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

Effect of Integrated Pulmonary Index on Hypoxia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05724030
Enrollment
69
Registered
2023-02-13
Start date
2023-04-03
Completion date
2024-10-11
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Pediatric ALL

Keywords

botilinum toxin, pediatrics, ıntegrated pulmonary index, hypoxia

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.

Interventions

integarted pumobary index monitoring

DEVICEsaturation

saturation monitorization

Sponsors

Kocaeli University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
hypoxia20 secondsdesaturation spo2 below 90

Secondary

MeasureTime frameDescription
apnea - ıntegrated pulmonary index20 secondsno respiration ıntegrated pulmonary index under 4

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026