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

NCT03279458 | Completed Results FDA Device

• 1 other identifier: 2017-0063
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Ventilation; Capnography

Keywords

Capnography

Outcome Measures

Primary Outcomes (1)

• Tidal Volume of Each Breath Was Measured Using the Same Breathing Mask CPAP Apparatus Combined With Respiratory Monitoring Device Allowing for Simultaneous Recording.

  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)

  5 minutes

Study Arms (2)

Linshom Respiratory Monitoring Device

EXPERIMENTAL

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

Ventilator

ACTIVE COMPARATOR

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

Interventions

Linshom Respiratory Monitoring Device 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.

Linshom Respiratory Monitoring Device; Ventilator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy

You may not qualify if:

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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (8)

• Manifold CA, Davids N, Villers LC, Wampler DA. Capnography for the nonintubated patient in the emergency setting. J Emerg Med. 2013 Oct;45(4):626-32. doi: 10.1016/j.jemermed.2013.05.012. Epub 2013 Jul 18.

  PMID: 23871325 BACKGROUND

• Brouillette RT, Morrow AS, Weese-Mayer DE, Hunt CE. Comparison of respiratory inductive plethysmography and thoracic impedance for apnea monitoring. J Pediatr. 1987 Sep;111(3):377-83. doi: 10.1016/s0022-3476(87)80457-2.

  PMID: 3625404 BACKGROUND

• Ramsay MA, Usman M, Lagow E, Mendoza M, Untalan E, De Vol E. The accuracy, precision and reliability of measuring ventilatory rate and detecting ventilatory pause by rainbow acoustic monitoring and capnometry. Anesth Analg. 2013 Jul;117(1):69-75. doi: 10.1213/ANE.0b013e318290c798. Epub 2013 Apr 30.

  PMID: 23632055 BACKGROUND

• Keidan I, Gravenstein D, Berkenstadt H, Ziv A, Shavit I, Sidi A. Supplemental oxygen compromises the use of pulse oximetry for detection of apnea and hypoventilation during sedation in simulated pediatric patients. Pediatrics. 2008 Aug;122(2):293-8. doi: 10.1542/peds.2007-2385.

  PMID: 18676546 BACKGROUND

• Williamson JA, Webb RK, Cockings J, Morgan C. The Australian Incident Monitoring Study. The capnograph: applications and limitations--an analysis of 2000 incident reports. Anaesth Intensive Care. 1993 Oct;21(5):551-7. doi: 10.1177/0310057X9302100510.

  PMID: 8273874 BACKGROUND

• Nassi N, Piumelli R, Lombardi E, Landini L, Donzelli G, de Martino M. Comparison between pulse oximetry and transthoracic impedance alarm traces during home monitoring. Arch Dis Child. 2008 Feb;93(2):126-32. doi: 10.1136/adc.2007.118513. Epub 2007 Sep 24.

  PMID: 17893118 BACKGROUND

• Kasuya Y, Akca O, Sessler DI, Ozaki M, Komatsu R. Accuracy of postoperative end-tidal Pco2 measurements with mainstream and sidestream capnography in non-obese patients and in obese patients with and without obstructive sleep apnea. Anesthesiology. 2009 Sep;111(3):609-15. doi: 10.1097/ALN.0b013e3181b060b6.

  PMID: 19672177 BACKGROUND

• Lerman J, Feldman D, Feldman R, Moser J, Feldman L, Sathyamoorthy M, Deitch K, Feldman U. Linshom respiratory monitoring device: a novel temperature-based respiratory monitor. Can J Anaesth. 2016 Oct;63(10):1154-1160. doi: 10.1007/s12630-016-0694-y. Epub 2016 Jul 13.

  PMID: 27412466 BACKGROUND

Related Links

• A thermodynamic breathing sensor - a new non-invasive monitor of respiration

Results Point of Contact

• Title: Dr. Madhankumar Sathyamoorthy, Principal Investigator
• Organization: University of Mississippi Medical Center

msathyamoorthy@umc.edu

6018157066

Study Officials

• Madhankumar Sathyamoorthy, MBBS, MS

  Children's of Mississippi/University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 12, 2017
• Study Start: September 8, 2017
• Primary Completion: September 8, 2017
• Study Completion: September 8, 2017
• Last Updated: July 5, 2018
• Results First Posted: July 5, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)