacy and institutional policy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No