Neonatal Oximeter Bias Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCzech Technical University in Prague
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
All infants in the NICU monitored with two simultaneous oximeters with probes in preductal locations. The use of A-FiO2 is expected.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 1 trial groupGroup A: Infants in the NICU with two oximeters
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Czech Technical University in Prague
Lead sponsor
University Hospital, Motol
Collaborator
Source ClinicalTrials.gov
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