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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04761432
• Other study ID #: MakSPH/HDREC/910
• Status: Completed
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: May 28, 2021

Study information

• Verified date: March 2023
• Source: Neopenda, PBC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness

Intervention

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

Locations

Country	Name	City	State
Uganda	Jinja Regional Referral Hospital	Jinja

Sponsors (2)

Lead Sponsor	Collaborator
Neopenda, PBC	Makerere University

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety of the wireless vital sign monitor	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.	14 days
Primary	Accuracy limits for pulse rate, oxygen saturation, respiratory rate and temperature	Root Mean Square Deviation (RMSD) of measurements will be obtained.	30 minutes
Secondary	Feasibility success of the wireless vital sign monitor	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.	60 minutes