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This study evaluates the performance of eight (8) cleared capnography carbon dioxide (CO2) sampling filterlines during patient simulated scripted activities when connected to a Medtronic (MDT) dual parameter monitor.
The eight (8) Capnography CO2 Sampling Filterlines (CCSF) have different designs for obtaining a gas sample for CO2 measurement and also for delivering supplemental oxygen (O2).
In this study awake, healthy volunteers will evaluate the 8 CCSF (Capnography CO2 Sampling Filterline) to determine their performance variability in providing a representative exhaled CO2 sample for measurement on the Capnostream 35 dual parameter monitor during scripted activities of closed mouth/open mouth breathing during both high and low respiration rate with supplemental oxygen delivery at 5lpm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capnography CO2 Sampling Filterline Performance | Other | Adult volunteer exhaled gas was sampled by 8 different CO2 cannula sampling filterline (CCSF) designs connected to a Capnostream 35 for measurement of CO2 during patient simulated scripted activities in order to assess patient interface design performance to provide a quality gas sample for CO2 partial pressure measurement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capnography CO2 cannula sampling Flexiterline (CCSF) designs with supplemental O2 | Device | Use of 8 post-market nasal CO2 cannula sampling filterlines; 4 nasal only sampling ports manufactured by Medtronic, Salter, Hudson/Teleflex and FlexiCare) and 4 post-market oral/nasal sampling ports manufactured by Medtronic, Salter, Dispo-Med and Westmed during scripted activity with supplemental O2. |
| Measure | Description | Time Frame |
|---|---|---|
| Capnography Measured CO2 Waveform Data as a Function of CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity | Comparison of measured end-tidal CO2 (EtCO2), Rebreathing as measured by fractional inspiratory CO2 (FiCO2) as a function the activity for 8 different CCSF designs tested on 23 subjects with supplemental O2 at 5lmp for four activities. Device data collected a 20Hz (20 data points/second) for the 3 hours of enrollment. Participants lateral lying with head on a pillow with supplemental O2 during each nasal only or open mouth breathing at respiration rate of 6 and 24. | Three hours |
| Measure | Description | Time Frame |
|---|---|---|
| Average Number of Alarms as a Function of Each Capnography CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity With an Actual Respiration Rate of 24 | Gas sample provided by CCSF to the Capnostream 35 for measurement of the partial pressure of CO2 as a function of time. The Capnostream 35 Respiration rate algorithm counts the breaths per minute based upon the frequency of a CO2 validated breath waveform. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas A Miner, MD | Clinimark, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinimark LLC | Louisville | Colorado | 80027 | United States |
De-identified individual participant data will not be shared
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Execution of CIP v 1 enrollment at 6; data not included in results since data inadequate.
Execution of CIP V2 enrollment was 23 One subject withdrawn before participation due to failure to meet failure to meet criteria of enrollment on the study day (runny nose)
| ID | Title | Description |
|---|---|---|
| FG000 | Eight Capnography CO2 Sampling Filterline Performance | Capnography CO2 Sampling FIlterlines blinded by code name during scripted activities for data analysis. All subjects worn all 8 CCSF devices under test for the four study activities. 1 and 2. Closed mouth breathing with respiration rate of 6 and 24 3 and 4. Open mouth breathing with respiration rate at 6 and 24 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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One subject withdrawn before study participation Data on 6 subjects removed due to insufficient data
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| ID | Title | Description |
|---|---|---|
| BG000 | Capnography CO2 Sampling Filterline | Capnography CO2 Sampling Filterline: Use of up to 8 Capnography CO2 Sampling FIlterlines by blinded code name during scripted activities |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Capnography Measured CO2 Waveform Data as a Function of CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity | Comparison of measured end-tidal CO2 (EtCO2), Rebreathing as measured by fractional inspiratory CO2 (FiCO2) as a function the activity for 8 different CCSF designs tested on 23 subjects with supplemental O2 at 5lmp for four activities. Device data collected a 20Hz (20 data points/second) for the 3 hours of enrollment. Participants lateral lying with head on a pillow with supplemental O2 during each nasal only or open mouth breathing at respiration rate of 6 and 24. | Performance of 8 CO2 cannula sampling filterlines (CCSF): 4 filterlines provided nasal only sampling ports and 4 filterlines provided both nasal and oral sampling ports. Each of the 8 CCSF was assigned a letter by the investigation site to maintain blinding in data analysis. Side-stream capnography measurement via the Capnostream 35 | Posted | Mean | Standard Deviation | mmHg | Three hours |
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3 hours
Hypoxemia
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FlexiCare (Nasal) | 8 Capnography CO2 Sampling FIlterlines blinded by code name during scripted activities with supplemental oxygen at 5lpm for each participant. Adverse event Conditions that required a stop of the procedures until SpO2 > 90% were the following |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoxemia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment | Low Oxygenation with SpO2 < 90% via finger pulse Oximeter Supplemental O2 at 5lpm Occurred with Open Mouth Breathing at RR = 6 |
Strategy to test four simulated patient activities that would most likely effect a quality gas sample for measurement of CO2 partial pressure was selected to maintain active enrollment to three hours .
