Nurse-Led BIS-Guided Sedation Protocol in Pediatric Intensive Care (NCT07252024) | Clinical Trial Compass
CompletedNot Applicable
Nurse-Led BIS-Guided Sedation Protocol in Pediatric Intensive Care
Turkey (Türkiye)88 participantsStarted 2024-06-01
Plain-language 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.
Who can participate
Age range
1 Month – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a nurse-led sedation protocol guided by a BIS monitor in pediatric ICU patients — if my child needs sedation in the ICU, is this kind of BIS-guided approach something your team already uses, or is it still being evaluated?
2The study tracked how much time children spent outside the target sedation range, as well as total doses of midazolam, ketamine, and dexmedetomidine — what does that mean for how you would decide if my child is getting too much or too little sedation?
3Since this trial has already been completed, have the results been published or shared, and do they suggest the nurse-led BIS protocol led to safer or more consistent sedation compared to standard care?
4The medications tracked in this trial — midazolam, ketamine, and dexmedetomidine — are all commonly used together in pediatric ICU sedation, so can you explain how you currently balance those three drugs and what side effects I should watch for?
5Given that this was a nurse-led protocol, how does your ICU team currently decide who adjusts sedation levels for a child, and would my child's care follow a similar structured approach?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time Spent Outside BIS Target Range
Timeframe: First 72 hours of mechanical ventilation