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Completed

NCT Number: NCT04761432

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jinja Regional Referral Hospital

Jinja, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

neoGuard

Device

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

Primary outcomes

  1. Accuracy limits for pulse rate, oxygen saturation, respiratory rate and temperature

    Time frame: 30 minutes

    Root Mean Square Deviation (RMSD) of measurements will be obtained.

Secondary outcomes

  1. Feasibility success of the wireless vital sign monitor

    Time frame: 60 minutes

    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.

Other outcomes

  1. Safety of the wireless vital sign monitor

    Time frame: 14 days

    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.

Sponsors and collaborators

Lead sponsor

Neopenda, PBC

Industry

Collaborators

  • Makerere University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 18, 2021
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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