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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nurse's Role Bispectral Index Pediatric Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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BIS-Guided Nurse-Led Sedation Protocol

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.

Group Type EXPERIMENTAL

BIS-Guided Sedation Protocol

Intervention Type 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.

Standard Sedation Protocol

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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BIS-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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No