Nurse's RoleNCT07252024
Nurse-Led BIS-Guided Sedation Protocol in Pediatric Intensive Care
A study testing BIS-Guided Sedation Protocol in people with Nurse's Role and Bispectral Index, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Nurse's Role, Bispectral Index, Pediatric Sedation
- What is being tested?
- BIS-Guided Sedation Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Behcet Uz Children's Hospital - Pediatric Intensive Care Unit
Izmir
About this study
Official title: Nurse-Led Bispectral Index (BIS)-Guided Sedation Protocol and Its Impact on Clinical Outcomes in Mechanically Ventilated Pediatric Intensive Care Patients: A Prospective, Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Nurse's Role, Bispectral Index, Pediatric Sedation
- Being tested
- BIS-Guided Sedation Protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS-Guided Sedation ProtocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: BIS-Guided Sedation Protocol |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First 72 hours of mechanical ventilation
Cumulative Midazolam Dose
otal midazolam dose administered (mg/kg) during mechanical ventilation.
Measured: Up to 28 days or until extubation
Cumulative Ketamine Dose
Total ketamine dose administered (mcg/kg) during mechanical ventilation.
Measured: Up to 28 days or until extubation
Cumulative Dexmedetomidine Dose
Total dexmedetomidine dose administered (mcg/kg) during mechanical ventilation.
Measured: Up to 28 days or until extubation
Secondary outcomes (2)
Withdrawal Severity (WAT-1 Score)
Mean and peak WAT-1 scores assessed to determine iatrogenic withdrawal severity.
Measured: First 7 days of PICU stay
PICU Length of Stay
Total number of days from PICU admission to PICU discharge.
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Jun 2024
- Primary completion1 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Behcet Uz Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan ağın, Dr. Behcet Uz Children's Hospital
- Investigators
- Hasan Agin, Prof.Dr., Principal investigator, Dr. Behcet Uz Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252024
- Sponsor's protocol ID
- 02024/GOA-92
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient privacy and institutional policy.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-Led Bispectral Index (BIS)-Guided Sedation Protocol and Its Impact on Clinical Outcomes in Mechanically Ventilated Pediatric Intensive Care Patients: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07252024
- Acronym / sponsor ID
- 02024/GOA-92
- Conditions
- Nurse's Role, Bispectral Index, Pediatric Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Dr. Behcet Uz Children's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| BIS-Guided Nurse-Led Sedation Protocol | Experimental | Behavioral: BIS-Guided Sedation ProtocolPatients 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. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIS-Guided Sedation ProtocolA 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. | Behavioural | BIS-Guided Nurse-Led Sedation Protocol |
Primary outcome
Time Spent Outside BIS Target Range
Time frame: 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
Time frame: Up to 28 days or until extubation
otal midazolam dose administered (mg/kg) during mechanical ventilation.
Cumulative Ketamine Dose
Time frame: Up to 28 days or until extubation
Total ketamine dose administered (mcg/kg) during mechanical ventilation.
Cumulative Dexmedetomidine Dose
Time frame: Up to 28 days or until extubation
Total dexmedetomidine dose administered (mcg/kg) during mechanical ventilation.
2 secondary outcomes
Withdrawal Severity (WAT-1 Score)
Time frame: First 7 days of PICU stay
PICU Length of Stay
Time frame: Up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient privacy and institutional policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hasan Agin, Prof.Dr. principal investigator
Dr. Behcet Uz Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIS-Guided Sedation Protocol in people with Nurse's Role and Bispectral Index, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Spent Outside BIS Target Range (time frame: First 72 hours of mechanical ventilation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.