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NCT07733544

Sedation Safety Assessment Using IPI Monitoring in Pediatric Hematologic Procedures

Sponsor: Ankara City Hospital Bilkent

View on ClinicalTrials.gov

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.

Official title: Evaluation of Sedation Safety Using Integrated Pulmonary Index (IPI) Monitoring During Pediatric Hematologic Procedures Performed Under BIS Monitoring

Key Details

Gender

All

Age Range

2 Years - 18 Years

Study Type

OBSERVATIONAL

Enrollment

80

Start Date

2026-04-01

Completion Date

2026-06-09

Last Updated

2026-07-29

Healthy Volunteers

No

Interventions

PROCEDURE

Deep 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).

Locations (1)

Ankara Bilkent Şehir Hastanesi

Ankara, Çankaya, Turkey (Türkiye)