Loop Band Validation Study

Spry Health

Status

Completed

Conditions

COPD

Treatments

Device: Loop Band

Study type

Interventional

Funder types

Industry

Identifiers

NCT03240926

32315

Details and patient eligibility

About

The main purpose of this study is to assess the accuracy of a non-invasive wearable technology in the form of a wristband.

Full description

The main purpose of this study is to assess the accuracy of a non-invasive wearable technology in the form of a wristband. This wristband (Loop Band) uses optical sensors and spectrometry to measure and estimate vitals as well as a full blood gas panel; comparable to the standard method of an invasive arterial line and pressure transducer. The investigators aim to show equivalence of clinical physiologic outcome measurements with the Loop Band relative to current methods (i.e. arterial lines, etc.). In addition, this study aims to validate this wearable technology as a potential alternative to invasive measurements, to reduce complications, and improve accuracy in regards to patient monitoring.

Enrollment

235 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patient has capacity to consent for the study.
Anesthetic plan for an arterial line for vital sign monitoring during their surgical procedure.

Exclusion criteria

Active Atrial Fibrillation
Active C-difficile
Amputation of the arm at the wrist or above
The Investigator and/or Clinical Research Nurse will conduct a visual inspection for attributes that may diminish device accuracy. These include but are not limited to: tattoos over the radial artery, burns or heavy scarring over the radial artery, fragile skin, any skin diseases affecting the wrist or arm, Physician discretion-any condition deemed inappropriate that will preclude use of the device.