InfectionNCT06626763
Comparison of Oxygen Saturation Measurements Using Different Glove Colors in Children
An observational study of Infection and Oxygen Saturation, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection, Oxygen Saturation, Children
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Oct 2024to 8 Oct 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children between the ages of 3-18
Who may be able to join
- 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,
Who cannot join
- The finger has a skin condition,
- Having nail polish on your fingernails,
- Having a severed finger,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Infection, Oxygen Saturation, Children
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Procedure
without gloves measuring the SpO2 saturation
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start8 Oct 2024 (estimated)
- Primary completion8 Oct 2025 (estimated)
- Study completion8 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 68 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ELİZ GECTAN, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626763
- Sponsor's protocol ID
- 1753
- Status last verified
- Oct 2024
- First submitted
- 29 Sep 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oxygen Saturation Measurements Using Different Glove Colors in Children: A Preventive Method for Infection?
- ClinicalTrials.gov ID
- NCT06626763
- Acronym / sponsor ID
- 1753
- Conditions
- Infection, Oxygen Saturation, Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 8 Oct 2024 (estimated)
- Primary completion
- 8 Oct 2025 (estimated)
- Study completion
- 8 Oct 2025 (estimated)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children between the ages of 3-18
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (3 listed)
- The finger has a skin condition,
- Having nail polish on your fingernails,
- Having a severed finger,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection and Oxygen Saturation, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eliz Geçtan (05451342435, elizgectan09@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the arterial blood gas SpO2 saturation (time frame: Procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.