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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hasan Agin, Prof.Dr. | Dr. Behcet Uz Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Behcet Uz Children's Hospital - Pediatric Intensive Care Unit | Izmir | Turkey (Türkiye) |
Individual participant data will not be shared due to patient privacy and institutional policy.
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Two-arm, parallel-group, randomized controlled trial comparing a nurse-led BIS-guided sedation protocol with standard sedation management in mechanically ventilated pediatric patients.
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| Up to 28 days |