Use of Integrated Pulmonary Index Monitorisation in Children Undergoing Botulinum Toxin Injection

Not Applicable

Completed

• Conditions: Cerebral Palsy; Pediatric ALL
• Interventions: Device: saturation; Device: integrated pulmonary index

• Registration Number: NCT05724030
• Lead Sponsor: Kocaeli University

Brief Summary

This study aimed to detect hypoxia early with ıntegrated pulmonary index monitoring compared to saturation.

Detailed Description

This trial will be held at the kocaeli Universty Hospital. 75 children 4-17 years of age undergoing botulinum toxin injection with sedation will be enrolled in this prospective study. Patients premedicated with midasolam iv 0.5 mg bolus and then sedated with propofol 1 mg/kg and fentanyl 0.5 mg/kg . Integrated pulmonary monitoring and noninvasive capnograhy will be used. Bis monitoring and spo2 monitoring will be applied. standard anesthesia monitoring including noninvasive blood pressure, spo2 , ekg and heart rate will be monitored. This trial aimed to detect hypoxia and apnea earlier than pulse oximetry.

Study Timeline

• Study First Submitted: 2023-01-24
• Study First Submitted QC: 2023-02-10
• Study First Posted: 2023-02-13
• Study Start: 2023-04-03
• Status Verified: 2023-12
• Primary Completion: 2024-09-03
• Study Completion: 2024-10-11
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• 4-16 age pediatrics
• undergoing botilinum injection with sedation
• asa 1-2

Exclusion Criteria

• > 18 age
• asa 3-4
• patients with upper respiratory tract infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
saturation - apnea	saturation	saturation apllied
integrated pulmonary index hypoxia -capnogarph	integrated pulmonary index	integrated pulmonary index montorization apliied

Primary Outcome Measures

Name	Time	Method
hypoxia	20 seconds	desaturation spo2 below 90

Secondary Outcome Measures

Name	Time	Method
apnea - ıntegrated pulmonary index	20 seconds	no respiration ıntegrated pulmonary index under 4

Trial Locations

Locations (1)

Kocaeli University School of Medicine; 🇹🇷 Kocaeli, Turkey