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

Dr. Behcet Uz Children's Hospital

Status: Completed

Conditions: Pediatric Sedation; Nurse's Role; Bispectral Index

Treatments: Behavioral: BIS-Guided Sedation Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT07252024

02024/GOA-92

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

BIS-Guided Nurse-Led Sedation Protocol

Experimental group

Description:

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.

Treatment:

Behavioral: BIS-Guided Sedation Protocol

Standard Sedation Protocol

No Intervention group

Description:

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.