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen H. Niebel RN BSN BSME | Clinical Research Program Manager | 978-549-9325 | kathleen.h.niebel@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 28, 2018 | Aug 20, 2020 | SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 1, 2018 | Sep 29, 2020 | Prot_002.pdf |
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| Three hours |
| Average Number of Alarms as a Function of Each Capnography CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity With an Actual Respiration Rate of 6 | Gas sample provided by CCSF to the Capnostream 35 for measurement of the partial pressure of CO2 as a function of time. The Capnostream 35 Respiration rate algorithm counts the breaths per minute based upon the frequency of a CO2 validated breath waveform. | Three hours |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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Patient interface to sample gas for EtCO2 capnography measurement under condition of closed mouth and respiration rate of 6 with supplemental O2 at 5lpm. |
| OG001 | FiCO2 During Mouth Closed Breathing Rate of 6 | Patient interface to remove stale air when providing a gas sample for capnography measurement of Fractional Inspired CO2 (re-breathing) under condition of closed mouth and respiration rate of 6 with supplemental O2 at 5lpm. |
| OG002 | EtCO2 During Mouth Closed Breathing Rate of 24 | Patient interface to sample gas for end tidal CO2 (EtCO2)capnography measurement under condition of closed mouth and respiration rate of 24 with supplemental O2 at 5lpm. |
| OG003 | FiCO2 During Mouth Closed Breathing Rate of 24 | Patient interface to remove stale air when providing a gas sample for capnography measurement of Fractional Inspired CO2 (re-breathing) under condition of closed mouth and respiration rate of 24 with supplemental O2 at 5lpm. |
| OG004 | EtCO2 During Mouth Open Breathing Rate of 6 | Patient interface to sample gas for end tidal CO2 (EtCO2) capnography measurement under condition of open mouth breathing and respiration rate of 6 with supplemental O2 at 5lpm. |
| OG005 | FiCO2 During Mouth Open Breathing Rate of 6 | Patient interface to remove stale air when providing a gas sample for capnography measurement of Fractional Inspired CO2 (re-breathing) under condition of open mouth breathing and respiration rate of 6 with supplemental O2 at 5lpm. |
| OG006 | EtCO2 Mouth Open Breathing Rate of 24 | Patient interface to sample gas for capnography measurement under condition of open mouth breathing and respiration rate of 24 with supplemental O2 at 5lpm. |
| OG007 | FiCO2 Mouth Open Breathing Rate of 24 | Patient interface to remove stale air when providing a gas sample for capnography measurement of Fractional Inspired CO2 (re-breathing) under condition of open mouth breathing and respiration rate of 24 with supplemental O2 at 5lpm. |
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| Secondary | Average Number of Alarms as a Function of Each Capnography CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity With an Actual Respiration Rate of 24 | Gas sample provided by CCSF to the Capnostream 35 for measurement of the partial pressure of CO2 as a function of time. The Capnostream 35 Respiration rate algorithm counts the breaths per minute based upon the frequency of a CO2 validated breath waveform. | Participant actual Respiration Rate was coached using the Pace Breathing Android App: Version 2.1. RR = 6 : Inspiratory Time was 5.0 seconds and Expiratory time was 5.0 seconds No breath alarm is deployed when both RR and EtCO2 are equal to zero. RR = 24: Inspiratory Time was 1.2 seconds and Expiratory time was 1.3 seconds | Posted | Mean | Standard Deviation | Alarms | Three hours |
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| Secondary | Average Number of Alarms as a Function of Each Capnography CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity With an Actual Respiration Rate of 6 | Gas sample provided by CCSF to the Capnostream 35 for measurement of the partial pressure of CO2 as a function of time. The Capnostream 35 Respiration rate algorithm counts the breaths per minute based upon the frequency of a CO2 validated breath waveform. | Participant actual Respiration Rate was coached using the Pace Breathing Android App: Version 2.1. RR = 6 : Inspiratory Time was 5.0 seconds and Expiratory time was 5.0 seconds No breath alarm is deployed when both RR and EtCO2 are equal to zero. RR = 24: Inspiratory Time was 1.2 seconds and Expiratory time was 1.3 seconds | Posted | Mean | Standard Deviation | Alarms | Three hours |
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| 0 |
| 29 |
| 0 |
| 29 |
| 2 |
| 29 |
| EG001 | Hudson RCI /TeleFlex(Nasal) | 8 Capnography CO2 Sampling FIlterlines blinded by code name during scripted activities with supplemental oxygen at 5lpm for each participant. Adverse event Conditions that required a stop of the procedures until SpO2 > 90% were the following | 0 | 29 | 0 | 29 | 1 | 29 |
| EG002 | Salter Lab (Nasal) | 8 Capnography CO2 Sampling FIlterlines blinded by code name during scripted activities with supplemental oxygen at 5lpm for each participant. Adverse event Conditions that required a stop of the procedures until SpO2 > 90% were the following | 0 | 29 | 0 | 29 | 0 | 29 |
| EG003 | Medtronic Filterline (Nasal) | 8 Capnography CO2 Sampling FIlterlines blinded by code name during scripted activities with supplemental oxygen at 5lpm for each participant. Adverse event Conditions that required a stop of the procedures until SpO2 > 90% were the following | 0 | 29 | 0 | 29 | 1 | 29 |
| EG004 | WestMed (Oral/Nasal) RCI /TeleFlex(Nasal) | 8 Capnography CO2 Sampling FIlterlines blinded by code name during scripted activities with supplemental oxygen at 5lpm for each participant. Adverse event Conditions that required a stop of the procedures until SpO2 > 90% were the following | 0 | 29 | 0 | 29 | 2 | 29 |
| EG005 | Dispo-Med (Oral/Nasal) | 8 Capnography CO2 Sampling FIlterlines blinded by code name during scripted activities with supplemental oxygen at 5lpm for each participant. Adverse event Conditions that required a stop of the procedures until SpO2 > 90% were the following | 0 | 29 | 0 | 29 | 0 | 29 |
| EG006 | Salter Lab Oral-Trac (Oral/Nasal) | 8 Capnography CO2 Sampling FIlterlines blinded by code name during scripted activities with supplemental oxygen at 5lpm for each participant. Adverse event Conditions that required a stop of the procedures until SpO2 > 90% were the following | 0 | 29 | 0 | 29 | 0 | 29 |
| EG007 | Medtronic Smart Capnoline+(Oral/Nasal) | 8 Capnography CO2 Sampling FIlterlines blinded by code name during scripted activities with supplemental oxygen at 5lpm for each participant. Adverse event Conditions that required a stop of the procedures until SpO2 > 90% were the following | 0 | 29 | 0 | 29 | 1 | 29 |
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| Hypoxemia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment | Low Oxygenation with SpO2 < 90% via finger pulse Oximeter Supplemental O2 at 5lpm Occurred with Open Mouth Breathing at RR = 24 |
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| Hypoxemia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment | Low Oxygenation with SpO2 < 90% via finger pulse Oximeter Supplemental O2 at 5lpm Occurred with Closed Mouth Breathing at RR = 6 |
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| Hudson/TeleFlex (Nasal) |
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| Salter Labs (Nasal) |
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| Medtronic CO2 (Nasal) |
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| WestMed (Oral/Nasal) |
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| DispoMed (Oral/Nasal) |
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| Salter Oral-Trac (Oral/Nasal) |
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| Medtronic Smart CapnoLine Plus (Oral/Nasal) |
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| Hudson/TeleFlex (Nasal) |
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| Salter Labs (Nasal) |
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| Medtronic CO2 (Nasal) |
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| WestMed (Oral/Nasal) |
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| DispoMed (Oral/Nasal) |
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| Salter Oral-Trac (Oral/Nasal) |
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| Medtronic Smart CapnoLine Plus (Oral/Nasal) |
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