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.
Study Type
OBSERVATIONAL
Enrollment
80
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).
Ankara Bilkent Şehir Hastanesi
Ankara, Çankaya, Turkey (Türkiye)
Incidence of Respiratory Adverse Events (Hypoxia and Apnea)
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.
Time frame: Measured pre-procedure (baseline), and at 0, 1, 3, 5, 10, 15, 20, 25, and 30 minutes after initiation of the procedure.
Incidence of Respiratory Adverse Events (Apnea/Hypoxia)
Apnea is defined as cessation of CO2 exhalation for 15 seconds. Hypoxia is defined as SpO2 ≤ 92% or IPI ≤ 6
Time frame: Measured pre-procedure (baseline), and at 0, 1, 3, 5, 10, 15, 20, 25, and 30 minutes after initiation of the procedure.
Time to Recovery
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.
Time frame: Immediately after the procedure until achievement of a Modified Aldrete Score >=8
Depth of Anesthesia
Assessment of anesthetic depth using Bispectral Index (BIS) monitoring to maintain adequate hypnosis during the procedure.
Time frame: Measured pre-procedure (baseline), and at 0, 1, 3, 5, 10, 15, 20, 25, and 30 minutes after initiation of the procedure.
Anesthetic Drug Consumption
Total cumulative dose of Propofol (mg/kg) Total cumulative dose of Fentanyl (mcg/kg)
Time frame: During the procedure, up to 30 minutes after initiation of the procedure
Hemodynamic and Respiratory Parameters
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)
Time frame: Measured pre-procedure (baseline), and at 0, 1, 3, 5, 10, 15, 20, 25, and 30 minutes after initiation of the procedure.
Adverse Events
Postoperative Nausea and Vomiting (PONV) Agitation Bronchospasm Laryngospasm
Time frame: Periprocedurally, from induction of sedation until transfer to the hospital ward
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