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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

Tracking Information
First Submitted Date  ICMJE September 6, 2017
First Posted Date  ICMJE September 12, 2017
Results First Submitted Date  ICMJE October 24, 2017
Results First Posted Date  ICMJE July 4, 2018
Last Update Posted Date July 4, 2018
Actual Study Start Date  ICMJE September 8, 2017
Actual Primary Completion Date September 8, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2018)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
Tidal volume of each breath [ Time Frame: 5 minutes ]
Tidal volume measured by the ventilator will be compared to tidal volume measured by Linshom (calculated indirectly by temperature changes by computer algorithm)
Change History Complete list of historical versions of study NCT03279458 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Non-invasive Tidal Volume Monitoring Using the Linshom Respiratory Monitoring Device
Official Title  ICMJE Non-invasive Tidal Volume Monitoring Using the Linshom Respiratory Monitoring Device
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Pulmonary Ventilation
  • Capnography
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Linshom Respiratory Monitoring Device
  • 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.
    Intervention: Device: Linshom Respiratory Monitoring Device
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 8, 2017
Actual Primary Completion Date September 8, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy

Exclusion Criteria:

  • pregnant
  • suffer from claustrophobia
  • had recent respiratory illness
  • had recent gastrointestinal illness
  • unable to provide informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03279458
Other Study ID Numbers  ICMJE 2017-0063
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan to share IPD
Responsible Party Madhankumar Sathyamoorthy, University of Mississippi Medical Center
Study Sponsor  ICMJE University of Mississippi Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Madhankumar Sathyamoorthy, MBBS, MS Children's of Mississippi/University of Mississippi Medical Center
PRS Account University of Mississippi Medical Center
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP