Clinical trial NCT04179279: Comparative Analysis of a Non-contact Respiratory and Heart Rate Monitor Vs. a Conventional Clinically Validated Reference Monitor
Official title: Comparative Analysis of a Non-contact Respiratory and Heart Rate Monitor Vs. a Conventional Clinically Validated Reference Monitor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Rate
Respiratory Rate
Lead sponsor: ContinUse Biometrics Ltd.
Sponsor class: INDUSTRY
First posted: 2019-11-27
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted/visiting the cardiology ward and/or outpatient clinics for various indications

Brief summary: This is a prospective pivotal study in patients admitted/visiting the cardiology ward and/or outpatient clinics for various indications.

The study will be conducted in two stages. The first stage will comprise a pilot study with 10 subjects, which will be completed and analyzed prior to initiation of the second stage. The two studies are independent and are included in the same protocol for logistical reasons. The second stage of the study, which will include 120 subjects, is pivotal and intended to validate the Gili BioSensor System.

Testing procedure will include seating the subject in either a steady chair in front of a table, or in bed with the bedrest raised in front of a cardiac table (or similar). The subject will be seated for 5 minutes to reach a physiological steady state. During this time, the subject will be connected to the reference device according to the manufacturer's guidelines. The investigational device will be placed on a stable surface in front of the subject (table / cardiac table or similar) and will point to the left side of the subject's chest. Both the investigational and reference devices will be temporally synchronized to maintain coordinated recording. Following the 5-minute resting period, both investigational and reference devices will be activated for a comparative recording session to acquire at least 180 seconds (3 minutes) of evaluable data. Each 60-sec interval will be used separately for comparative analyses.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18, male or female
* Hemodynamically stable as assessed by the investigator
* Willing and able to sign informed consent

Exclusion Criteria:

* Inability to consent/comply with study protocol
* Presence of a condition that may interfere with the devices' performance (e.g. nausea, vomiting, persistent coughing, tremor, mouth breathing, etc.)
* Use of reflective garment, (e.g. sequin, silk, or similar), or highly textured garments (e.g. fur, thick lace, shaggy wool etc.).
* Parallel participation in another clinical trial

Primary outcomes:
measure: Heart rate
timeFrame: During the procedure
measure: Respiratory rate
timeFrame: During the procedure
Secondary outcomes:
measure: Safety evaluation
timeFrame: During the procedure
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center (TASMC)
Study officials:
References: