Critical Illness
Conditions
Keywords
Critical care, Health technology, Vital sign monitoring
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.
Interventions
DEVICEneoGuard
NeoGuard is a wireless wearable vital signs monitor that continuously measures temperature, pulse rate, respiratory rate and oxygen saturation.
Sponsors
Makerere University
Neopenda, PBC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy limits for pulse rate, oxygen saturation, respiratory rate and temperature | 30 minutes | Root Mean Square Deviation (RMSD) of measurements will be obtained. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility success of the wireless vital sign monitor | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety of the wireless vital sign monitor | 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. |
Countries
Uganda
Outcome results
None listed