Clinical trial NCT04761432: Feasibility and Accuracy of a Wireless Vital Sign Monitor for Observation of Adult Patients in Uganda
Official title: Evaluating the Feasibility and Accuracy of a Wireless Vital Sign Monitor for Observation of Adult Patients in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: Critical care
Health technology
Vital sign monitoring
Lead sponsor: Neopenda, PBC
Sponsor class: INDUSTRY
Collaborators: name: Makerere University
First posted: 2021-02-18
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Accuracy limits for pulse rate, oxygen saturation, respiratory rate and temperature
timeFrame: 30 minutes
Secondary outcomes:
measure: Feasibility success of the wireless vital sign monitor
timeFrame: 60 minutes
Other outcomes:
measure: Safety of the wireless vital sign monitor
timeFrame: 14 days
Locations:
city: Jinja
country: Uganda
facility: Jinja Regional Referral Hospital
Study officials:
affiliation: Makerere University
name: Noah Kiwanuka
role: PRINCIPAL_INVESTIGATOR
References: