FRS: A Comparison of Capnography Sampling Lines
Sponsor
Medtronic - MITG (Industry)
Overall Status
Completed
CT.gov ID
NCT03554629
Collaborator
(none)
30
1
1
28.5
1.1
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Comparison of Capnography Sampling Lines
Actual Study Start Date
:
May 1, 2018
Actual Primary Completion Date
:
Aug 31, 2019
Actual Study Completion Date
:
Sep 15, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Capnography CO2 Sampling Filterline Performance 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. |
Device: Capnography CO2 cannula sampling Flexiterline (CCSF) designs with supplemental O2
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.
|
Outcome Measures
Primary Outcome Measures
- Capnography Measured CO2 Waveform Data as a Function of CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity [Three hours]
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.
Secondary Outcome Measures
- 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 [Three hours]
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.
- 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 [Three hours]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Non-hospitalized adults ≥ 18 years old.
-
Willing and able to give informed consent.
Exclusion Criteria:
-
Lack of an informed consent.
-
Subjects not able to accommodate the proper application of the cannula.
-
Subject not willing or able to comply fully with the study procedures.
-
Subjects with sensitivity to nasal cannula in both nares.
-
Subject with skin allergies to medical adhesives.
-
Subjects with runny nose the day of the study participation.
-
Subject, who in the opinion of the Principal Investigator, should not be enrolled.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinimark LLC | Louisville | Colorado | United States | 80027 |
Sponsors and Collaborators
- Medtronic - MITG
Investigators
- Principal Investigator: Thomas A Miner, MD, Clinimark, LLC
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Medtronic - MITG
ClinicalTrials.gov Identifier:
NCT03554629
Other Study ID Numbers:
- MDT17063FRS
First Posted:
Jun 13, 2018
Last Update Posted:
Jan 6, 2021
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Study Results
Participant Flow
| Recruitment Details | 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) |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Eight Capnography CO2 Sampling Filterline Performance |
|---|---|
| Arm/Group Description | 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 |
| Period Title: Overall Study | |
| STARTED | 29 |
| COMPLETED | 23 |
| NOT COMPLETED | 6 |
Baseline Characteristics
| Arm/Group Title | Capnography CO2 Sampling Filterline |
|---|---|
| Arm/Group Description | Capnography CO2 Sampling Filterline: Use of up to 8 Capnography CO2 Sampling FIlterlines by blinded code name during scripted activities |
| Overall Participants | 23 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
18
78.3%
|
| >=65 years |
5
21.7%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
48.5
(17.1)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
14
60.9%
|
| Male |
9
39.1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
2
8.7%
|
| Not Hispanic or Latino |
21
