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Evaluation of SenseGuard™- a Noninvasive Respiratory Rate Measuring Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03964675
Recruitment Status : Completed
First Posted : May 28, 2019
Last Update Posted : May 28, 2019
Information provided by (Responsible Party):

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Condition Device: SenseGuard Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of SenseGuard™ - a Noninvasive Respiratory Rate Measuring Device for Adult Patients
Actual Study Start Date : January 13, 2019
Actual Primary Completion Date : April 8, 2019
Actual Study Completion Date : April 8, 2019

Arm Intervention/treatment
Experimental: Respiratory rate measurement
Simultaneous measurement of respiratory rate using SenseGuard and Capnography
Device: SenseGuard
A single invitational visit with a respiratory rate measurement duration of 30 minutes.

Primary Outcome Measures :
  1. Accuracy of Respiratory Rate (RR) as measured by the SenseGuard™ system versus the gold standard (capnography). [ Time Frame: 4 months ]
  2. Frequency and incidence of any adverse events and serious adverse events related and unrelated to the device use [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Usability (comfort and easiness) score of the SenseGuard™ system as measured by a questionnaire completed by the subjects [ Time Frame: 4 months ]
    The easiness and comfort shall be evaluated using a questionnaire that includes 5 questions with possible scores ranging from 1(worst)-5(best)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Hospitalized patients from the Internal/General wards.
  2. Provision of signed and dated informed consent form
  3. Stated willingness to comply with all study procedures and availability for the duration of the study
  4. Male or female, aged ≥18
  5. Willing to adhere to the study regimen

Exclusion Criteria:

  1. Intubated patients (i.e. endobronchial intubation) or patients currently undergoing a BPAP/CPAP treatment.
  2. Presence of implanted electronic device intended to regulate cardiac activity (e.g., pacemaker or cardioverter/defibrillator)
  3. Pregnancy or lactation
  4. 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.
  5. Participation in another study in the last 4 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03964675

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Galilee Medical Center
Nahariya, Israel, 22100
Sponsors and Collaborators
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Responsible Party: NanoVation Identifier: NCT03964675    
Other Study ID Numbers: 0137-18-NHR
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No