Loop Band Validation Study

Not Applicable

Completed

• Conditions: COPD
• Interventions: Device: Loop Band

• Registration Number: NCT03240926
• Lead Sponsor: Spry Health

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2017-02-21
• Study First Submitted: 2017-08-01
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-07
• Primary Completion: 2018-01-22
• Study Completion: 2018-01-25
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-14
• Last Update Posted: 2018-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Loop Band	Loop Band	Measure accuracy of vital sign measurements

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	intraoperative	Evaluate safety data based on reported Adverse Events (AEs).

Trial Locations

Locations (1)

Huntington Memorial Hospital; 🇺🇸 Pasadena, California, United States