Skip to main content
OpenTrials
Completed

NCT Number: NCT06343896

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara City Hospital, Bilkent

Ankara, Turkey (Türkiye)

About this study

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.

  • Stimulation of the patient
  • Discontinuation of the drug
  • Chin lift or chin push maneuver
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

monitorization reliability

Other

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

Primary outcomes

  1. EVALUATION OF IPI RELIABILITY IN PEDIATRIC PATIENTS

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

Secondary outcomes

  1. BİS correlation with the IPI

    Time frame: 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.

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

  2. pulse oximetry correlation with the IPI

    Time frame: 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.

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

  3. noninvasive blood pressure

    Time frame: 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.

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

  4. heart rate

    Time frame: 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.

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

  5. respiratory rate

    Time frame: 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.

    investigators will intermittently record the intraoperative patient's respiratory rate

  6. end tidal carbondioxide

    Time frame: 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.

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

  7. apnea and hypoxia conditions that develop in the patient during anesthesia

    Time frame: 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.

    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.

  8. postoperative recovery time

    Time frame: the 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

  9. intraoperative total dose of medication used

    Time frame: at the end of the operation

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

  10. postoperative nausea and vomiting

    Time frame: the 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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Acronym: IPI

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2024
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.