Pulse OximetryNCT03843489
SpO2 Accuracy In Vivo Testing for Neonates & Infants
A study testing MEDLINE RENEWAL PULSE OXIMETRY SENSORS and Reference CO-oximetry sensor in people with Pulse Oximetry, run by Medline Industries at 1 site in United States.
Trial summary
The purpose of this clinical study is to validate the oxygen saturation (SpO2) accuracy of various pulse oximetry systems and sensors (new designs and/or reprocessed) during non-motion conditions as compared to arterial blood samples, drawn in the normal course of patient care, assessed by CO-Oximetry in neonates and… Read more about this study
- Who is it for?
- Ages Up to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Pulse Oximetry
- What is being tested?
- MEDLINE RENEWAL PULSE OXIMETRY SENSORS and Reference CO-oximetry sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2019to 20 Sep 2021
- Phase
- Interventional
- 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 Up to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Neonates/Infants up to 28 days old
- Neonates/Infants less than 5kg.
- And one of the following:
- Without PDA With a PDA with R-L shunting that will be repaired before arterial samples are taken
Who cannot join
- Physical malformation of feet or toes or other sensor sites which would limit the ability to place the sensors for the study.
- Neonates/Infants older than 28 days old.
- Neonates/Infants outside the weight range for the sensor (Greater than 5kg.)
- Neonates/Infants with unrepaired PDA. with PDA with R-L shunting
- Subjects who are undergoing bilirubin light therapy while samples are being obtained.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: SpO2 Accuracy In Vivo Testing for Neonates & Infants - Convenience Arterial Samples Compared to CO-Oximetry
The purpose of this clinical study is to validate the oxygen saturation (SpO2) accuracy of various pulse oximetry systems and sensors (new designs and/or reprocessed) during non-motion conditions as compared to arterial blood samples, drawn in the normal course of patient care, assessed by CO-Oximetry in neonates and infants. The primary end goal is to provide supporting documentation for the SpO2 accuracy of these pulse oximetry systems. The secondary end goal is to provide data for evaluation of clinical impact of measured to calculated SaO2 and related issues.
Read the detailed description
FDA Guidance for pulse oximeters (March 4, 2013), section 4.1.2, In vivo testing for SpO2 accuracy for neonates, calls for the devices to be first tested in adults during hypoxia tests with arterial samples compared to measured oxygen saturation. This has been previously completed on the devices that will be tested in this protocol. In order to verify safe clinical performance in the neonate, the FDA then requires testing using neonatal arterial samples that are collected in the normal course of care; which is the primary purpose of this protocol. As a secondary purpose the data will be utilized to evaluate the impact of calculated oxygen saturation versus measured oxygen saturation and related issues.
Neonates/infants who will have an arterial line or sheath placed in the normal course of care will be included in this study. The pulse oximeter sensor must be placed on the Neonates/infant's foot or hand. Neonates who either have repaired PDA but are having the placement of the sensor on the foot (which will be arterial blood only) will be allowed as long as other inclusion/exclusion criteria are met.
- Conditions
- Pulse Oximetry
- Being tested
- MEDLINE RENEWAL PULSE OXIMETRY SENSORS, Reference CO-oximetry sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDLINE RENEWAL PULSE OXIMETRY SENSORSDevice
An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. Because an arterial sample of blood is not required to make the measurement, the pulse oximeter can provide non-invasive real time information.
Reference CO-oximetry sensorDevice
A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study.
| Study group | Role | What they receive |
|---|---|---|
| MEDLINE RENEWAL PULSE OXIMETRY SENSORS | Experimental | Reference sensors from the reprocessed oximeter device will be placed on each subject to evaluate the SpO2 accuracy and performance. Receives: Device: MEDLINE RENEWAL PULSE OXIMETRY SENSORS |
| Reference CO-oximetry sensor | Sham comparator | A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study. Receives: Device: Reference CO-oximetry sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of SpO2 accuracy of pulse oximetry sensors
To validate SpO2 accuracy performance of Sponsor sensors by an Accuracy Root Mean Square (Arms) value. Reference CO-Oximetry will be used as the basis for comparison for the investigational device SpO2 readings.
