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

NCT07252024 | Completed

• 1 other identifier: 02024/GOA-92
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nurse's Role; Bispectral Index; Pediatric Sedation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Withdrawal Severity (WAT-1 Score)

  First 7 days of PICU stay

• PICU Length of Stay

  Up to 28 days

Study Arms (2)

BIS-Guided Nurse-Led Sedation Protocol

EXPERIMENTAL

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

Standard Sedation Protocol

NO INTERVENTION

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.

Interventions

BIS-Guided Sedation Protocol BEHAVIORAL

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.

BIS-Guided Nurse-Led Sedation Protocol

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Behcet Uz Children's Hospital: lead

Study Sites (1)

Behcet Uz Children's Hospital - Pediatric Intensive Care Unit

Izmir, Turkey (Türkiye)

Location

Study Officials

• Hasan Agin, Prof.Dr.

  Dr. Behcet Uz Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr

Model Details: Two-arm, parallel-group, randomized controlled trial comparing a nurse-led BIS-guided sedation protocol with standard sedation management in mechanically ventilated pediatric patients.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 26, 2025
• Study Start: June 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)