Loop Band Validation Study

COPD Clinical Trial

Official title:

Loop Band Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03240926
• Other study ID #: 32315
• Status: Completed
• Phase: N/A
• Start date: February 21, 2017
• Est. completion date: January 25, 2018

Study information

• Verified date: June 2018
• Source: Spry Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: January 25, 2018
• Est. primary completion date: January 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD

Intervention

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

Locations

Country	Name	City	State
United States	Huntington Memorial Hospital	Pasadena	California

Sponsors (1)

Lead Sponsor	Collaborator
Spry Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	intraoperative
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Evaluate safety data based on reported Adverse Events (AEs).	intraoperative