CapnographyFRSNCT03554629

A Comparison of Capnography Sampling Lines

A study testing Capnography CO2 cannula sampling Flexiterline (CCSF) designs with supplemental O2 in people with Capnography, run by Medtronic - MITG at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Capnography
What is being tested?: Capnography CO2 cannula sampling Flexiterline (CCSF) designs with supplemental O2
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 1 May 2018to 15 Sep 2020
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

Non-hospitalized adults ≥ 18 years old.
Willing and able to give informed consent.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinimark LLC
Louisville, Colorado, 80027

Other trials in United States

About this study

Read the 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.

Conditions: Capnography
Being tested: Capnography CO2 cannula sampling Flexiterline (CCSF) designs with supplemental O2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Capnography CO2 cannula sampling Flexiterline (CCSF) designs with supplemental O2Device
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.

Study groups in NCT03554629
Study group	Role	What they receive
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. Receives: Device: Capnography CO2 cannula sampling Flexiterline (CCSF) designs with supplemental O2

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Three hours

Secondary outcomes (2)

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.
Measured: 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.
Measured: Three hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 201815 Sep 2020

First posted13 Jun 2018
Study start1 May 2018
Primary completion31 Aug 2019
Study completion15 Sep 2020

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.
Other trials for CapnographyStudies 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03554629
Sponsor's protocol ID: MDT17063FRS
Acronym: FRS
Status last verified: Dec 2020
First submitted: 1 May 2018
Last updated: 6 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: De-identified individual participant data will not be shared

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
The Impact of Preoperative Nasal Capnography on Clinical Management in Patients Undergoing Diagnostic Bronchoscopy for Suspected Foreign Body Aspiration
Foreign Body Aspiration
Not yet recruiting
Evaluation of a Novel Portable Mainstream Capnograph MARIE in Adult Intubated Patients. A Prospective Validation Study
Intubation, Capnography
Not yet recruiting
Clinical Evaluation of an Alarm Activated Detection System to Enable Early Intervention of Emerging Respiratory Decline With the Linshom Medical Continuous Predictive Respiratory Sensor (CPRS)
Post Surgical Respiratory Failure, Respiratory Complication
Not yet recruiting
Transnasal Microstream EtCO2 Reduces Hypoxemia During Emergence in Aged Post-Abdomen Surgery
Elderly Patients, Laparoscopic Surgery
Not yet recruiting
Multifunctional Oropharyngeal Airway and Hypoxemia in Sedated GI Endoscopy: A Multicenter RCT
Hypoxemia, Airway Management

All Capnography trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of Capnography Sampling Lines
ClinicalTrials.gov ID: NCT03554629
Acronym / sponsor ID: FRS / MDT17063FRS
Conditions: Capnography
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Medtronic - MITGIndustry (pharma, biotech, devices)
Study start: 1 May 2018 (actual)
Primary completion: 31 Aug 2019 (actual)
Study completion: 15 Sep 2020 (actual)
First posted: 13 Jun 2018 (actual)
Results: Posted 16 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Capnography CO2 Sampling Filterline Performance	Other	Device: Capnography CO2 cannula sampling Flexiterline (CCSF) designs with supplemental O2Adult 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Non-hospitalized adults ≥ 18 years old.
Willing and able to give informed consent.

Key exclusion criteria (7 listed)

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.

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
Capnography CO2 cannula sampling Flexiterline (CCSF) designs with supplemental O2Use 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.	Device	Capnography CO2 Sampling Filterline Performance

Primary outcome

Capnography Measured CO2 Waveform Data as a Function of CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity
Time frame: 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.

2 secondary outcomes

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
Time frame: 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
Time frame: Three hours

Results and safety

Results posted to the registry on 16 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Eight Capnography CO2 Sampling Filterline Performance	29	23

Primary outcome: Capnography Measured CO2 Waveform Data as a Function of CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity

Time frame: Three hours. Mean (Standard Deviation). Unit: mmHg

Measure	EtCO2 During Mouth Closed Breathing Rate of 6 n = 23	FiCO2 During Mouth Closed Breathing Rate of 6 n = 23	EtCO2 During Mouth Closed Breathing Rate of 24 n = 23	FiCO2 During Mouth Closed Breathing Rate of 24 n = 23	EtCO2 During Mouth Open Breathing Rate of 6 n = 23	FiCO2 During Mouth Open Breathing Rate of 6 n = 23	EtCO2 Mouth Open Breathing Rate of 24 n = 23	FiCO2 Mouth Open Breathing Rate of 24 n = 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)

Population analysed: 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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FlexiCare (Nasal)	0 of 29 (0%)	2 of 29 (6.9%)	0 of 29
Hudson RCI /TeleFlex(Nasal)	0 of 29 (0%)	1 of 29 (3.4%)	0 of 29
Salter Lab (Nasal)	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Medtronic Filterline (Nasal)	0 of 29 (0%)	1 of 29 (3.4%)	0 of 29
WestMed (Oral/Nasal) RCI /TeleFlex(Nasal)	0 of 29 (0%)	2 of 29 (6.9%)	0 of 29
Dispo-Med (Oral/Nasal)	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Salter Lab Oral-Trac (Oral/Nasal)	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Medtronic Smart Capnoline+(Oral/Nasal)	0 of 29 (0%)	1 of 29 (3.4%)	0 of 29

Limitations and caveats (from the sponsor): 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 .

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. De-identified individual participant data will not be shared

Related trials for Capnography

Not yet recruitingObservational study
The Impact of Preoperative Nasal Capnography on Clinical Management in Patients Undergoing Diagnostic Bronchoscopy for Suspected Foreign Body Aspiration
Foreign Body Aspiration
Not yet recruiting
Evaluation of a Novel Portable Mainstream Capnograph MARIE in Adult Intubated Patients. A Prospective Validation Study
Intubation, Capnography
Not yet recruiting
Clinical Evaluation of an Alarm Activated Detection System to Enable Early Intervention of Emerging Respiratory Decline With the Linshom Medical Continuous Predictive Respiratory Sensor (CPRS)
Post Surgical Respiratory Failure, Respiratory Complication
Not yet recruiting
Transnasal Microstream EtCO2 Reduces Hypoxemia During Emergence in Aged Post-Abdomen Surgery
Elderly Patients, Laparoscopic Surgery
Not yet recruiting
Multifunctional Oropharyngeal Airway and Hypoxemia in Sedated GI Endoscopy: A Multicenter RCT
Hypoxemia, Airway Management

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.

Thomas A Miner, MD principal investigator

Clinimark, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Capnography CO2 cannula sampling Flexiterline (CCSF) designs with supplemental O2 in people with Capnography, run by Medtronic - MITG 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 2 inclusion and 7 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 6 Jan 2021. 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 16 Dec 2020). 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?

Capnography Measured CO2 Waveform Data as a Function of CO2 Cannula Sampling Filterline (CCSF) Stratified by Activity (time frame: Three hours). 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 NCT03554629.

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 6 Jan 2021.