Neonatal Respiratory DistressNOBNCT06817850
Neonatal Oximeter Bias Study
An observational study of Neonatal Respiratory Distress and Oxygenation, run by Czech Technical University in Prague at 1 site in Czechia.
Trial summary
The study aims to determine if there is a systematic difference (bias) between pulse oximeters used in control systems for automated oxygen delivery (A-FiO2) and those used in monitoring systems. When using A-FiO2 systems there are commonly two oximeter probes on the infant with two difference readouts. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neonatal Respiratory Distress, Oxygenation
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Mar 2025to 31 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All infants in the NICU monitored with two simultaneous oximeters with probes in preductal locations. The use of A-FiO2 is expected.
Who may be able to join
- Observations of any infant in the neonatal ICU with two simultaneous oximeter monitors may be included. The sites' Ethics Committee must review the protocol, approve participation and determine if Informed Consent is required. If required, it might be prospective, that is prior to collecting any data, or retrospective.
Who cannot join
- Observations are to be made at the convenience of the Investigative team. They should reflect routine situation, and not be selected to specifically capture problems. Thus, the photo should be taken immediately with both displays are on in the view, and not delayed until something interesting happens. Observations should not be made if any of the following exclusion criteria are meet. If after collection, any of these are meet, the data should not be included as an Observation on the Observation-CRF.
- One oximeter monitoring post ductal SpO2 in infant with clinically relevant shunt.
- Monitor and A-FiO2 Oximeter not reading between 70-100%
- Less than 5 minutes between repeat Observations
- No more than 5 measurements per day per subject with sensors in same position and same oximeters (i.e., every time either sensor is moved, 5 new Observations can be made that day).
- Presence of motion artifact
- Presence of sensor integrity alarms/alerts
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
Motol University Hospital, Neonatal Unit
Prague, 15500
Jana Dornakova, MD, +420607720060, Jana.Dornakova@fnmotol.cz
Jana Dornakova, MD
About this study
Official title: Evaluation of the Differences Between Simultaneous SpO2s Readings in the NICU: a Multicenter Observational Study
The study aims to determine if there is a systematic difference (bias) between pulse oximeters used in control systems for automated oxygen delivery (A-FiO2) and those used in monitoring systems.
When using A-FiO2 systems there are commonly two oximeter probes on the infant with two difference readouts. Nurses report frustration that the two readings are often markedly different. It is understandable that physiological differences between sensor sites might reflect different regional oxygen saturation levels. It is also possible that there is a relevant systematic bias between difference monitors and sensors.
Therefore, a large systematic multicenter study is needed to determine whether these frequent differences should be ignored as physiological noise or considered clinically relevant.
Read the detailed description
The accuracy of clinical pulse oximeters is specified as 3% RMS (root mean squared of the bias and variance) compared to arterial SaO2, in the range of 70-100% SpO2. This combines errors from bias and from scatter (imprecision). These validations are carried out under ideal laboratory conditions; that is, on healthy volunteers who undergo experimental desaturations, and not in the routine clinical environment. In a large multicenter clinical observation study, Ross et al in 2013 identified important related concerns. Specifically, they found that many of the clinical measurements were outside the 3% accuracy envelop. Specifically, they reported that bias varied depending on the level of saturation, the oximeter brand, sensor, race and site perfusion. Others have identified relevant differences in oximeters, oximeter sensors [Maiwald], and skin pigmentation.
Our study would be the first study in the neonatal ICU evaluating bias to consider different oximeters, sensors and sensor sites. It is highly topical in that changes in average SpO2 of 3% have been associated with excess neonatal mortality and morbidity.
This study is planned to investigate the source and magnitude of differences in SpO2 readings from oximeter sensors at different sensor sites that are routinely noticed by clinicians. While these differences are most often ignored and attributed to sensor site perfusion, if systematic they could have marked impact on mortality and morbidity.
The aim of the investigation is to provide practical guidance relating to SpO2 bias among oximeters, oximeter sensors and sensor location. While taking advantage of the clinical need for 2 oximeter sensors, the results will be applicable to all neonatal oximeter monitoring.
An observational design was selected to take place in centers using automated FiO2 control systems (A-FiO2) that routinely require the use of one sensor for control and another for monitoring. This is a refinement of the approach used in the often-cited multicenter evaluation of neonatal SpO2 exposure. Thus, without an investigational intervention the observational design is well suited to collect comparable data from multiple centers.
