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

NCT ID: NCT05724030

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-03

Study Completion Date

2024-10-11

Brief Summary

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

Detailed Description

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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.

Conditions

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Cerebral Palsy Pediatric ALL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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integrated pulmonary index hypoxia -capnogarph

integrated pulmonary index montorization apliied

Group Type ACTIVE_COMPARATOR

integrated pulmonary index

Intervention Type DEVICE

integarted pumobary index monitoring

saturation

Intervention Type DEVICE

saturation monitorization

saturation - apnea

saturation apllied

Group Type EXPERIMENTAL

integrated pulmonary index

Intervention Type DEVICE

integarted pumobary index monitoring

saturation

Intervention Type DEVICE

saturation monitorization

Interventions

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integrated pulmonary index

integarted pumobary index monitoring

Intervention Type DEVICE

saturation

saturation monitorization

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Zehra Ipek ARSLAN

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kocaeli University School of Medicine

Kocaeli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KAEK/26.bl.06

Identifier Type: -

Identifier Source: org_study_id

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