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

October 11, 2024 updated by: Zehra Ipek ARSLAN, Kocaeli University

Effect of Integrated Pulmonary Index on Hypoxia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kocaeli, Turkey, 41900
        • Kocaeli University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: integrated pulmonary index hypoxia -capnogarph
integrated pulmonary index montorization apliied
Device: integrated pulmonary index
integarted pumobary index monitoring
Device: saturation
saturation monitorization
Experimental: saturation - apnea
saturation apllied
Device: integrated pulmonary index
integarted pumobary index monitoring
Device: saturation
saturation monitorization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hypoxia
Time Frame: 20 seconds
desaturation spo2 below 90
20 seconds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
apnea - ıntegrated pulmonary index
Time Frame: 20 seconds
no respiration ıntegrated pulmonary index under 4
20 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2023

Primary Completion (Actual)

September 3, 2024

Study Completion (Actual)

October 11, 2024

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

February 10, 2023

First Posted (Actual)

February 13, 2023

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 11, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAEK/26.bl.06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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