Loop Band Validation Study

Spry Health235 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

235

Conditions

COPD

Interventions

Loop BandDEVICE

Application of Loop band on radial artery of the opposite wrist that the Anesthesiologist has placed the Arterial line.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Huntington Memorial Hospital

Pasadena, California, United States

Outcomes

Primary Outcomes

Device Equivalence in clinical outcome measures (heart rate, blood oxygenation, carboxyhemoglobin level, end tidal carbon dioxide, and respiratory rate) measured by Arterial Line.

Equivalence in clinical outcome measures (heart rate, blood oxygenation, carboxyhemoglobin level, end tidal carbon dioxide, and respiratory rate etc.) with the Loop Band relative to current methods (i.e. arterial lines, etc.) during a surgical procedure.

Time frame: intraoperative

Secondary Outcomes

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Evaluate safety data based on reported Adverse Events (AEs).

Time frame: intraoperative

Data from ClinicalTrials.gov

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