Critical IllnessNCT04761432
Feasibility and Accuracy of a Wireless Vital Sign Monitor for Observation of Adult Patients in Uganda
A study testing neoGuard in people with Critical Illness, run by Neopenda, PBC at 1 site in Uganda.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- neoGuard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUganda
- Study dates
- 15 Feb 2021to 28 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Feasibility and Accuracy of a Wireless Vital Sign Monitor for Observation of Adult Patients in Uganda
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.
Read the 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.
- Conditions
- Critical Illness
- Being tested
- neoGuard
- Keywords
- Critical care, Health technology, Vital sign monitoring
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoGuardDevice
NeoGuard is a wireless wearable vital signs monitor that continuously measures temperature, pulse rate, respiratory rate and oxygen saturation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: neoGuard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy limits for pulse rate, oxygen saturation, respiratory rate and temperature
Root Mean Square Deviation (RMSD) of measurements will be obtained.
Measured: 30 minutes
Secondary outcomes (1)
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.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start15 Feb 2021
- Primary completion28 Feb 2021
- Study completion28 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neopenda, PBC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Makerere University
- Responsible party
- Sponsor
- Investigators
- Noah Kiwanuka, Principal investigator, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761432
- Sponsor's protocol ID
- MakSPH/HDREC/910
- Status last verified
- Mar 2023
- First submitted
- 30 Jan 2021
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility and Accuracy of a Wireless Vital Sign Monitor for Observation of Adult Patients in Uganda
- ClinicalTrials.gov ID
- NCT04761432
- Acronym / sponsor ID
- MakSPH/HDREC/910
- Conditions
- Critical Illness
- Keywords
- Critical care, Health technology, Vital sign monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Neopenda, PBCIndustry (pharma, biotech, devices)
- Collaborators
- Makerere University
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: neoGuardThirty (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neoGuardNeoGuard is a wireless wearable vital signs monitor that continuously measures temperature, pulse rate, respiratory rate and oxygen saturation. | Device | Intervention arm |
Primary outcome
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.
1 secondary outcome
Feasibility success of the wireless vital sign monitor
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Kiwanuka principal investigator
Makerere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neoGuard in people with Critical Illness, run by Neopenda, PBC at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy limits for pulse rate, oxygen saturation, respiratory rate and temperature (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.