Comparison of Oxygen Saturation Measurements Using Different Glove Colors in Children

October 3, 2024 updated by: ELİZ GECTAN, Izmir Katip Celebi University

Comparison of Oxygen Saturation Measurements Using Different Glove Colors in Children: A Preventive Method for Infection?

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The aim of this study was to determine the effect of different colored gloves on oxygen saturation in pediatric patients who underwent oxygen saturation measurement by pulse oximetry in pediatric emergency department. The population of the study, which is planned as a prospective cohort study, will consist of children aged 3-18 years who underwent oxygen saturation measurements in the pediatric emergency clinic of İzmir Bakırçay University Çiğli and Training and Research Hospital between October 2024 and October 2025. The sample of the study will consist of children who meet the inclusion criteria on the specified dates and whose parents/legal guardians agree to participate in the study. Descriptive Characteristics Form and Oxygen Saturation Measurement Value Record Form will be used for data collection.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Izmir, Turkey
        • İzmirKCU

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Children between the ages of 3-18

Description

Inclusion Criteria:

  • 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,

Exclusion Criteria:

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

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measuring the arterial blood gas SpO2 saturation
Time Frame: Procedure
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Izmir Katip Celebi 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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 8, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 8, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 8, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1753

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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