Evaluation of ExSpiron™ Measurements Derived Without Patient Specific Calibration

Completed

• Conditions: Non-Invasive Respiratory Volume Monitoring

• Registration Number: NCT02690298
• Lead Sponsor: Respiratory Motion, Inc.

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

Detailed Description

In order to evaluate the performance of the device under the range of conditions encountered in the clinical environment, the respiratory volume monitor (RVM) was tested throughout a range of respiratory rates and also during erratic breathing patterns. At 4 and 36 breaths per minute (the extremes of the rates anticipated to be encountered in the clinical setting), and during erratic breathing, RVM and spirometry measurements were found to be highly-correlated (r=0.98 ±0.01 (mean ±95%CI) at 4 breaths/min, 0.97 ±0.01 at 36, and 0.93 ±0.04 during erratic breathing). These studies also included calibration of the ExSpiron to the spirometer.

The primary objective of the study is to compare the minute ventilation (MV), tidal volume (TV) and respiratory rate (RR) measurements collected and reported by the ExSpiron, without prior ExSpiron calibration, against acquired MV, TV, and RR measurements from an ExSpiron with prior individual specific calibration to a spirometer using either a Wright Spirometer or a Morgan Flow Volume Loop (FVL) Pneumotachograph Spirometer. A secondary objective will be to confirm the PadSet functionality after 24 hours of wear in accordance with current labeling.

Study Timeline

• Study Start: 2015-09-01
• Study First Submitted: 2015-09-08
• Study First Submitted QC: 2016-02-18
• Study First Posted: 2016-02-24
• Primary Completion: 2016-04-30
• Study Completion: 2016-04-30
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	3 months	Calibrated ExSpiron measurements compared against uncalibrated ExSpiron measurements
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	3 months	Calibrated ExSpiron measurements compared against uncalibrated ExSpiron measurements
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	3 months	Calibrated ExSpiron measurements compared against uncalibrated ExSpiron measurements