Bispectral Index, Nurse's Role, Pediatric Sedation
Conditions
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.
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.
Interventions
BEHAVIORALBIS-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.
Sponsors
Dr. Behcet Uz Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Two-arm, parallel-group, randomized controlled trial comparing a nurse-led BIS-guided sedation protocol with standard sedation management in mechanically ventilated pediatric patients.
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Spent Outside BIS Target Range | First 72 hours of mechanical ventilation | 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. |
| Cumulative Midazolam Dose | Up to 28 days or until extubation | otal midazolam dose administered (mg/kg) during mechanical ventilation. |
| Cumulative Ketamine Dose | Up to 28 days or until extubation | Total ketamine dose administered (mcg/kg) during mechanical ventilation. |
| Cumulative Dexmedetomidine Dose | Up to 28 days or until extubation | Total dexmedetomidine dose administered (mcg/kg) during mechanical ventilation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Withdrawal Severity (WAT-1 Score) | First 7 days of PICU stay | Mean and peak WAT-1 scores assessed to determine iatrogenic withdrawal severity. |
| PICU Length of Stay | Up to 28 days | Total number of days from PICU admission to PICU discharge. |
Countries
Turkey (Türkiye)
Outcome results
None listed