91.3%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
1
4.3%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
3
13%
|
| White |
19
82.6%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (Count of Participants) | |
| United States |
23
100%
|
| Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [kg/m^2] |
27.5
(6.6)
|
Outcome Measures
| Title | Capnography Measured CO2 Waveform Data as a Function of CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity |
|---|---|
| Description | 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. |
| Time Frame | Three hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | EtCO2 During Mouth Closed Breathing Rate of 6 | FiCO2 During Mouth Closed Breathing Rate of 6 | EtCO2 During Mouth Closed Breathing Rate of 24 | FiCO2 During Mouth Closed Breathing Rate of 24 | EtCO2 During Mouth Open Breathing Rate of 6 | FiCO2 During Mouth Open Breathing Rate of 6 | EtCO2 Mouth Open Breathing Rate of 24 | FiCO2 Mouth Open Breathing Rate of 24 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patient interface to sample gas for EtCO2 capnography measurement under condition of closed mouth and respiration rate of 6 with supplemental O2 at 5lpm. | 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. | 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. | 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. | 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. | 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. | Patient interface to sample gas for capnography measurement under condition of open mouth breathing and respiration rate of 24 with supplemental O2 at 5lpm. | 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. |
| Measure Participants | 23 | 23 | 23 | 23 | 23 | 23 | 23 | 23 |
| FlexiCare (Nasal) |
30.6
(7.5)
|
0.0
(0.2)
|
26.6
(6.2)
|
0.2
(0.8)
|
20.1
(12.5)
|
0.1
(0.2)
|
19.1
(10.2)
|
0.2
(0.6)
|
| Hudson RCI /TeleFlex(Nasal) |
13.5
(8.4)
|
0.0
(0.0)
|
12.3
(6.9)
|
0.0
(0.1)
|
7.6
(6.6)
|
0.0
(0.0)
|
7.8
(7.2)
|
0.0
(0.0)
|
| Salter Lab (Nasal) |
30.1
(5.5)
|
0.4
(0.8)
|
24.1
(5.9)
|
1.4
(1.2)
|
22.3
(9.2)
|
0.2
(0.3)
|
19.9
(7.6)
|
1.0
(1.1)
|
| Medtronic Filterline (Nasal) |
32.6
(5.4)
|
0.0
(0.0)
|
28.1
(5.2)
|
0.0
(0.2)
|
24.8
(8.3)
|
0.0
(0.0)
|
22.7
(7.6)
|
0.0
(0.0)
|
| WestMed (Oral/Nasal) |
33.9
(4.8)
|
0.5
(0.4)
|
29.2
(5.8)
|
1.4
(1.5)
|
28.0
(8.9)
|
0.5
(0.6)
|
24.1
(8.1)
|
1.2
(1.4)
|
| Dispo-Med (Oral/Nasal) |
29.9
(7.5)
|
0.1
(0.3)
|
23.8
(8.2)
|
1.4
(0.9)
|
23.6
(6.9)
|
0.1
(0.2)
|
19.3
(7.0)
|
1.4
(1.3)
|
| Salter Lab Oral-Trac (Oral/Nasal) |
29.3
(8.7)
|
0.3
(0.5)
|
25.0
(6.9)
|
0.6
(0.9)
|
26.8
(5.2)
|
0.2
(0.3)
|
23.4
(4.7)
|
0.9
(1.1)
|
| Medtronic Smart Capnoline+(Oral/Nasal) |
32.6
(5.4)
|
0.0
(0.0)
|
28.8
(4.8)
|
0.0
(0.1)
|
26.8
(7.4)
|
0.0
(0.0)
|
24.9
(6.2)
|
0.0
(0.1)
|
| Title | 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 |
|---|---|
| Description | 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. |
| Time Frame | Three hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | 20 Second No Breath Alarm With Actual Respiration Rate of 24 | 30 Second No Breath Alarm With Actual Respiration Rate of 24 | 15 Second LOW RR 18 Alarm With Actual Respiration Rate of 24 | 30 Second LOW RR 18 With Actual Respiration Rate of 24 | 15 Second LOW RR 6 Alarm With Actual Respiration Rate of 24 | 30 Second LOW RR 6 With Actual Respiration Rate of 24 |
