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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sedation; BIS; Integrated Pulmonary Index
• Intervention / Treatment: Other: monitorization reliability

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 68 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.

• Study Type: Observational
• Enrollment (Estimated): 68

Contacts and Locations

• Study Contact: Name: TUGBA NUR TAYGURT, MD; Phone Number: 05322005632; Email: tugbanurtaygurt@gmail.com
• Study Contact Backup: Name: VİLDAN ERGEN, MD; Phone Number: 05321511040; Email: vildanergen06@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • Ankara City Hospital, Bilkent
    • Contact: tugbanur taygurt; Phone Number: +905322005632; Email: tugbanurtaygurt@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; evaluation of the use of the integral pulmonary index in the child patient group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 min, 2 min, 4 min, 6 min, 8 min, 10 min, 15 min, 20 min, 25 min, 30 min and then every 5 min until the patient comes out of anesthesia. maximum duration of anesthesia was determined as 60 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BİS correlation with the IPI	The researchers aim to show the effect of BIS value differences on IPI score.	Just before induction, 1 min, 2 min, 4 min, 6 min, 8 min, 10 min, 15 min, 20 min, 25 min, 30 min and then every 5 min until the patient comes out of anesthesia. maximum duration of anesthesia was determined as 60 minutes.
pulse oximetry correlation with the IPI	The researchers aim to show the effect of pulse oximetry value differences on IPI score.	Just before induction, 1 min, 2 min, 4 min, 6 min, 8 min, 10 min, 15 min, 20 min, 25 min, 30 min and then every 5 min until the patient comes out of anesthesia. maximum duration of anesthesia was determined as 60 minutes.
noninvasive blood pressure	investigators will intermittently record the intraoperative patient's noninvasive blood pressure	Just before induction, 1 min, 2 min, 4 min, 6 min, 8 min, 10 min, 15 min, 20 min, 25 min, 30 min and then every 5 min until the patient comes out of anesthesia. maximum duration of anesthesia was determined as 60 minutes.
heart rate	investigators will intermittently record the intraoperative patient's heart rate with ECG monitoring	Just before induction, 1 min, 2 min, 4 min, 6 min, 8 min, 10 min, 15 min, 20 min, 25 min, 30 min and then every 5 min until the patient comes out of anesthesia. maximum duration of anesthesia was determined as 60 minutes.
respiratory rate	investigators will intermittently record the intraoperative patient's respiratory rate	Just before induction, 1 min, 2 min, 4 min, 6 min, 8 min, 10 min, 15 min, 20 min, 25 min, 30 min and then every 5 min until the patient comes out of anesthesia. maximum duration of anesthesia was determined as 60 minutes.
end tidal carbondioxide	investigators will intermittently record the intraoperative patient's end tidal carbon dioxide value	Just before induction, 1 min, 2 min, 4 min, 6 min, 8 min, 10 min, 15 min, 20 min, 25 min, 30 min and then every 5 min until the patient comes out of anesthesia. maximum duration of anesthesia was determined as 60 minutes.
apnea and hypoxia conditions that develop in the patient during anesthesia	The investigators will record the apnea and hypoxia that develop in the patient during anesthesia and whether they are intervened or not. hypoxia will be defined as a spo2 value of 92 and below.	Just before induction, 1 min, 2 min, 4 min, 6 min, 8 min, 10 min, 15 min, 20 min, 25 min, 30 min and then every 5 min until the patient comes out of anesthesia. maximum duration of anesthesia was determined as 60 minutes.
postoperative recovery time	From the end of the operation until the patient is recovered, the patient will be followed up in the recovery unit	the first 30 minutes in the postoperative recovery unit will be evaluated
intraoperative total dose of medication used	The investigators will record the total intraoperative drug dose at the end of the operation.	at the end of the operation
postoperative nausea and vomiting	will be evaluated in the recovery unit within the first 30 minutes in the perioperative period.	the first 30 minutes in the postoperative recovery unit will be evaluated

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Study Chair: levent ozturk, Ankara City Hospital Bilkent

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): October 15, 2024

Study Registration Dates

• First Submitted: March 27, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: pediatric patient; Integrated Pulmonary Index; sedoanalgesia
• Other Study ID Numbers: AnkaraCHBilkent-tntaygurt

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No