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

Neopenda

Status: Completed

Conditions: Critical Illness

Treatments: Device: neoGuard

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04761432

MakSPH/HDREC/910

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18+ years (legal adult)
• Admitted for suspected or confirmed respiratory illness (excluding COVID-19)
• Stable clinical status (as determined by key physiological parameters pulse rate = 60-100 beats per minute, respiratory rate = 12-18 breaths per minute, oxygen saturation = 90 100% and temperature 36.5°C - 37.5° C)
• Willing and able to provide consent to receive vital sign monitoring

Exclusion criteria

• Aged <18 years
• Unstable clinical status as determined by physiological parameters (pulse rate <60 bpm, or >100bpm, respiratory rate <12 brpm or >18bpm, oxygen saturation <90%, temperature <36.5°C or >37.5°C)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Intervention arm

Experimental group

Description:

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.

Treatment:

Device: neoGuard