Sedation Safety Assessment Using IPI Monitoring in Pediatric Hematologic Procedures

NCT07733544 | Completed

• 1 other identifier: TABED 1-26-2051
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation; Pediatric; BIS; Pediatric Hematology; Integrated Pulmonary Index

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Measured pre-procedure (baseline), and at 0, 1, 3, 5, 10, 15, 20, 25, and 30 minutes after initiation of the procedure.

Secondary Outcomes (5)

• 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

Study Arms (3)

Group 1 :Ages 2-5

Patients aged between 2 and 5 years undergoing hematologic procedures under sedation.

Procedure: Deep Sedation with IPI and BIS Monitoring

Group 2 : Ages 6-11

Patients aged between 6 and 11 years undergoing hematologic procedures under sedation.

Procedure: Deep Sedation with IPI and BIS Monitoring

Group 3: Ages 12-18

Patients aged between 12 and 18 years undergoing hematologic procedures under sedation.

Procedure: Deep Sedation with IPI and BIS Monitoring

Interventions

Deep Sedation with IPI and BIS Monitoring PROCEDURE

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).

Group 1 :Ages 2-5; Group 2 : Ages 6-11; Group 3: Ages 12-18

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises pediatric patients aged 2 to 18 years who are scheduled for diagnostic or therapeutic hematologic interventions (such as bone marrow aspiration or lumbar puncture) at the Pediatric Hematology and Oncology Department of Ankara City Hospital. The cohort includes patients with an ASA Physical Status of I, II, or III who require deep sedation for these procedures.

You may qualify if:

• Patients undergoing hematologic interventions (Bone Marrow ---Aspiration/Lumbar Puncture).
• ASA Physical Status I-III.
• Age 2-18 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent Şehir Hastanesi

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

Related Publications (1)

• Riphaus A, Wehrmann T, Kronshage T, Geist C, Pox CP, Heringlake S, Schmiegel W, Beitz A, Meining A, Muller M, von Delius S. Clinical value of the Integrated Pulmonary Index(R) during sedation for interventional upper GI-endoscopy: A randomized, prospective tri-center study. Dig Liver Dis. 2017 Jan;49(1):45-49. doi: 10.1016/j.dld.2016.08.124. Epub 2016 Sep 1.

  PMID: 27671621 RESULT

MeSH Terms

Interventions

Deep Sedation

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• VILDAN ERGEN, MD

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: July 29, 2026
• Study Start: April 1, 2026
• Primary Completion: May 12, 2026
• Study Completion: June 9, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)