Evaluation of ExSpiron™ Measurements Derived Without Patient Specific Calibration

NCT02690298 | Completed DMC

• 1 other identifier: RMI UVU 2015-0052
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

Previous studies have shown that the ExSpiron™ can provide non-invasive, real-time, accurate measurements of minute ventilation (MV), tidal volume (TV) and respiratory rate (RR) after calibration with a spirometer. The purpose of this study is to compare the MV, TV and RR values measured by the ExSpiron™ without prior spirometer calibration to values obtained with a spirometer calibration. In this study, the MV and TV values will be compared between the ExSpiron™ with and without prior patient-specific calibration of the ExSpiron™ to a spirometer

Conditions

Non-Invasive Respiratory Volume Monitoring

Outcome Measures

Primary Outcomes (3)

• The primary outcome measure of the study is the minute ventilation (MV), in liters per minute (L/min), collected and reported by the ExSpiron, with and without prior ExSpiron calibration

  Calibrated ExSpiron measurements compared against uncalibrated ExSpiron measurements

  3 months

• The primary outcome measure of the study is the tidal volume (TV), in liters (L), collected and reported by the ExSpiron, with and without prior ExSpiron calibration

  Calibrated ExSpiron measurements compared against uncalibrated ExSpiron measurements

  3 months

• The primary outcome measure of the study is the respiratory rate (RR), in breaths per minute (bpm), collected and reported by the ExSpiron, with and without prior ExSpiron calibration

  Calibrated ExSpiron measurements compared against uncalibrated ExSpiron measurements

  3 months

Interventions

ExSpiron DEVICE

Non-Invasive respiratory volume monitoring

Also known as: RVM

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Respiratory measurements will be acquired from up to 100 subjects from a wide cross-section of the adult population. Potential subjects will be screened based on the following inclusion/exclusion criteria to determine eligibility.

You may qualify if:

• Males and Females aged 21-90
• Able to provide written informed consent
• Able to participate in a two day study

You may not qualify if:

• Men and Women aged \<21 years and \>90 years of age
• Inability to follow study and/or study staff instructions
• Inability to perform study procedures, e.g. spirometry
• Allergy to the electrodes or components of the electrodes

Sponsors & Collaborators

• Respiratory Motion, Inc.: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: February 24, 2016
• Study Start: September 1, 2015
• Primary Completion: April 30, 2016
• Study Completion: April 30, 2016
• Last Updated: August 28, 2018

Record last verified: 2018-08