NCT06626763

Brief Summary

The aim of this study was to determine the effect of different colored gloves on oxygen saturation in pediatric patients whose oxygen saturation was measured by pulse oximetry in pediatric emergency department. The population of the study, which is planned as a prospective cohort study, will consist of children between the ages of 3-18 years who underwent oxygen saturation measurements in the pediatric emergency clinic of İzmir Bakırçay University Cigli and Training and Research Hospital between October 2024 and October 2025.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

October 8, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2025

Completed
Last Updated

October 4, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

September 29, 2024

Last Update Submit

October 3, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Measuring the arterial blood gas SpO2 saturation

    Finger SpO2 measurements will be initiated as soon as the blood gas measurement process starts. Pulse oximetry measurements and intra-arterial blood gas measurements will be performed

    Procedure

  • without gloves measuring the SpO2 saturation

    While the patient was not wearing gloves, the pulse oximeter light source was placed on the outer surface of the finger. SpO2 was read after waiting an average of 30 seconds.

  • SpO2 saturation measurement with transparent colored glove

    While the patient was wearing a transparent glove, the pulse oximeter light source was placed on the outer surface of the finger. SpO2 was read after waiting an average of 30 seconds.

  • SpO2 saturation measurement with white colored glove

    While the patient was wearing a white glove, the pulse oximeter light source was placed on the outer surface of the finger. SpO2 was read after waiting an average of 30 seconds.

  • SpO2 saturation measurement with black colored glove

    While the patient was wearing a black glove, the pulse oximeter light source was placed on the outer surface of the finger. SpO2 was read after waiting an average of 30 seconds.

  • SpO2 saturation measurement with blue colored glove

    While the patient was wearing a blue glove, the pulse oximeter light source was placed on the outer surface of the finger. SpO2 was read after waiting an average of 30 seconds.

Study Arms (1)

Experimental

Children will be measured 5 times using a pulse oximeter. The measurements will be performed consecutively without any interval between them. The first measurement will be performed without using any gloves on the patient's finger, the second measurement will be performed using transparent gloves, the third measurement will be performed using white gloves, the fourth measurement will be performed using black gloves, and the fifth measurement will be performed using blue gloves.

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children between the ages of 3-18

You may qualify if:

  • Children between the ages of 3-18,
  • The parent/legal guardian or the child himself/herself agrees to participate in the study,
  • Arterial blood gas measurement was performed,

You may not qualify if:

  • The finger has a skin condition,
  • Having nail polish on your fingernails,
  • Having a severed finger,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İzmirKCU

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infections

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2024

First Posted

October 4, 2024

Study Start

October 8, 2024

Primary Completion

October 8, 2025

Study Completion

October 8, 2025

Last Updated

October 4, 2024

Record last verified: 2024-10

Locations