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

NCT04761432 | Completed

• 1 other identifier: MakSPH/HDREC/910
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

Critical care; Health technology; Vital sign monitoring

Outcome Measures

Primary Outcomes (1)

• Accuracy limits for pulse rate, oxygen saturation, respiratory rate and temperature

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

  30 minutes

Secondary Outcomes (1)

• Feasibility success of the wireless vital sign monitor

  60 minutes

Other Outcomes (1)

• Safety of the wireless vital sign monitor

  14 days

Study Arms (1)

Intervention arm

EXPERIMENTAL

Thirty (30) adult patients will be enrolled in this study. Each patient will be monitored simultaneously with the neoGuard device and a conventional patient monitor. Paired readings for temperature, respiratory rate, pulse rate and oxygen saturation will be captured every second for a maximum observation period of 1 hour.

Device: neoGuard

Interventions

neoGuard DEVICE

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

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Neopenda, PBC: lead
• Makerere University: collaborator

Study Sites (1)

Jinja Regional Referral Hospital

Jinja, Uganda

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Noah Kiwanuka

  Makerere University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2021
• First Posted: February 18, 2021
• Study Start: February 15, 2021
• Primary Completion: February 28, 2021
• Study Completion: May 28, 2021
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

UG (1)