An observational study in Neonatal Respiratory Distress and Oxygenation, sponsored by Czech Technical University in Prague. Not yet recruiting at 1 site in Czechia. Per ClinicalTrials.gov, last updated 2025-03-25.
Sponsored by Czech Technical University in Prague · Observational
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.
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.
377 studies on the registry are indexed under Pulmonary Atelectasis; 93 are open to participants now.
This study's planned enrollment of 40 is below the median of 76 across 100 observational studies indexed under Pulmonary Atelectasis.
Browse Pulmonary Atelectasis studies →Czech Technical University in Prague is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All infants in the NICU monitored with two simultaneous oximeters with probes in preductal locations. The use of A-FiO2 is expected.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Infants in the NICU monitored with two oximeters with probes in preductal locations. The use of A-FiO2 is expected.
Bias between paired SpO2 measurements
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.
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 site
Bias between paired SpO2 (in %) in three ranges related to independent variable: site (as factor).
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
Bias between paired SpO2 (in %) in three ranges related to independent variable: sensor location (as factor).
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
Bias between paired SpO2 (in %) in three ranges related to independent variable: oximeter brand pairs (as factor).
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
Bias between paired SpO2 (in %) in three ranges related to independent variable: sensor pairs (as factor).
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
Bias between paired SpO2 (in %) in three ranges related to independent variable: oximeter averaging setting (as factor).
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
Bias between paired SpO2 (in %) in three ranges related to independent variable: skin shade (as factor).
Time frame: 1 month (250 observations is expected from each participating center; on average 2 patients and 5 observations per day per patient assumed)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Czech Technical University in Prague