BIS, Integrated Pulmonary Index, Pediatric, Pediatric Hematology, Sedation
Conditions
Brief summary
Pediatric hematologic procedures such as lumbar puncture and bone marrow aspiration often require deep sedation due to pain and the need for immobility. Sedative and opioid combinations increase the risk of respiratory depression. Integrated Pulmonary Index (IPI) combines SpO₂, EtCO₂, respiratory rate, and heart rate into a single score and may allow earlier detection of respiratory compromise. This study aims to evaluate the safety and effectiveness of IPI monitoring in pediatric patients undergoing hematologic procedures under sedation with BIS monitoring.
Interventions
PROCEDUREDeep Sedation with IPI and BIS Monitoring
Standard sedation protocol including Midazolam (0.03 mg/kg), Fentanyl (1 mcg/kg), and Propofol (1-2 mg/kg). Monitoring includes standard ASA monitors plus Bispectral Index (BIS) and Integrated Pulmonary Index (IPI).
Sponsors
Ankara City Hospital Bilkent
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing hematologic interventions (Bone Marrow ---Aspiration/Lumbar Puncture). * ASA Physical Status I-III. * Age 2-18 years.
Exclusion criteria
* Parental refusal. * ASA score ≥ 4. * Allergy to Propofol or Fentanyl. * Advanced organ failure (Heart, Kidney, Liver, Lung). * Intracranial mass, epilepsy, or neuromuscular disease. * History of Malignant Hyperthermia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Respiratory Adverse Events (Hypoxia and Apnea) | Measured pre-procedure (baseline), and at 0, 1, 3, 5, 10, 15, 20, 25, and 30 minutes after initiation of the procedure. | Evaluation of respiratory safety using standard monitoring versus Integrated Pulmonary Index (IPI). Apnea is defined as cessation of CO2 exhalation for 15 seconds. Hypoxia is defined as SpO2 ≤ 92% or an IPI score drop to ≤ 6. Interventions required (e.g., jaw thrust, oxygen increase) will be recorded. |
| Incidence of Respiratory Adverse Events (Apnea/Hypoxia) | Measured pre-procedure (baseline), and at 0, 1, 3, 5, 10, 15, 20, 25, and 30 minutes after initiation of the procedure. | Apnea is defined as cessation of CO2 exhalation for 15 seconds. Hypoxia is defined as SpO2 ≤ 92% or IPI ≤ 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Recovery | Immediately after the procedure until achievement of a Modified Aldrete Score >=8 | Time required for the patient to reach a Modified Aldrete Score of ≥8 (assessing respiration, O2 saturation, consciousness, circulation, and activity) ready for discharge from the recovery room. |
| Depth of Anesthesia | Measured pre-procedure (baseline), and at 0, 1, 3, 5, 10, 15, 20, 25, and 30 minutes after initiation of the procedure. | Assessment of anesthetic depth using Bispectral Index (BIS) monitoring to maintain adequate hypnosis during the procedure. |
| Anesthetic Drug Consumption | During the procedure, up to 30 minutes after initiation of the procedure | Total cumulative dose of Propofol (mg/kg) Total cumulative dose of Fentanyl (mcg/kg) |
| Hemodynamic and Respiratory Parameters | Measured pre-procedure (baseline), and at 0, 1, 3, 5, 10, 15, 20, 25, and 30 minutes after initiation of the procedure. | Intraoperative monitoring included: Systolic Blood Pressure (SBP) Diastolic Blood Pressure (DBP) Mean Arterial Pressure (MAP) Heart Rate (HR) Peripheral Oxygen Saturation (SpO₂) Respiratory Rate (RR) End-tidal Carbon Dioxide (EtCO₂) |
| Adverse Events | Periprocedurally, from induction of sedation until transfer to the hospital ward | Postoperative Nausea and Vomiting (PONV) Agitation Bronchospasm Laryngospasm |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORVILDAN ERGEN, MD
Ankara City Hospital Bilkent
Outcome results
None listed