Premature Birth
Conditions
Brief summary
To validate the SpO2 accuracy, bias, and precision of Medline's reprocessed pulse oximetry sensors as compared to SaO2 in arterial blood samples as assessed by CO-oximetry in neonates.
Detailed description
Pulse oximetry helps in measuring peripheral capillary oxygen saturation (SpO2) continuously and non-invasively, and provides an indirect measurement of arterial oxygenation (SaO2) based on the red and infrared light-absorption characteristics of oxygenated and deoxygenated hemoglobin. Uses of pulse oximetry include detection of hypoxia, avoidance of hyperoxia, titration of fractional inspired oxygen, and enabling weaning from mechanical ventilation. Arterial blood gas (ABG) analysis, such as by the use of CO-oximeter, provides a direct measurement of SaO2. However, ABG analysis requires time, expense, and arterial access. Therefore, this study aims to validate the SpO2 accuracy of pulse oximetry sensors (manufactured by Nellcor and Masimo, and reprocessed by Medline Industries, LP) in neonates as compared to ABG measurements as part of their clinical standard of care (SOC), as assessed by CO-oximetry.
Interventions
DEVICEPulse oximeter sensors
Pulse oximeter reading will be compared to CO-oximeter reading.
Sponsors
Medline Industries
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No
Inclusion criteria
* Subjects who are postnatal 28 days or younger (neonates) * Subjects who are likely to receive one or more ABG measurements as part of their clinical SOC * Subjects who weigh less than 5 Kg (weight range for thesensors)
Exclusion criteria
* Subjects with current signs and symptoms of a clinically significant Patent Ductus Arteriosus (PDA) combined with a current or planned arterial line placement which will affect the validity of the co-oximetry measurement * Subjects with physical malformation of hands, fingers, feet, or toes that would limit the ability to place sensors for this study * Subjects judged by the Principal Investigator (PI) to be inappropriate for participation in this study * Subjects for whom placing a pulse oximeter will cause dermatological issues (e.g. allergic to foam rubber or adhesive tape)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bland-Altman Analysis for Nellcor Pulse Oximeter | 15 episodic minutes | BIAS Measurement and 95% confidence interval calculated using a Bland-Altman plot (mean vs. difference of SaO2 and SpO2) and an error plot (SaO2 vs. difference of SaO2 and SpO2) were generated. The B&A plot analysis is a simple way to evaluate a bias between the mean differences, and to estimate an agreement interval, within which 95% of the differences of the second method, compared to the first one, fall. Data can be analyzed both as unit differences plot and as percentage differences plot. We ran a percentage mean difference plot. |
Countries
United States
Participant flow
Recruitment details
a total of 23 neonates were recruited for the study, with 1-3 measurement pairs taken for each subject and each pulse oximetry sensor, for a total of 2, 4, or 6 measurement pairs per subject.
Participants by arm
| Arm | Count |
|---|---|
| Pulse Oximeter Sensor Readings Subjects who satisfy all of the inclusion criteria will be eligible to participate in the study, will receive intervention (the Masimo and Nellcor sensors, and their arterial blood sample will be taken in the normal course of care). This is a single arm study. Those who don't meet the inclusion/ exclusion criteria won't be eligible to participate.
Pulse oximeter sensors: Pulse oximeter reading will be compared to CO-oximeter reading. | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Pulse Oximeter Sensor Readings |
|---|---|
| Age, Categorical <=18 years | 23 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 23.6 Weeks STANDARD_DEVIATION 1.6 |
| Race/Ethnicity, Customized Black or African American | 14 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants |
| Race/Ethnicity, Customized White - Non Hispanic or Latino | 8 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Bland-Altman Analysis for Nellcor Pulse Oximeter
BIAS Measurement and 95% confidence interval calculated using a Bland-Altman plot (mean vs. difference of SaO2 and SpO2) and an error plot (SaO2 vs. difference of SaO2 and SpO2) were generated. The B&A plot analysis is a simple way to evaluate a bias between the mean differences, and to estimate an agreement interval, within which 95% of the differences of the second method, compared to the first one, fall. Data can be analyzed both as unit differences plot and as percentage differences plot. We ran a percentage mean difference plot.
Time frame: 15 episodic minutes
Population: all neonates participating in the study
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sensor Massimo or Nellcor | Bland-Altman Analysis for Nellcor Pulse Oximeter | Bias Massimo | .151 percentage of difference in mean |
| Sensor Massimo or Nellcor | Bland-Altman Analysis for Nellcor Pulse Oximeter | Bias Nellcor | .434 percentage of difference in mean |