Trial Outcomes & Findings for Non-invasive Tidal Volume Monitoring Using the Linshom Respiratory Monitoring Device (NCT NCT03279458)
NCT ID: NCT03279458
Last Updated: 2018-07-05
Results Overview
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)
COMPLETED
NA
40 participants
5 minutes
2018-07-05
Participant Flow
Participant milestones
| Measure |
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. The tidal volume will also be measured by the ventilator and the data downloaded in a Compact Flash card.
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|---|---|
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Overall Study
STARTED
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40
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Overall Study
COMPLETED
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40
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Linshom
n=40 Participants
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.
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|---|---|
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Age, Customized
>= 18 years
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40 Participants
n=40 Participants
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Region of Enrollment
United States
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40 participants
n=40 Participants
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Number of participants
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40 Participants
n=40 Participants
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PRIMARY outcome
Timeframe: 5 minutesPopulation: Thirty participants successfully completed the experiment, which involved breathing through a CPAP mask in order to have the Linshom device record excursions of the thermistor tracings while the ventilator concurrently measured tidal volume.
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)
Outcome measures
| Measure |
Linshom
n=30 Participants
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.
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Maquet Ventilator
n=30 Participants
Tidal volume measured by the Maquet ventilator connected to CPAP mask concurrently with Linshom
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|---|---|---|
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Tidal Volume of Each Breath Was Measured Using the Same Breathing Mask CPAP Apparatus Combined With Respiratory Monitoring Device Allowing for Simultaneous Recording.
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0.94 ml
Interval 0.88 to 0.97
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0.94 ml
Interval 0.88 to 0.97
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Adverse Events
Linshom
Maquet Ventilator
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Madhankumar Sathyamoorthy, Principal Investigator
University of Mississippi Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place