An interventional study of neoGuard in Critical Illness, sponsored by Neopenda, PBC. Completed at 1 site in Uganda. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-22.
Sponsored by Neopenda, PBC · Not applicable, Interventional, and Other
This feasibility study will demonstrate the safety and accuracy of the Neopenda's wireless vital signs monitor, neoGuard, on 30 adult patients in a Ugandan clinical setting. The technology will be tested against a conventional patient monitor. Root mean square deviation (RMSD) and Bland-Altman plots will be used to assess concordance between paired measurements from the two equipment collected over a 1-hour period for each patient.
Continuous vital sign monitoring is a basic tenet of specialized care in the developed world that is vastly underutilized in the intensive care units of most low-and-middle income countries. Despite the positive outcomes associated with vital signs monitoring (i.e. increased survival-to-discharge, lower complication rates and shorter length of hospitalization), the prohibitive costs of conventional patient monitors and the difficulty in maintaining complex medical equipment limit its accessibility in the developing world.
This feasibility study will demonstrate the safety and accuracy of the Neopenda's wireless vital signs monitor, neoGuard, on adult patients in a Ugandan clinical setting. The technology will be tested against a conventional patient monitor. Root mean square deviation (RMSD) and Bland-Altman plots will be used to assess concordance between paired measurements from the two equipment collected over a 1-hour period for each patient.
This technology innovation has large potential to impact health outcomes in low-resource settings, as it is a portable, reusable, long-lasting, cost-efficient monitoring tool designed for settings where patient loads are high and such solutions are direly needed.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 33 is below the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Neopenda, PBC is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Thirty (30) adult patients will be enrolled in this study. Each patient will be monitored simultaneously with the neoGuard device and a conventional patient monitor. Paired readings for temperature, respiratory rate, pulse rate and oxygen saturation will be captured every second for a maximum observation period of 1 hour.
Device: neoGuard
NeoGuard is a wireless wearable vital signs monitor that continuously measures temperature, pulse rate, respiratory rate and oxygen saturation.
Accuracy limits for pulse rate, oxygen saturation, respiratory rate and temperature
Root Mean Square Deviation (RMSD) of measurements will be obtained.
Time frame: 30 minutes
Feasibility success of the wireless vital sign monitor
Likert scales will be used to rate the extent to which participants agree or disagree that the neoGuard technology is appropriate and feasible in the Ugandan clinical setting. A mean feasibility score will be calculated, with a higher value indicating greater feasibility.
Time frame: 60 minutes
Safety of the wireless vital sign monitor
The number of treatment-related adverse events (AE) and serious adverse events (SAE) will be categorized by their relationship to the treatment (i.e. "definitely related", "probably related", "possibly related", etc.) and severity (i.e. "mild", "moderate", "severe" or "life-threatening"). Researchers will report frequencies, descriptions and resolutions for each adverse event recorded.
Time frame: 14 days
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Neopenda, PBC