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

Kocaeli University

Status: Completed

Conditions: Cerebral Palsy; Pediatric ALL

Treatments: Device: integrated pulmonary index; Device: saturation

Study type: Interventional

Funder types: Other

Identifiers

NCT05724030

KAEK/26.bl.06

Details and patient eligibility

About

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

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 4 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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69 participants in 2 patient groups

integrated pulmonary index hypoxia -capnogarph

Active Comparator group

Description:

integrated pulmonary index montorization apliied

Treatment:

Device: saturation

Device: integrated pulmonary index

saturation - apnea

Experimental group

Description:

saturation apllied

Treatment:

Device: saturation

Device: integrated pulmonary index