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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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Pulmonary Ventilation
Capnography
Intervention Device: Linshom Respiratory Monitoring Device
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Linshom Respiratory Monitoring Device
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 40
Completed [1] 40
Not Completed 0
[1]
The milestone was met if the participant was able to complete the breathing exercise.
Arm/Group Title Linshom
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
>= 18 years Number Analyzed 40 participants
40
 100.0%
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
Female
Male
[1]
Measure Analysis Population Description: The sex of participants was not collected.
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
Number of participants  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
40
 100.0%
1.Primary Outcome
Title Tidal Volume of Each Breath Was Measured Using the Same Breathing Mask CPAP Apparatus Combined With Respiratory Monitoring Device Allowing for Simultaneous Recording.
Hide Description 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)
Time Frame 5 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Linshom Maquet Ventilator
Hide Arm/Group Description:
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.
Tidal volume measured by the Maquet ventilator connected to CPAP mask concurrently with Linshom
Overall Number of Participants Analyzed 30 30
Least Squares Mean (95% Confidence Interval)
Unit of Measure: ml
0.94
(0.88 to 0.97)
0.94
(0.88 to 0.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Linshom, Maquet Ventilator
Comments [Not Specified]
Type of Statistical Test Other
Comments least square regression analysis
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter correlation coefficient (R)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.88 to 0.97
Estimation Comments [Not Specified]
Time Frame Adverse event data was collected for approximately 30 minutes, including the time while the patient was using the mask and the time immediately after completing the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Linshom Maquet Ventilator
Hide Arm/Group Description 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 maquet ventilatorconcurrently and the data downloaded in a Compact Flash card.
All-Cause Mortality
Linshom Maquet Ventilator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Linshom Maquet Ventilator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Linshom Maquet Ventilator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Madhankumar Sathyamoorthy, Principal Investigator
Organization: University of Mississippi Medical Center
Phone: 6018157066
Publications:
Responsible Party: Madhankumar Sathyamoorthy, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT03279458     History of Changes
Other Study ID Numbers: 2017-0063
First Submitted: September 6, 2017
First Posted: September 12, 2017
Results First Submitted: October 24, 2017
Results First Posted: July 4, 2018
Last Update Posted: July 4, 2018