- Conditions
- Neonatal Respiratory Distress, Oxygenation
- Keywords
- pulse oximetry, automated FiO2 control, SpO2
- Medical subject headings
- Pulmonary Atelectasis
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 |
|---|---|---|
| Infants in the NICU with two oximeters | Infants in the NICU monitored with two oximeters with probes in preductal locations. The use of A-FiO2 is expected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bias between paired SpO2 measurements
Bias between paired SpO2 in three ranges:
- Hypoxemia (SpO2: 70 - <89.5%),
- Normoxemia (SpO2: 89.5-95.5%)
- Hyperoxemia (SpO2: >95.5-100%)
The ranges are determined as the mean of the two oximeters.
Measured: 1 month (250 observations is expected from each participating center; on average 2 patients and 5 observations per day per patient assumed)
Secondary outcomes (6)
Bias between paired SpO2 related to site
Bias between paired SpO2 (in %) in three ranges related to independent variable: site (as factor).
Measured: 1 month (250 observations is expected from each participating center; on average 2 patients and 5 observations per day per patient assumed)
Bias between paired SpO2 related to sensor location
Bias between paired SpO2 (in %) in three ranges related to independent variable: sensor location (as factor).
Measured: 1 month (250 observations is expected from each participating center; on average 2 patients and 5 observations per day per patient assumed)
Bias between paired SpO2 related to oximeter brand pairs
Bias between paired SpO2 (in %) in three ranges related to independent variable: oximeter brand pairs (as factor).
Measured: 1 month (250 observations is expected from each participating center; on average 2 patients and 5 observations per day per patient assumed)
Bias between paired SpO2 related to sensor pairs
Bias between paired SpO2 (in %) in three ranges related to independent variable: sensor pairs (as factor).
Measured: 1 month (250 observations is expected from each participating center; on average 2 patients and 5 observations per day per patient assumed)
Bias between paired SpO2 related to oximeter averaging setting
Bias between paired SpO2 (in %) in three ranges related to independent variable: oximeter averaging setting (as factor).
Measured: 1 month (250 observations is expected from each participating center; on average 2 patients and 5 observations per day per patient assumed)
Bias between paired SpO2 related to skin shade
Bias between paired SpO2 (in %) in three ranges related to independent variable: skin shade (as factor).
Measured: 1 month (250 observations is expected from each participating center; on average 2 patients and 5 observations per day per patient assumed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start15 Mar 2025 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory DistressStudies 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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Motol
- Responsible party
- Sponsor
- Investigators
- Thomas E Bachman, MSc, Principal investigator, Czech Technical University in PragueJan Janota, MD, PhD, Principal investigator, Motol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817850
- Sponsor's protocol ID
- NOB (PRICOIII)
- Acronym
- NOB
- Status last verified
- Mar 2025
- First submitted
- 21 Jan 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Differences Between Simultaneous SpO2s Readings in the NICU: a Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT06817850
- Acronym / sponsor ID
- NOB / NOB (PRICOIII)
- Conditions
- Neonatal Respiratory Distress, Oxygenation
- Keywords
- pulse oximetry, automated FiO2 control, SpO2
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Collaborators
- University Hospital, Motol
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 10 Feb 2025 (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 study aims to determine if there is a systematic difference (bias) between pulse oximeters used in control systems for automated oxygen delivery (A-FiO2) and those used in monitoring systems.
When using A-FiO2 systems there are commonly two oximeter probes on the infant with two difference readouts. Nurses report frustration that the two readings are often markedly different. It is understandable that physiological differences between sensor sites might reflect different regional oxygen saturation levels. It is also possible that there is a relevant systematic bias between difference monitors and sensors.
Therefore, a large systematic multicenter study is needed to determine whether these frequent differences should be ignored as physiological noise or considered clinically relevant.
Detailed description
The accuracy of clinical pulse oximeters is specified as 3% RMS (root mean squared of the bias and variance) compared to arterial SaO2, in the range of 70-100% SpO2. This combines errors from bias and from scatter (imprecision). These validations are carried out under ideal laboratory conditions; that is, on healthy volunteers who undergo experimental desaturations, and not in the routine clinical environment. In a large multicenter clinical observation study, Ross et al in 2013 identified important related concerns. Specifically, they found that many of the clinical measurements were outside the 3% accuracy envelop. Specifically, they reported that bias varied depending on the level of saturation, the oximeter brand, sensor, race and site perfusion. Others have identified relevant differences in oximeters, oximeter sensors [Maiwald], and skin pigmentation.
