NCT04761432

Feasibility and Accuracy of a Wireless Vital Sign Monitor for Observation of Adult Patients in Uganda

Evaluating the Feasibility and Accuracy of a Wireless Vital Sign Monitor for Observation of Adult Patients in Uganda

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Neopenda, PBC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Critical Illness

Interventions

Type	Name	Description
DEVICE	neoGuard	NeoGuard is a wireless wearable vital signs monitor that continuously measures temperature, pulse rate, respiratory rate and oxygen saturation.

Timeline

• Start date: 2021-02-15
• Primary completion: 2021-02-28
• Completion: 2021-05-28
• First posted: 2021-02-18
• Last updated: 2023-03-22

Locations

1 site across 1 country: Uganda