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

Primary Purpose

Cerebral Palsy, Pediatric ALL

Status

Not yet recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

integrated pulmonary index

saturation

About this trial

This is an interventional diagnostic trial for Cerebral Palsy focused on measuring botilinum toxin, pediatrics, ıntegrated pulmonary index, hypoxia

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kocaeli University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

integrated pulmonary index hypoxia -capnogarph

saturation - apnea

Arm Description

integrated pulmonary index montorization apliied

saturation apllied

Outcomes

Primary Outcome Measures

hypoxia

desaturation spo2 below 90

Secondary Outcome Measures

apnea - ıntegrated pulmonary index

no respiration ıntegrated pulmonary index under 4

Full Information

NCT ID

NCT05724030

First Posted

January 24, 2023

Last Updated

March 31, 2023

Sponsor

Kirsehir Ahi Evran University

1. Study Identification

Unique Protocol Identification Number

NCT05724030

Brief Title

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

Official Title

Effect of ıntegrated Pulmonary Index on Hypoxia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 3, 2023 (Anticipated)

Primary Completion Date

April 3, 2023 (Anticipated)

Study Completion Date

April 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kirsehir Ahi Evran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy, Pediatric ALL

Keywords

botilinum toxin, pediatrics, ıntegrated pulmonary index, hypoxia

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

integrated pulmonary index hypoxia -capnogarph

Arm Type

Active Comparator

Arm Description

integrated pulmonary index montorization apliied

Arm Title

saturation - apnea

Arm Type

Experimental

Arm Description

saturation apllied

Intervention Type

Device

Intervention Name(s)

integrated pulmonary index

Intervention Description

integarted pumobary index monitoring

Intervention Type

Device

Intervention Name(s)

saturation

Intervention Description

saturation monitorization

Primary Outcome Measure Information:

Title

hypoxia

Description

desaturation spo2 below 90

Time Frame

20 seconds

Secondary Outcome Measure Information:

Title

apnea - ıntegrated pulmonary index

Description

no respiration ıntegrated pulmonary index under 4

Time Frame

20 seconds

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Kocaeli University School of Medicine

City

Kocaeli

ZIP/Postal Code

41900

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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