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Completed

NCT Number: NCT05724030

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

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

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypoxia Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Nervous System Diseases Pathological Conditions, Signs and Symptoms Pediatric ALL Precursor Cell Lymphoblastic Leukemia-Lymphoma Signs and Symptoms Signs and Symptoms, Respiratory

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University School of Medicine

Kocaeli, 41900, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

integrated pulmonary index

Device

integarted pumobary index monitoring

saturation

Device

saturation monitorization

Primary outcomes

  1. hypoxia

    Time frame: 20 seconds

    desaturation spo2 below 90

Secondary outcomes

  1. apnea - ıntegrated pulmonary index

    Time frame: 20 seconds

    no respiration ıntegrated pulmonary index under 4

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

Effect of Integrated Pulmonary Index on Hypoxia

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2023
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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