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Completed
NCT07733544
Sedation Safety Assessment Using IPI Monitoring in Pediatric Hematologic Procedures
Conditions: Sedation, Pediatric, Integrated Pulmonary Index, BIS, Pediatric Hematology
Sex: All
Ages: 2 Years – 18 Years
Healthy volunteers: No
Enrollment: 80
Sponsor: Ankara City Hospital Bilkent
Location: Ankara Bilkent Şehir Hastanesi Ankara Çankaya
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07733544). StuddyBuddy aggregates publicly available trial information.
