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.

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.

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