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NCT05724030 Clinical Trial

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

Cerebral Palsy Clinical Trial

Official title:
Effect of ıntegrated Pulmonary Index on Hypoxia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05724030
Other study ID # KAEK/26.bl.06
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 3, 2023
Est. completion date December 1, 2024

Study information
Verified date December 2023
Source Kocaeli University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 75
Est. completion date December 1, 2024
Est. primary completion date April 3, 2023
Accepts healthy volunteers No
Gender All
Age group 4 Years to 16 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• integrated pulmonary index
integarted pumobary index monitoring
• saturation
saturation monitorization

Locations
Country Name City State
Turkey Kocaeli University School of Medicine Kocaeli

Sponsors (1)
Lead Sponsor Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary hypoxia desaturation spo2 below 90 20 seconds
Secondary apnea - integrated pulmonary index no respiration integrated pulmonary index under 4 20 seconds
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