NCT06343896

Evaluation of Sedation Depth and Reliability With Integrated Pulmonary Index (IPI) Follow-up in Pediatric Radiological Interventions

Evaluation of Sedation Depth and Reliability With Integrated Pulmonary Index (EPI) Follow-up in Pediatric Radiological Interventions With Effective Sedoanalgesia With BIS

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 83 (actual)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Accepted

Summary

In this study, we aimed to investigate the predictability of possible respiratory complications and the effect of the addition of the integrated pulmonary (EPI) score to the evaluation of the patient's respiratory index status in addition to the SPO2 measurement available in standard ASA monitoring in pediatric patients undergoing interventional radiological procedures under sedoanesthesia.

Detailed description

This study is a single-center observational study. Patients who will undergo interventional radiologic procedures under sedoanalgesia by the radiology clinic in the pediatric operating room of the hospital will be included in the study. This study is planned to include ASA 1-3 83 children aged 2-18 years. After obtaining the voluntary consent of the patients, anesthesia methods routinely applied in the hospital pediatric operating room will be applied. Noninvasive blood pressure, pulse oximetry, ECG, EPI and BS monitoring will be performed. Then 4 lt/min oxygen will be started with nasal EPI cannula. Pre-processing, 0.min, 1.min, 2.min, 4.min, 6.min, 8.min,10.dk and later systolic-diastolic and average arterial blood pressure, pulse, SPO2, BIS value, EPI value, number of breaths, ETCO2 will be recorded every 5 minutes. Apnea attacks will be recorded with ETCO2 tracking during the procedure. The capnographic criterion for an apnea episode is the inability to measure ETCO2 over a period of 15 seconds. Any apnea episode detected by clinical observation or any decrease of IPI ≤ 6 points, as well as a decrease of peripheral oxygen saturation to 92% and below, will be evaluated as hypoxia and result in an intervention including. 1. Stimulation of the patient 2. Discontinuation of the drug 3. Chin lift or chin push maneuver 4. Enhancing oxygen supplementation The necessary interventions will be performed in apnea and hypoxia states and the interventions applied when the hemodynamics of the patient is stable will be recorded The compilation time will be recorded by checking the eye opening, oral response and orientation improvement as cognitive parameters.

Conditions

• Sedation
• BIS
• Integrated Pulmonary Index

Interventions

Type	Name	Description
OTHER	monitorization reliability	evaluation of the use of the integral pulmonary index in the child patient group

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-06-15
• Completion: 2024-09-01
• First posted: 2024-04-03
• Last updated: 2025-01-31

Locations

1 site across 1 country: Turkey (Türkiye)