Non-invasive Tidal Volume Monitoring Using the Linshom Respiratory Monitoring Device



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:12/3/2017
Start Date:September 2017
End Date:December 2017
Contact:Madhankumar Sathyamoorthy, MBBS, MS
Email:msathyamoorthy@umc.edu
Phone:603-566-4660

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Many post-operative complications arise from patients who breathe inadequately. Inadequate
respiration, whether the result of surgery or the anesthesia, causes a decrease in blood
oxygen saturation and an increase in carbon dioxide partial pressure. Both of these surrogate
measurements of respiration may pose a challenge to measure. Some administer exogenous oxygen
to all patients as they leave the operating room in order to maintain the blood oxygen
saturation. This renders the oximeter a less sensitive metric of depressed respiration. In
the face of decreased respiration, the carbon dioxide levels continue to increase slowly and
often go undetected unless blood gases are measured. Indeed carbon dioxide blood levels are
the only metric to detect inadequate ventilation using this surrogate index.

Monitoring ventilation is a serious challenge outside of critical care settings. In fact,
there are no monitors available that can measure tidal volume or relative tidal volume
outside of these settings.

Linshom is a novel instrument that tracks relative respiration by measuring the excursions of
the temperature swings between inspiration and expiration and normalizing them to the
patient's breathing. This monitor may be the first non-invasive monitor to measure relative
tidal volume in non-critical care settings.

The purpose of this study is to determine whether a non-invasive, temperature-based
respiratory instrument can track tidal volume (Vt) in patients.

The investigators hypothesize that the Linshom device can accurately and consistently track
tidal volume as measured by closed loop mechanical ventilator.

Forty volunteers will be enrolled in this open label, prospective study to determine the
correlation between the tidal volumes measured with the Linshom detector and those measured
with the mechanical ventilator. after Institutional Review Board (IRB) approval and written
informed consent from the volunteers.

The Linshom detector, which is comprised of two rapid responding medical-grade thermistors in
close proximity to the mouth/nose (sensor) and a thermistor remote to the airway, will be
mounted in the continuous positive airway pressure (CPAP) face mask to measure the
temperature during breathing. The CPAP will be connected to a Servo-I ventilator (Maquet)
with a circuit and disposable filter. The volunteers will be instructed to breathe normal
through the CPAP mask on room air. The excursions of the thermistor tracings (from valley to
peak) will be recorded by the Linshom device and displayed continuously on a laptop monitor
in a waveform. The tidal volume will also be measured by the ventilator and the data
downloaded in a Compact Flash card. The temperature profiles from the sensors and the
relative tidal volume will be correlated with the tidal volumes measured by the ventilator.

Inclusion Criteria:

- healthy

Exclusion Criteria:

- pregnant

- suffer from claustrophobia

- had recent respiratory illness

- had recent gastrointestinal illness

- unable to provide informed consent
We found this trial at
1
site
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Madhankumar Sathyamoorthy, MBBS, MS
Phone: 603-566-4660
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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from
Jackson, MS
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