Track topics on Twitter Track topics that are important to you
The primary purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the Spire Medical Health Tag to a FDA cleared End Tidal Carbon Dioxide monitor Reference Standard (GE Datex-Ohmeda).
After IRB approval, a minimum of 20 healthy volunteer test subjects, 18 or older will be entered into this study designed to validate the accuracy of the respiratory rate feature of the Spire Medical Health Tag (Device Under Test).
The subjects will be selected to represent a range of body types including small, average, muscular, and large with a range of BMIs. Each subject will be connected to a FDA cleared EtCO2 monitor (GE Datex-Ohmeda) and will be instrumented with a mouthpiece or open system mask that allows for measurement of EtCO2 derived respiratory rate. A range of stable respiratory rates will be elicited from each volunteer test subject with the use of a paced breathing application on a mobile phone. Subjects will also be connected to a 3-lead ECG (GE Datex-Ohmeda) for the purpose of monitoring heart rate and comparing to the pulse rate measurements recorded by the Spire Medical Health Tag.
The respiratory rate and pulse rate will be measured simultaneously for the Reference and the Device Under Test.
The purpose of this study is to collect data to validate the respiratory rate performance of the Medical Health Tag developed by Spire Health. The Medical Health Tag respiratory rate will be evaluated during non-motion conditions over the range a range of 5-50 breaths per minute via Reference EtCO2. A FDA cleared, GE Healthcare S5 Multi-parameter monitoring system with End Tidal Carbon Dioxide (EtCO2) and 3-lead ECG will be used for the Respiratory and Pulse Rate References. There are no risks or adverse device effects to be assessed. There are no contraindications for use in the proposed study / study population.
This study will focus on the respiratory rate, RR parameter. The Spire Medical Health Tag is investigational and has not been cleared by the FDA. The intended purpose of the device under test is spot-checking, non-invasive monitoring / logging of respiratory rate on humans. For this evaluation, the device will be run in a continuous data collection mode.
The study population will include 20 healthy competent adults, ages 18 years and older. The subject selection will be a mix of males and females with small to large physiques. The subjects must understand the study and consent to participate by signing the Informed Consent Form. The subjects must be healthy showing no evidence of medical problems as indicated by satisfactorily completing the health assessment form and passing the health screening. Eligible subjects need to meet all of the inclusion criteria and none of the exclusion criteria for participation.
It is expected that the data collection will take approximately 4-7 days to complete. There is no additional followup required for the investigation.
The data from the Device Under Test will be collected on an application installed on the iOS or Android mobile device separate from the reference equipment.
Multi-parameter monitor used during the study to observe a subject's vital signs include ECG tracing, heart rate, respiratory rate, and EtCO2 with capnograph.
- GE Healthcare S5 Compact Monitor, M-NESTPR module with ECG, and/or Multi-parameter monitor
- Portable oxygen tank, mask and ambu bag
- GE Healthcare (Datex-Ohmeda) 3900 TruTrak+ / OxyTip+ Oxy-F-UN or Oxy-AF Sensor and Oxy-OL3 cable (SpO2 monitoring)
- Blood pressure cuff and stethoscope
Currently the FDA defines respiration rate devices as Class II devices. The Device Under Test in this study is considered non-significant risk device.
There are no risks or adverse device effects to be assessed. There are no contraindications for use in the proposed study / study population.
Spire Medical Health Tag
Not yet recruiting
Published on BioPortfolio: 2019-10-01T07:55:04-0400
The purpose of this study is to collect data to validate the step- (actigraphy) and sleep-tracking performance of the Medical Health Tag device developed by Spire Health.
The purpose of this study is to compare the treatment effect of three treatment regimens of HDM-SPIRE vs placebo and to evaluates the treatment effect of HDM-SPIRE on symptoms, rescue medi...
The purpose of this study is to evaluate the safety and tolerability of multiple administrations of Birch-SPIRE. To make a preliminary assessment on pharmacodynamic parameters and clinical...
The purpose of this study is to determine whether it is safe to administer Grass-SPIRE to subjects suffering from both grass allergy and asthma
The goal of this study is to evaluate the effectiveness of Spire and Muse on stress management. The study will be implemented as a 2-arm randomized controlled pilot study to assess the eff...
The relationship between increase in body temperature, heart rate, and respiratory rate has only been studied in young, healthy subjects.
The present study addresses the problem of estimating the respiratory rate from the morphological ECG variations in the presence of atrial fibrillatory waves (f-waves). The significance of performing ...
The medical management of chronic respiratory diseases becomes more difficult with the increase in the rate of the elderly population. Monitoring and treating chronic respiratory diseases at home are ...
The actin nucleators Spire and Cappuccino synergize to promote actin assembly, but the mechanism of their synergy is controversial. Together these proteins promote the formation of actin meshes, which...
A health care system which combines physicians, hospitals, and other medical services with a health plan to provide the complete spectrum of medical care for its customers. In a fully integrated system, the three key elements - physicians, hospital, and health plan membership - are in balance in terms of matching medical resources with the needs of purchasers and patients. (Coddington et al., Integrated Health Care: Reorganizing the Physician, Hospital and Health Plan Relationship, 1994, p7)
Part of the brain located in the MEDULLA OBLONGATA and PONS. It receives neural, chemical and hormonal signals, and controls the rate and depth of respiratory movements of the DIAPHRAGM and other respiratory muscles.
The signs of life that may be monitored or measured, namely pulse rate, respiratory rate, body temperature, and blood pressure.
Professions or other business activities directed to the cure and prevention of disease. For occupations of medical personnel who are not physicians but who are working in the fields of medical technology, physical therapy, etc., ALLIED HEALTH OCCUPATIONS is available.
An operating division of the US Department of Health and Human Services. It is concerned with the overall planning, promoting, and administering of programs pertaining to health and medical research. Until 1995, it was an agency of the United States PUBLIC HEALTH SERVICE.
Asthma COPD Cystic Fibrosis Pneumonia Pulmonary Medicine Respiratory Respiratory tract infections (RTIs) are any infection of the sinuses, throat, airways or lungs. They're usually caused by viruses, but they can also ...