ConditionNCT03964675
Evaluation of SenseGuard™- a Noninvasive Respiratory Rate Measuring Device
A study testing SenseGuard in people with Condition, run by NanoVation at 1 site in Israel.
Trial summary
The SenseGuard™ is a new respiratory rate measuring and logging non-invasive device, and measures the respiratory rate by responding to changes in air moisture content in exhaled air. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Condition
- What is being tested?
- SenseGuard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- 13 Jan 2019to 8 Apr 2019
- 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
- Hospitalized patients from the Internal/General wards.
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥18
- Willing to adhere to the study regimen
Who cannot join
- Intubated patients (i.e. endobronchial intubation) or patients currently undergoing a BPAP/CPAP treatment.
- Presence of implanted electronic device intended to regulate cardiac activity (e.g., pacemaker or cardioverter/defibrillator)
- Pregnancy or lactation
- Known allergic reactions to materials used in the components of the SenseGuard™ system, i.e. polyethylene or silicon, or gold, nickel, copper or alloys containing any of the above.
- Participation in another study in the last 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of SenseGuard™ - a Noninvasive Respiratory Rate Measuring Device for Adult Patients
The SenseGuard™ is a new respiratory rate measuring and logging non-invasive device, and measures the respiratory rate by responding to changes in air moisture content in exhaled air. A prospective single-center, single arm study, designed to assess the bias, accuracy , precision and safety of the SenseGuard™ device in measuring of respiratory rate in adult patients. The study shall include a single invitational visit with a respiratory rate measurement duration of 30 minutes for each of 25 adult subjects hospitalized in internal wards.Subjects will be invited to participate should they meet all of the eligibility criteria. Following informed consent, subjects will be measured with both Microstream capnograph and SenseGuard™ measuring simultaneously so their results can be compared.
Read the detailed description
Study description:
Respiratory rate (RR) is a vital sign used to monitor clinical condition of a patient. It is defined as the number of breaths per minute. Various devices using different techniques are available to measure RR. Currently this is measured at the bedside in clinical practice by counting the breaths, however the gold standard for measuring this vital sign is the capnograph. For the patient, this involves limiting the movement and talking so that the measurements can be taken.
A new respiratory rate measuring and logging device, SenseGuard™, is non-invasive and measures the respiratory rate by responding to changes in air moisture content (small amounts of water condensation) in exhaled air.
The study is planned as a prospective single-center, single arm study, designed to assess the bias, accuracy , precision and safety of the SenseGuard™ non-invasive device in measuring of respiratory rate in adult patients.
Subjects will be invited to participate should they meet all of the eligibility criteria. Following informed consent, subjects will be measured with both Microstream capnograph and SenseGuard™ measuring simultaneously so their results can be compared.
Study population:
25 hospitalized patients from Internal/General wards aged 18 and older.
Objective:
Evaluate the performance and safety of the SenseGuard™ non-invasive device in measuring respiratory rate in hospitalized adult patients.
Inclusion Criteria:
- Hospitalized patients from the Internal/General wards.
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥18
- Willing to adhere to the study regimen
Exclusion Criteria:
- Intubated patients (i.e. endobronchial intubation) or patients currently undergoing a BPAP/CPAP treatment.
- Presence of implanted electronic device intended to regulate cardiac activity (e.g., pacemaker or cardioverter/defibrillator)
- Pregnancy or lactation
- Known allergic reactions to materials used in the components of the SenseGuard™ system, i.e. polyethylene or silicon, or gold, nickel, copper or alloys containing any of the above.
- Participation in another study in the last 4 weeks
Participant Duration:
A single invitational visit with a respiratory rate measurement duration of 30 minutes
Study Duration:
1 year.
- Conditions
- Condition
- Being tested
- SenseGuard
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SenseGuardDevice
A single invitational visit with a respiratory rate measurement duration of 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory rate measurement | Experimental | Simultaneous measurement of respiratory rate using SenseGuard and Capnography Receives: Device: SenseGuard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Respiratory Rate (RR) as measured by the SenseGuard™ system versus the gold standard (capnography).
Measured: 4 months
Frequency and incidence of any adverse events and serious adverse events related and unrelated to the device use
Measured: 4 months
Secondary outcomes (1)
Usability (comfort and easiness) score of the SenseGuard™ system as measured by a questionnaire completed by the subjects
The easiness and comfort shall be evaluated using a questionnaire that includes 5 questions with possible scores ranging from 1(worst)-5(best)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start13 Jan 2019
- Primary completion8 Apr 2019
- Study completion8 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConditionStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- NanoVation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964675
- Sponsor's protocol ID
- 0137-18-NHR
- Status last verified
- May 2019
- First submitted
- 22 May 2019
- Last updated
- 28 May 2019
- 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 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SenseGuard™ - a Noninvasive Respiratory Rate Measuring Device for Adult Patients
- ClinicalTrials.gov ID
- NCT03964675
- Acronym / sponsor ID
- 0137-18-NHR
- Conditions
- Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- NanoVationIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2019 (actual)
- Primary completion
- 8 Apr 2019 (actual)
- Study completion
- 8 Apr 2019 (actual)
- First posted
- 28 May 2019 (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.
The SenseGuard™ is a new respiratory rate measuring and logging non-invasive device, and measures the respiratory rate by responding to changes in air moisture content in exhaled air. A prospective single-center, single arm study, designed to assess the bias, accuracy , precision and safety of the SenseGuard™ device in measuring of respiratory rate in adult patients. The study shall include a single invitational visit with a respiratory rate measurement duration of 30 minutes for each of 25 adult subjects hospitalized in internal wards.Subjects will be invited to participate should they meet all of the eligibility criteria. Following informed consent, subjects will be measured with both Microstream capnograph and SenseGuard™ measuring simultaneously so their results can be compared.
Detailed description
Study description:
Respiratory rate (RR) is a vital sign used to monitor clinical condition of a patient. It is defined as the number of breaths per minute. Various devices using different techniques are available to measure RR. Currently this is measured at the bedside in clinical practice by counting the breaths, however the gold standard for measuring this vital sign is the capnograph. For the patient, this involves limiting the movement and talking so that the measurements can be taken.
A new respiratory rate measuring and logging device, SenseGuard™, is non-invasive and measures the respiratory rate by responding to changes in air moisture content (small amounts of water condensation) in exhaled air.
The study is planned as a prospective single-center, single arm study, designed to assess the bias, accuracy , precision and safety of the SenseGuard™ non-invasive device in measuring of respiratory rate in adult patients.
Subjects will be invited to participate should they meet all of the eligibility criteria. Following informed consent, subjects will be measured with both Microstream capnograph and SenseGuard™ measuring simultaneously so their results can be compared.
Study population:
25 hospitalized patients from Internal/General wards aged 18 and older.
Objective:
Evaluate the performance and safety of the SenseGuard™ non-invasive device in measuring respiratory rate in hospitalized adult patients.
Inclusion Criteria:
- Hospitalized patients from the Internal/General wards.
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥18
- Willing to adhere to the study regimen
Exclusion Criteria:
- Intubated patients (i.e. endobronchial intubation) or patients currently undergoing a BPAP/CPAP treatment.
- Presence of implanted electronic device intended to regulate cardiac activity (e.g., pacemaker or cardioverter/defibrillator)
- Pregnancy or lactation
- Known allergic reactions to materials used in the components of the SenseGuard™ system, i.e. polyethylene or silicon, or gold, nickel, copper or alloys containing any of the above.
- Participation in another study in the last 4 weeks
Participant Duration:
A single invitational visit with a respiratory rate measurement duration of 30 minutes
Study Duration:
1 year.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory rate measurement | Experimental | Device: SenseGuardSimultaneous measurement of respiratory rate using SenseGuard and Capnography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hospitalized patients from the Internal/General wards.
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥18
- Willing to adhere to the study regimen
Key exclusion criteria (5 listed)
- Intubated patients (i.e. endobronchial intubation) or patients currently undergoing a BPAP/CPAP treatment.
- Presence of implanted electronic device intended to regulate cardiac activity (e.g., pacemaker or cardioverter/defibrillator)
- Pregnancy or lactation
- Known allergic reactions to materials used in the components of the SenseGuard™ system, i.e. polyethylene or silicon, or gold, nickel, copper or alloys containing any of the above.
- Participation in another study in the last 4 weeks
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 |
|---|---|---|
| SenseGuardA single invitational visit with a respiratory rate measurement duration of 30 minutes. | Device | Respiratory rate measurement |
Primary outcome
Accuracy of Respiratory Rate (RR) as measured by the SenseGuard™ system versus the gold standard (capnography).
Time frame: 4 months
Frequency and incidence of any adverse events and serious adverse events related and unrelated to the device use
Time frame: 4 months
1 secondary outcome
Usability (comfort and easiness) score of the SenseGuard™ system as measured by a questionnaire completed by the subjects
Time frame: 4 months
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 28 May 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SenseGuard in people with Condition, run by NanoVation at 1 site in Israel.
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 5 inclusion and 5 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 28 May 2019. 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 Israel. 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 of Respiratory Rate (RR) as measured by the SenseGuard™ system versus the gold standard (capnography). (time frame: 4 months). The study lists 2 primary outcomes in all. 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 28 May 2019.