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

NCT06343896 | Completed

• 1 other identifier: AnkaraCHBilkent-tntaygurt
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sedation; BIS; Integrated Pulmonary Index

Keywords

Integrated Pulmonary Index; sedoanalgesia; pediatric patient

Outcome Measures

Primary Outcomes (1)

• EVALUATION OF IPI RELIABILITY IN PEDIATRIC PATIENTS

  RESPIRATORY STATUS OF THE PATIENT WILL BE MEASURED BY IPI MONITOR DURING INTERVENTIONAL RADIOLOGICAL PROCEDURES PERFORMED IN PEDIATRIC PATIENTS UNDER SEDOANALGESIA

  Just before induction, 1.-2.-4.- 6.- 8-10.-15.-20.-25.-30. minutes and then every 5 minutes until the patient comes out of anesthesia. maximum duration of anesthesia was determined as 60 minutes.

Secondary Outcomes (10)

• BİS correlation with the IPI

  Just before induction, 1.-2.-4.- 6.- 8-10.-15.-20.-25.-30. minutes and then every 5 minutes until the patient comes out of anesthesia. maximum duration of anesthesia was determined as 60 minutes.

• pulse oximetry correlation with the IPI

  Just before induction, 1.-2.-4.- 6.- 8-10.-15.-20.-25.-30. minutes and then every 5 minutes until the patient comes out of anesthesia. maximum duration of anesthesia was determined as 60 minutes.

• noninvasive blood pressure

  Just before induction, 1.-2.-4.- 6.- 8-10.-15.-20.-25.-30. minutes and then every 5 minutes until the patient comes out of anesthesia. maximum duration of anesthesia was determined as 60 minutes.

• heart rate

  Just before induction, 1.-2.-4.- 6.- 8-10.-15.-20.-25.-30. minutes and then every 5 minutes until the patient comes out of anesthesia. maximum duration of anesthesia was determined as 60 minutes.

• respiratory rate

  Just before induction, 1.-2.-4.- 6.- 8-10.-15.-20.-25.-30. minutes and then every 5 minutes until the patient comes out of anesthesia. maximum duration of anesthesia was determined as 60 minutes.

Study Arms (1)

PEDIATRIC PATIENTS BETWEEN 2-18 YEARS OF AGE

monitorization reliability evaluation of the use of the integral pulmonary index in the child patient group

Other: monitorization reliability

Interventions

monitorization reliability OTHER

evaluation of the use of the integral pulmonary index in the child patient group

PEDIATRIC PATIENTS BETWEEN 2-18 YEARS OF AGE

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

2-18 years of age children patients who will be treated by interventional radiology

You may qualify if:

• ASA(American Society of Anesthesiologists classification) 1-2-3 ,2-18 years of age children patients who will be treated by interventional radiology

You may not qualify if:

• patients whose parents do not wish to participate in the research
• patients with ASA scoring greater than 4 and 4'
• Patients who are allergic to any of the drugs used or who have any contraindications for the use of the drug
• Patients with advanced organ failure (heart, kidney, liver, lung)
• Patients with intracranial mass (CIBAS), epilepsy or neuromuscular disease

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital, Bilkent

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

• Nelson O, Bailey PD Jr. Pediatric Anesthesia Considerations for Interventional Radiology. Anesthesiol Clin. 2017 Dec;35(4):701-714. doi: 10.1016/j.anclin.2017.08.003.

  PMID: 29101959 BACKGROUND

• 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 BACKGROUND

Study Officials

• levent ozturk

  Ankara City Hospital Bilkent

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 3, 2024
• Study Start: April 1, 2024
• Primary Completion: June 15, 2024
• Study Completion: September 1, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)