|---|---|---|---|---|---|---|
| Arm/Group Description | When actual respiration rate was 24 breaths per minute CO2 derived RR from the gas sample provide by the CO2 Cannula Sampling Filterline (CCSF) | When actual respiration rate was 24. CO2 derived RR from the gas sample provide by the CO2 Cannula Sampling Filterline (CCSF) | False Low RR for 15 - 29 seconds with patient interface gas sample for capnography derived respiration measurement under condition of subject respiration rate of 24 with supplemental O2 at 5lpm. | False Low RR for 15- 29 seconds with CCSF gas sample for capnography measurement. | False Low RR for 15 - 29 seconds with patient interface gas sample for capnography derived respiration measurement under condition of subject respiration rate of 24 with supplemental O2 at 5lpm. | False Low RR for 15 - 29 seconds with patient interface gas sample for capnography derived respiration measurement under condition of subject respiration rate of 24 with supplemental O2 at 5lpm. |
| Measure Participants | 23 | 23 | 23 | 23 | 23 | 23 |
| FlexiCare (Nasal) |
0.17
(0.53)
|
0.13
(0.40)
|
0.35
(0.57)
|
0.30
(0.51)
|
0.17
(0.38)
|
0.15
(0.36)
|
| Hudson/TeleFlex (Nasal) |
0.20
(0.40)
|
0.13
(0.34)
|
0.74
(0.53)
|
0.63
(0.57)
|
0.52
(0.51)
|
0.50
(0.51)
|
| Salter Labs (Nasal) |
0.02
(0.15)
|
0.02
(0.15)
|
0.37
(0.61)
|
0.22
(0.47)
|
0.13
(0.34)
|
0.04
(0.21)
|
| Medtronic CO2 (Nasal) |
0.02
(0.15)
|
0.02
(0.15)
|
0.17
(0.38)
|
0.11
(0.31)
|
0.13
(0.40)
|
0.07
(0.25)
|
| WestMed (Oral/Nasal) |
0.04
(0.29)
|
0.04
(0.29)
|
0.13
(0.34)
|
0.11
(0.31)
|
0.09
(0.28)
|
0.09
(0.28)
|
| DispoMed (Oral/Nasal) |
0.04
(0.21)
|
0.04
(0.21)
|
0.37
(0.53)
|
0.28
(0.46)
|
0.20
(0.45)
|
0.15
(0.36)
|
| Salter Oral-Trac (Oral/Nasal) |
0.02
(0.15)
|
0.02
(0.15)
|
0.22
(0.47)
|
0.11
(0.31)
|
0.13
(0.40)
|
0.07
(0.25)
|
| Medtronic Smart CapnoLine Plus (Oral/Nasal) |
0.00
(0.00)
|
0.00
(0.00)
|
0.09
(0.28)
|
0.09
(0.28)
|
0.04
(0.21)
|
0.04
(0.21)
|
| Title | 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 |
|---|---|
| Description | 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. |
| Time Frame | Three hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | 20 Second No Breath Alarm With Actual Respiration Rate of 6 | 30 Second No Breath Alarm With Actual Respiration Rate of 6 | 15 Second LOW RR 4 Alarm With Actual Respiration Rate of 6 | 30 Second LOW RR 4 With Actual Respiration Rate of 6 |
|---|---|---|---|---|
| Arm/Group Description | When actual respiration rate was 6 breaths per minute CO2 derived RR from the gas sample provide by the CO2 Cannula Sampling Filterline (CCSF) | When actual respiration rate was 6 . CO2 derived RR from the gas sample provide by the CO2 Cannula Sampling Filterline (CCSF) | False Low RR for 15 - 29 seconds with patient interface gas sample for capnography derived respiration measurement under condition of subject respiration rate of 24 with supplemental O2 at 5lpm. | False Low RR for 15- 29 seconds with CCSF gas sample for capnography measurement. |
| Measure Participants | 23 | 23 | 23 | 23 |
| FlexiCare (Nasal) |
0.13
(0.34)
|
0.09
