Evaluation of SenseGuard™- a Noninvasive Respiratory Rate Measuring Device

NCT03964675 | Completed

• 1 other identifier: 0137-18-NHR
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Condition

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Usability (comfort and easiness) score of the SenseGuard™ system as measured by a questionnaire completed by the subjects

  4 months

Study Arms (1)

Respiratory rate measurement

EXPERIMENTAL

Simultaneous measurement of respiratory rate using SenseGuard and Capnography

Device: SenseGuard

Interventions

SenseGuard DEVICE

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

Respiratory rate measurement

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NanoVation: lead

Study Sites (1)

Galilee Medical Center

Nahariya, 22100, Israel

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: May 22, 2019
• First Posted: May 28, 2019
• Study Start: January 13, 2019
• Primary Completion: April 8, 2019
• Study Completion: April 8, 2019
• Last Updated: May 28, 2019

Record last verified: 2019-05

Locations

IL (1)