Evaluation of Sedation Safety Using Integrated Pulmonary Index (IPI) Monitoring During Pediatric Hematologic Procedures Performed Under BIS Monitoring
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ankara City Hospital Bilkent
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Incidence of Respiratory Adverse Events (Hypoxia and Apnea)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 2 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts 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 ≥
- •Allergy to Propofol or Fentanyl.
- •Advanced organ failure (Heart, Kidney, Liver, Lung).
- •Intracranial mass, epilepsy, or neuromuscular disease.
- •History of Malignant Hyperthermia
Outcomes
Primary Outcomes
Incidence of Respiratory Adverse Events (Hypoxia and Apnea)
Time Frame: 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)
Time Frame: 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 Outcomes
- Time to Recovery(Immediately after the procedure until achievement of a Modified Aldrete Score >=8)
- 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.)
- Anesthetic Drug Consumption(During the procedure, up to 30 minutes after initiation of the procedure)
- 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.)
- Adverse Events(Periprocedurally, from induction of sedation until transfer to the hospital ward)
Investigators
Vildan Ergen
Principal Investigator
Ankara City Hospital Bilkent