Use of Integrated Pulmonary Index Monitorisation in Child... | NCT05724030

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

NCT05724030

Sponsor

Kocaeli University

Status

Completed

Last Update Posted

Oct 15, 2024Actual

Enrollment

69Actual

Phase

Not Applicable

Conditions

Cerebral Palsy
Pediatric ALL

Interventions

integrated pulmonary index
saturation

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 3, 2023Actual

Primary Completion Date

Sep 3, 2024Actual

Completion Date

Oct 11, 2024Actual

First Submitted Date

Jan 24, 2023

First Submission Date that Met QC Criteria

Feb 10, 2023

First Posted Date

Feb 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2024

Last Update Posted Date

Oct 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

69Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
integrated pulmonary index hypoxia -capnogarph	Active Comparator	integrated pulmonary index montorization apliied	Device: integrated pulmonary index Device: saturation
saturation - apnea	Experimental	saturation apllied	Device: integrated pulmonary index Device: saturation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
integrated pulmonary index	Device	integarted pumobary index monitoring	integrated pulmonary index hypoxia -capnogarph saturation - apnea

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hypoxia	desaturation spo2 below 90	20 seconds

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kocaeli University School of Medicine		Kocaeli		41900	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D000860	Hypoxia

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided