Pulmonary VentilationNCT03279458
Non-invasive Tidal Volume Monitoring Using the Linshom Respiratory Monitoring Device
A study testing Linshom Respiratory Monitoring Device in people with Pulmonary Ventilation and Capnography, run by University of Mississippi Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Ventilation, Capnography
- What is being tested?
- Linshom Respiratory Monitoring Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2017to 8 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy
Who cannot join
- pregnant
- suffer from claustrophobia
- had recent respiratory illness
- had recent gastrointestinal illness
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Pulmonary Ventilation, Capnography
- Being tested
- Linshom Respiratory Monitoring Device
- Keywords
- Capnography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linshom Respiratory Monitoring DeviceDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Linshom Respiratory Monitoring Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start8 Sep 2017
- Primary completion8 Sep 2017
- Study completion8 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pulmonary VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhankumar Sathyamoorthy, University of Mississippi Medical Center
- Investigators
- Madhankumar Sathyamoorthy, MBBS, MS, Principal investigator, Children's of Mississippi/University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279458
- Sponsor's protocol ID
- 2017-0063
- Status last verified
- Jul 2018
- First submitted
- 6 Sep 2017
- Last updated
- 5 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share IPD
Publications
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.
PubMed 23871325Brouillette 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.
PubMed 3625404Ramsay 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.
PubMed 23632055Keidan 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.
PubMed 18676546Williamson 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.
PubMed 8273874Nassi 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.
PubMed 17893118Kasuya 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.
PubMed 19672177Lerman 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.
PubMed 27412466
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Tidal Volume Monitoring Using the Linshom Respiratory Monitoring Device
- ClinicalTrials.gov ID
- NCT03279458
- Acronym / sponsor ID
- 2017-0063
- Conditions
- Pulmonary Ventilation, Capnography
- Keywords
- Capnography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- 8 Sep 2017 (actual)
- Primary completion
- 8 Sep 2017 (actual)
- Study completion
- 8 Sep 2017 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Posted 5 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linshom Respiratory Monitoring Device | Experimental | Device: Linshom Respiratory Monitoring DeviceVolunteers 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. |
| Ventilator | Active comparator | Device: Linshom Respiratory Monitoring DeviceVolunteers 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy
Key exclusion criteria (5 listed)
- pregnant
- suffer from claustrophobia
- had recent respiratory illness
- had recent gastrointestinal illness
- unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linshom Respiratory Monitoring DeviceVolunteers 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. | Device | Linshom Respiratory Monitoring Device, Ventilator |
Primary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23871325Manifold 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.
- Background: PubMed 3625404Brouillette 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.
- Background: PubMed 23632055Ramsay 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.
- Background: PubMed 18676546Keidan 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.
- Background: PubMed 8273874Williamson 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.
- Background: PubMed 17893118Nassi 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.
- Background: PubMed 19672177Kasuya 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.
- Background: PubMed 27412466Lerman 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.
- A thermodynamic breathing sensor - a new non-invasive monitor of respirationLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhankumar Sathyamoorthy, MBBS, MS principal investigator
Children's of Mississippi/University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linshom Respiratory Monitoring Device in people with Pulmonary Ventilation and Capnography, run by University of Mississippi Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03279458, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.