MedPath

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

Completed
Conditions
Sedation
Integrated Pulmonary Index
BIS
Interventions
Other: monitorization reliability
Registration Number
NCT06343896
Lead Sponsor
Ankara City Hospital Bilkent
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
83
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
PEDIATRIC PATIENTS BETWEEN 2-18 YEARS OF AGEmonitorization reliabilitymonitorization reliability evaluation of the use of the integral pulmonary index in the child patient group
Primary Outcome Measures
NameTimeMethod
EVALUATION OF IPI RELIABILITY IN PEDIATRIC PATIENTSJust 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 STATUS OF THE PATIENT WILL BE MEASURED BY IPI MONITOR DURING INTERVENTIONAL RADIOLOGICAL PROCEDURES PERFORMED IN PEDIATRIC PATIENTS UNDER SEDOANALGESIA

Secondary Outcome Measures
NameTimeMethod
BİS correlation with the IPIJust 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.

The researchers aim to show the effect of BIS value differences on IPI score.

pulse oximetry correlation with the IPIJust 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.

The researchers aim to show the effect of pulse oximetry value differences on IPI score.

noninvasive blood pressureJust 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.

investigators will intermittently record the intraoperative patient's noninvasive blood pressure

heart rateJust 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.

investigators will intermittently record the intraoperative patient's heart rate with ECG monitoring

respiratory rateJust 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.

investigators will intermittently record the intraoperative patient's respiratory rate

end tidal carbondioxideJust 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.

investigators will intermittently record the intraoperative patient's end tidal carbon dioxide value

apnea and hypoxia conditions that develop in the patient during anesthesiaJust 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.

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.

postoperative recovery timethe first 30 minutes in the postoperative recovery unit will be evaluated

From the end of the operation until the patient is recovered, the patient will be followed up in the recovery unit

intraoperative total dose of medication usedat the end of the operation

The investigators will record the total intraoperative drug dose at the end of the operation.

postoperative nausea and vomitingthe first 30 minutes in the postoperative recovery unit will be evaluated

will be evaluated in the recovery unit within the first 30 minutes in the perioperative period.

Trial Locations

Locations (1)

Ankara City Hospital, Bilkent

🇹🇷

Ankara, Turkey

© Copyright 2025. All Rights Reserved by MedPath