(0.28)
|
0.24
(0.43)
|
0.22
(0.42)
|
| Hudson/TeleFlex (Nasal) |
0.30
(0.55)
|
0.24
(0.48)
|
0.54
(0.55)
|
0.43
(0.50)
|
| Salter Labs (Nasal) |
0.11
(0.31)
|
0.07
(0.25)
|
0.11
(0.31)
|
0.09
(0.28)
|
| Medtronic CO2 (Nasal) |
0.07
(0.25)
|
0.07
(0.25)
|
0.13
(0.34)
|
0.09
(0.28)
|
| WestMed (Oral/Nasal) |
0.02
(0.15)
|
0.02
(0.15)
|
0.07
(0.33)
|
0.04
(0.21)
|
| DispoMed (Oral/Nasal) |
0.04
(0.21)
|
0.02
(0.15)
|
0.11
(0.31)
|
0.07
(0.25)
|
| Salter Oral-Trac (Oral/Nasal) |
0.04
(0.21)
|
0.04
(0.21)
|
0.11
(0.31)
|
0.07
(0.25)
|
| Medtronic Smart CapnoLine Plus (Oral/Nasal) |
0.0
(0.0)
|
0.0
(0.0)
|
0.07
(0.25)
|
0.07
(0.25)
|
Adverse Events
| Time Frame | 3 hours | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Hypoxemia | |||||||||||||||
| Arm/Group Title | FlexiCare (Nasal) | Hudson RCI /TeleFlex(Nasal) | Salter Lab (Nasal) | Medtronic Filterline (Nasal) | WestMed (Oral/Nasal) RCI /TeleFlex(Nasal) | Dispo-Med (Oral/Nasal) | Salter Lab Oral-Trac (Oral/Nasal) | Medtronic Smart Capnoline+(Oral/Nasal) | ||||||||
| Arm/Group Description | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | ||||||||
All Cause Mortality |
||||||||||||||||
| FlexiCare (Nasal) | Hudson RCI /TeleFlex(Nasal) | Salter Lab (Nasal) | Medtronic Filterline (Nasal) | WestMed (Oral/Nasal) RCI /TeleFlex(Nasal) | Dispo-Med (Oral/Nasal) | Salter Lab Oral-Trac (Oral/Nasal) | Medtronic Smart Capnoline+(Oral/Nasal) | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) | ||||||||
Serious Adverse Events |
||||||||||||||||
| FlexiCare (Nasal) | Hudson RCI /TeleFlex(Nasal) | Salter Lab (Nasal) | Medtronic Filterline (Nasal) | WestMed (Oral/Nasal) RCI /TeleFlex(Nasal) | Dispo-Med (Oral/Nasal) | Salter Lab Oral-Trac (Oral/Nasal) | Medtronic Smart Capnoline+(Oral/Nasal) | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) | ||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| FlexiCare (Nasal) | Hudson RCI /TeleFlex(Nasal) | Salter Lab (Nasal) | Medtronic Filterline (Nasal) | WestMed (Oral/Nasal) RCI /TeleFlex(Nasal) | Dispo-Med (Oral/Nasal) | Salter Lab Oral-Trac (Oral/Nasal) | Medtronic Smart Capnoline+(Oral/Nasal) | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/29 (6.9%) | 1/29 (3.4%) | 0/29 (0%) | 1/29 (3.4%) | 2/29 (6.9%) | 0/29 (0%) | 0/29 (0%) | 1/29 (3.4%) | ||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Hypoxemia | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) | 1/29 (3.4%) | 1 | 0/29 (0%) | 1 | 0/29 (0%) | 1 | 0/29 (0%) | 1 | ||||
| Hypoxemia | 1/29 (3.4%) | 1 | 1/29 (3.4%) | 1 | 0/29 (0%) | 1 | 0/29 (0%) | 1 | 1/29 (3.4%) | 1 | 0/29 (0%) | 1 | 0/29 (0%) | 1 | 1/29 (3.4%) | 1 |
| Hypoxemia | 1/29 (3.4%) | 1 | 0/29 (0%) | 1 | 0/29 (0%) | 1 | 1/29 (3.4%) | 1 | 0/29 (0%) | 1 | 0/29 (0%) | 1 | 0/29 (0%) | 1 | 0/29 (0%) | 1 |
Limitations/Caveats
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 .
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Kathleen H. Niebel RN BSN BSME |
|---|---|
| Organization | Clinical Research Program Manager |
| Phone | 978-549-9325 |
| kathleen.h.niebel@gmail.com |
Responsible Party:
Medtronic - MITG
ClinicalTrials.gov Identifier:
NCT03554629
Other Study ID Numbers:
- MDT17063FRS
First Posted:
Jun 13, 2018
Last Update Posted:
Jan 6, 2021
Last Verified:
Dec 1, 2020