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

A

Ankara City Hospital

Status

Completed

Conditions

Integrated Pulmonary Index
Sedation
BIS

Treatments

Other: monitorization reliability

Study type

Observational

Funder types

Other

Identifiers

NCT06343896
AnkaraCHBilkent-tntaygurt

Details and patient eligibility

About

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.

Full 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.

Enrollment

83 patients

Sex

All

Ages

2 to 18 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

83 participants in 1 patient group

PEDIATRIC PATIENTS BETWEEN 2-18 YEARS OF AGE
Description:
monitorization reliability evaluation of the use of the integral pulmonary index in the child patient group
Treatment:
Other: monitorization reliability

Trial contacts and locations

1

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Central trial contact

VİLDAN ERGEN, MD; TUGBA NUR TAYGURT, MD

Data sourced from clinicaltrials.gov

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