Evaluation of SenseGuard™- a Noninvasive Respiratory Rate Measuring Device

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.

Study Overview

• Status: Completed
• Conditions: Condition
• Intervention / Treatment: Device: SenseGuard

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:

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

Participant Duration:

A single invitational visit with a respiratory rate measurement duration of 30 minutes

Study Duration:

1 year.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Nahariya, Israel, 22100
    • Galilee Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	4 months

Collaborators and Investigators

• Sponsor: NanoVation

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2019
• Primary Completion (Actual): April 8, 2019
• Study Completion (Actual): April 8, 2019

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (Actual): May 28, 2019

Study Record Updates

• Last Update Posted (Actual): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 24, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 0137-18-NHR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No