Completed

NCT Number: NCT02690298

Evaluation of ExSpiron™ Measurements Derived Without Patient Specific Calibration

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

Completed

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Key information

Conditions

Non-Invasive Respiratory Volume Monitoring

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ExSpiron

Device

Non-Invasive respiratory volume monitoring

Other names: RVM

Primary outcomes

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

Time frame: 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

Time frame: 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

Time frame: 3 months

Calibrated ExSpiron measurements compared against uncalibrated ExSpiron measurements

Sponsors and collaborators

Lead sponsor

Respiratory Motion, Inc.

Industry

Registry information

Official study title

Evaluation of ExSpiron™ Non-Invasive Respiratory Volume Monitor Measurements Derived Without Patient Specific Calibration

Acronym: RMI UVU

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Feb 24, 2016
Registry last updated: Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.