Clinical trial NCT06343896: Evaluation of Sedation Depth and Reliability with Integrated Pulmonary Index (IPI) Follow-up in Pediatric Radiological Interventions
Official title: Evaluation of Sedation Depth and Reliability with Integrated Pulmonary Index (EPI) Follow-up in Pediatric Radiological Interventions with Effective Sedoanalgesia with BIS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sedation
BIS
Integrated Pulmonary Index
Keywords: Integrated Pulmonary Index
sedoanalgesia
pediatric patient
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 83
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 2-18 years of age children patients who will be treated by interventional radiology

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: EVALUATION OF IPI RELIABILITY IN PEDIATRIC PATIENTS
timeFrame: 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:
measure: BİS correlation with the IPI
timeFrame: 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.
measure: pulse oximetry correlation with the IPI
timeFrame: 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.
measure: noninvasive blood pressure
timeFrame: 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.
measure: heart rate
timeFrame: 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.
measure: respiratory rate
timeFrame: 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.
measure: end tidal carbondioxide
timeFrame: 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.
measure: apnea and hypoxia conditions that develop in the patient during anesthesia
timeFrame: 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.
measure: postoperative recovery time
timeFrame: the first 30 minutes in the postoperative recovery unit will be evaluated
measure: intraoperative total dose of medication used
timeFrame: at the end of the operation
measure: postoperative nausea and vomiting
timeFrame: the first 30 minutes in the postoperative recovery unit will be evaluated
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital, Bilkent
Study officials:
affiliation: Ankara City Hospital Bilkent
name: levent ozturk
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.