NCT05724030

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 3, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2024

Completed
Last Updated

October 15, 2024

Status Verified

December 1, 2023

Enrollment Period

1.4 years

First QC Date

January 24, 2023

Last Update Submit

October 11, 2024

Conditions

Cerebral PalsyPediatric ALL

Keywords

botilinum toxinpediatricsıntegrated pulmonary indexhypoxia

Outcome Measures

Primary Outcomes (1)

  • hypoxia

    desaturation spo2 below 90

    20 seconds

Secondary Outcomes (1)

  • apnea - ıntegrated pulmonary index

    20 seconds

Study Arms (2)

integrated pulmonary index hypoxia -capnogarph

ACTIVE COMPARATOR

integrated pulmonary index montorization apliied

Device: integrated pulmonary indexDevice: saturation

saturation - apnea

EXPERIMENTAL

saturation apllied

Device: integrated pulmonary indexDevice: saturation

Interventions

integrated pulmonary indexDEVICE

integarted pumobary index monitoring

integrated pulmonary index hypoxia -capnogarphsaturation - apnea
saturationDEVICE

saturation monitorization

integrated pulmonary index hypoxia -capnogarphsaturation - apnea

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age pediatrics
  • undergoing botilinum injection with sedation
  • asa 1-2

You may not qualify if:

  • \> 18 age
  • asa 3-4
  • patients with upper respiratory tract infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University School of Medicine

Kocaeli, 41900, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral PalsyPrecursor Cell Lymphoblastic Leukemia-LymphomaHypoxia

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 24, 2023

First Posted

February 13, 2023

Study Start

April 3, 2023

Primary Completion

September 3, 2024

Study Completion

October 11, 2024

Last Updated

October 15, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)