Evaluating the Feasibility and Accuracy of a Wireless Vital Sign Monitor for Observation of Adult Patients in Uganda
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Critical Illness
- Sponsor
- Neopenda, PBC
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Accuracy limits for pulse rate, oxygen saturation, respiratory rate and temperature
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
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
- Feasibility success of the wireless vital sign monitor(60 minutes)