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

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ClinicalTrials.gov Identifier: NCT03279458
Recruitment Status : Completed
First Posted : September 12, 2017
Results First Posted : July 4, 2018
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Madhankumar Sathyamoorthy, University of Mississippi Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pulmonary Ventilation Capnography Device: Linshom Respiratory Monitoring Device Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-invasive Tidal Volume Monitoring Using the Linshom Respiratory Monitoring Device
Actual Study Start Date : September 8, 2017
Actual Primary Completion Date : September 8, 2017
Actual Study Completion Date : September 8, 2017

Arm Intervention/treatment
Experimental: Linshom Respiratory Monitoring Device
Volunteers will breathe through a continuous positive airway pressure (CPAP) face mask fitted with the Linshom device. 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.
Device: Linshom Respiratory Monitoring Device
Volunteers will breathe through a continuous positive airway pressure (CPAP) face mask fitted wth the Linshom device. 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.

Active Comparator: Ventilator
Volunteers will breathe through a continuous positive airway pressure (CPAP) face mask fitted with the Linshom device. The volunteers will be instructed to breathe normal through the CPAP mask on room air.The tidal volume will also be measured by the ventilator and the data downloaded in a Compact Flash card.
Device: Linshom Respiratory Monitoring Device
Volunteers will breathe through a continuous positive airway pressure (CPAP) face mask fitted wth the Linshom device. 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.




Primary Outcome Measures :
  1. Tidal Volume of Each Breath Was Measured Using the Same Breathing Mask CPAP Apparatus Combined With Respiratory Monitoring Device Allowing for Simultaneous Recording. [ Time Frame: 5 minutes ]
    Tidal volume measured by CPAP mask with Lishom respiratory monitoring device. Tidal volume determined from the ventilator will be compared to tidal volume measured by Linshom (calculated indirectly by temperature changes by computer algorithm)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy

Exclusion Criteria:

  • pregnant
  • suffer from claustrophobia
  • had recent respiratory illness
  • had recent gastrointestinal illness
  • unable to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279458


Locations
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United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
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Principal Investigator: Madhankumar Sathyamoorthy, MBBS, MS Children's of Mississippi/University of Mississippi Medical Center
  Study Documents (Full-Text)

Documents provided by Madhankumar Sathyamoorthy, University of Mississippi Medical Center:

Additional Information:
Publications:

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Responsible Party: Madhankumar Sathyamoorthy, Associate Professor, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT03279458     History of Changes
Other Study ID Numbers: 2017-0063
First Posted: September 12, 2017    Key Record Dates
Results First Posted: July 4, 2018
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Madhankumar Sathyamoorthy, University of Mississippi Medical Center:
Capnography