Our study would be the first study in the neonatal ICU evaluating bias to consider different oximeters, sensors and sensor sites. It is highly topical in that changes in average SpO2 of 3% have been associated with excess neonatal mortality and morbidity.
This study is planned to investigate the source and magnitude of differences in SpO2 readings from oximeter sensors at different sensor sites that are routinely noticed by clinicians. While these differences are most often ignored and attributed to sensor site perfusion, if systematic they could have marked impact on mortality and morbidity.
The aim of the investigation is to provide practical guidance relating to SpO2 bias among oximeters, oximeter sensors and sensor location. While taking advantage of the clinical need for 2 oximeter sensors, the results will be applicable to all neonatal oximeter monitoring.
An observational design was selected to take place in centers using automated FiO2 control systems (A-FiO2) that routinely require the use of one sensor for control and another for monitoring. This is a refinement of the approach used in the often-cited multicenter evaluation of neonatal SpO2 exposure. Thus, without an investigational intervention the observational design is well suited to collect comparable data from multiple centers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants in the NICU with two oximeters | – | –Infants in the NICU monitored with two oximeters with probes in preductal locations. The use of A-FiO2 is expected. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All infants in the NICU monitored with two simultaneous oximeters with probes in preductal locations. The use of A-FiO2 is expected.
Key inclusion criteria (1 listed)
- Observations of any infant in the neonatal ICU with two simultaneous oximeter monitors may be included. The sites' Ethics Committee must review the protocol, approve participation and determine if Informed Consent is required. If required, it might be prospective, that is prior to collecting any data, or retrospective.
Key exclusion criteria (7 listed)
- Observations are to be made at the convenience of the Investigative team. They should reflect routine situation, and not be selected to specifically capture problems. Thus, the photo should be taken immediately with both displays are on in the view, and not delayed until something interesting happens. Observations should not be made if any of the following exclusion criteria are meet. If after collection, any of these are meet, the data should not be included as an Observation on the Observation-CRF.
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
Bias between paired SpO2 measurements
Time frame: 1 month (250 observations is expected from each participating center; on average 2 patients and 5 observations per day per patient assumed)
Bias between paired SpO2 in three ranges: 1. Hypoxemia (SpO2: 70 - <89.5%), 2. Normoxemia (SpO2: 89.5-95.5%) 3. Hyperoxemia (SpO2: >95.5-100%) The ranges are determined as the mean of the two oximeters.
6 secondary outcomes
Bias between paired SpO2 related to site
Time frame: 1 month (250 observations is expected from each participating center; on average 2 patients and 5 observations per day per patient assumed)
Bias between paired SpO2 related to sensor location
Time frame: 1 month (250 observations is expected from each participating center; on average 2 patients and 5 observations per day per patient assumed)
Bias between paired SpO2 related to oximeter brand pairs
Time frame: 1 month (250 observations is expected from each participating center; on average 2 patients and 5 observations per day per patient assumed)
Bias between paired SpO2 related to sensor pairs
Time frame: 1 month (250 observations is expected from each participating center; on average 2 patients and 5 observations per day per patient assumed)
Bias between paired SpO2 related to oximeter averaging setting
Time frame: 1 month (250 observations is expected from each participating center; on average 2 patients and 5 observations per day per patient assumed)
Bias between paired SpO2 related to skin shade
Time frame: 1 month (250 observations is expected from each participating center; on average 2 patients and 5 observations per day per patient assumed)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Thomas E Bachman, MSc principal investigator
Czech Technical University in Prague
Jan Janota, MD, PhD principal investigator
Motol University Hospital
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 Neonatal Respiratory Distress and Oxygenation, run by Czech Technical University in Prague at 1 site in Czechia.
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 1 inclusion and 7 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: opening soon, as of the sponsor's last update on 25 Mar 2025. 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 Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jakub Rafl, PhD (+420728229991, rafl@fbmi.cvut.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bias between paired SpO2 measurements (time frame: 1 month (250 observations is expected from each participating center; on average 2 patients and 5 observations per day per patient assumed)). 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 25 Mar 2025.