Loop Band Validation Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-21

Study Completion Date

2018-01-25

Brief Summary

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

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Detailed Description

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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.

Conditions

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COPD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Loop Band

Measure accuracy of vital sign measurements

Group Type EXPERIMENTAL

Loop Band

Intervention Type DEVICE

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

Interventions

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Loop Band

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes