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Sedation Safety Assessment Using IPI Monitoring in Pediatric Hematologic Procedures

NCT07733544 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2026-07-29

No results posted yet for this study

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.

Conditions

  • Sedation
  • Pediatric
  • Integrated Pulmonary Index
  • BIS
  • Pediatric Hematology

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).

Sponsors & Collaborators

  • Ankara City Hospital Bilkent

    lead OTHER

Principal Investigators

  • VILDAN ERGEN, MD · Ankara City Hospital Bilkent

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-05-12
Completion
2026-06-09

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07733544 on ClinicalTrials.gov