An interventional study of Pulse oximeter sensors in Premature Birth, sponsored by Medline Industries. Completed at 2 sites in United States. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by Medline Industries · Not applicable, Interventional, and Diagnostic
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.
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.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 23 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Medline Industries is the lead sponsor of 39 studies on the registry; none are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 14 (93%) have results posted.
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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:
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.
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.
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.
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.
Device: Pulse oximeter sensors
Pulse oximeter reading will be compared to CO-oximeter reading.
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
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.
| Milestone | Pulse Oximeter Sensor Readings |
|---|---|
| Started | 23 |
| Completed | 23 |
| Not completed | 0 |
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.
| percentage of difference in mean | Sensor Massimo or Nellcor |
|---|---|
| Bias Massimo | .151 (-.361 to .662) |
| Bias Nellcor | .434 (-.149 to 1.017) |
Collected over Neonates enrolled in the study were monitored until discharge from the hospital, on average for 2 weeks.. Non-serious events are listed at a 0.0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pulse Oximeter Sensor Readings | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
23 to 29 weeks
| Age, Categorical(Participants) | Pulse Oximeter Sensor Readings |
|---|---|
| <=18 years | 23 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(Weeks) | Pulse Oximeter Sensor Readings |
|---|---|
| Mean | 23.6 ± 1.6 |
| Sex: Female, Male(Participants) | Pulse Oximeter Sensor Readings |
|---|---|
| Female | 17 |
| Male | 6 |
| Race/Ethnicity, Customized(Participants) | Pulse Oximeter Sensor Readings |
|---|---|
| Black or African American | 14 |
| White - Non Hispanic or Latino | 8 |
| Hispanic or Latino | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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