Measured: 4 hours
Secondary outcomes (1)
Calculated oxygen saturation versus measured oxygen saturation
The arterial sample will always be measured in the reference co-oximeter. The sample may also be measured in the currently used AVOX 1000E.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start19 Mar 2019 (estimated)
- Primary completion20 Sep 2021 (estimated)
- Study completion20 Sep 2021 (estimated)
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulse OximetryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Hospital staff will place the pulse oximeter sensor(s) on one or both hand or feet of the neonate/infant and start the pulse oximeter data collection computer to record continuously. Each time an arterial CO-Oximeter sample is collected the data collection file will be marked by pressing the file marker key on the data collection computer. Information from each arterial CO-Oximeter sample will be written on the CRF. The arterial sample will always be measured in the reference co-oximeter. The sample may also be measured in the currently used AVOX 1000E. This study will only use arterial blood samples that are taken in the normal course of care; the sample size of the blood draw will not be altered for this study (sample size will not be increased from the normal course of care for any portion of this study).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medline Industries
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinimark, LLC
- Responsible party
- Sponsor
- Investigators
- Robin Deterding, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843489
- Sponsor's protocol ID
- PR2018-296
- Status last verified
- Aug 2024
- First submitted
- 12 Feb 2019
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpO2 Accuracy In Vivo Testing for Neonates & Infants - Convenience Arterial Samples Compared to CO-Oximetry
- ClinicalTrials.gov ID
- NCT03843489
- Acronym / sponsor ID
- PR2018-296
- Conditions
- Pulse Oximetry
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medline IndustriesIndustry (pharma, biotech, devices)
- Collaborators
- Clinimark, LLC
- Study start
- 19 Mar 2019 (estimated)
- Primary completion
- 20 Sep 2021 (estimated)
- Study completion
- 20 Sep 2021 (estimated)
- First posted
- 18 Feb 2019 (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 purpose of this clinical study is to validate the oxygen saturation (SpO2) accuracy of various pulse oximetry systems and sensors (new designs and/or reprocessed) during non-motion conditions as compared to arterial blood samples, drawn in the normal course of patient care, assessed by CO-Oximetry in neonates and infants. The primary end goal is to provide supporting documentation for the SpO2 accuracy of these pulse oximetry systems. The secondary end goal is to provide data for evaluation of clinical impact of measured to calculated SaO2 and related issues.
Detailed description
FDA Guidance for pulse oximeters (March 4, 2013), section 4.1.2, In vivo testing for SpO2 accuracy for neonates, calls for the devices to be first tested in adults during hypoxia tests with arterial samples compared to measured oxygen saturation. This has been previously completed on the devices that will be tested in this protocol. In order to verify safe clinical performance in the neonate, the FDA then requires testing using neonatal arterial samples that are collected in the normal course of care; which is the primary purpose of this protocol. As a secondary purpose the data will be utilized to evaluate the impact of calculated oxygen saturation versus measured oxygen saturation and related issues.
Neonates/infants who will have an arterial line or sheath placed in the normal course of care will be included in this study. The pulse oximeter sensor must be placed on the Neonates/infant's foot or hand. Neonates who either have repaired PDA but are having the placement of the sensor on the foot (which will be arterial blood only) will be allowed as long as other inclusion/exclusion criteria are met.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hospital staff will place the pulse oximeter sensor(s) on one or both hand or feet of the neonate/infant and start the pulse oximeter data collection computer to record continuously. Each time an arterial CO-Oximeter sample is collected the data collection file will be marked by pressing the file marker key on the data collection computer. Information from each arterial CO-Oximeter sample will be written on the CRF. The arterial sample will always be measured in the reference co-oximeter. The sample may also be measured in the currently used AVOX 1000E. This study will only use arterial blood samples that are taken in the normal course of care; the sample size of the blood draw will not be altered for this study (sample size will not be increased from the normal course of care for any portion of this study).
| Arm | Type | Receives |
|---|---|---|
| MEDLINE RENEWAL PULSE OXIMETRY SENSORS | Experimental | Device: MEDLINE RENEWAL PULSE OXIMETRY SENSORSReference sensors from the reprocessed oximeter device will be placed on each subject to evaluate the SpO2 accuracy and performance. |
| Reference CO-oximetry sensor | Sham comparator | Device: Reference CO-oximetry sensorA whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Neonates/Infants up to 28 days old
- Neonates/Infants less than 5kg.
- Without PDA With a PDA with R-L shunting that will be repaired before arterial samples are taken
Key exclusion criteria (5 listed)
- Physical malformation of feet or toes or other sensor sites which would limit the ability to place the sensors for the study.
- Neonates/Infants older than 28 days old.
- Neonates/Infants outside the weight range for the sensor (Greater than 5kg.)
- Neonates/Infants with unrepaired PDA. with PDA with R-L shunting
- Subjects who are undergoing bilirubin light therapy while samples are being obtained.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDLINE RENEWAL PULSE OXIMETRY SENSORSAn oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. Because an arterial sample of blood is not required to make the measurement, the pulse oximeter can provide non-invasive real time information. | Device | MEDLINE RENEWAL PULSE OXIMETRY SENSORS |
| Reference CO-oximetry sensorA whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study. | Device | Reference CO-oximetry sensor |
Primary outcome
Validation of SpO2 accuracy of pulse oximetry sensors
Time frame: 4 hours
To validate SpO2 accuracy performance of Sponsor sensors by an Accuracy Root Mean Square (Arms) value. Reference CO-Oximetry will be used as the basis for comparison for the investigational device SpO2 readings.
1 secondary outcome
Calculated oxygen saturation versus measured oxygen saturation
Time frame: 4 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
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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.
Robin Deterding, MD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEDLINE RENEWAL PULSE OXIMETRY SENSORS and Reference CO-oximetry sensor in people with Pulse Oximetry, run by Medline Industries at 1 site in United States.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 28 Aug 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of SpO2 accuracy of pulse oximetry sensors (time frame: 4 hours). 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 28 Aug 2024.