CO2 ClearanceNCT03882723
Noninvasive Ventilation Masks Carbon Dioxide Clearance in Normal Volunteers
A study testing Evaluated 4 masks used for NIV with mechanical ventilators in people with CO2 Clearance and Mask Comfort, run by Rush University Medical Center at 1 site in United States.
Trial summary
This study will be a randomized crossover trial that will be conducted at Rush University. The study will be conducted with 20 healthy volunteers who will be placed on ICU ventilator operating in the NIPPV mode. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- CO2 Clearance, Mask Comfort, Rebreathing Exhaled Gas
- What is being tested?
- Evaluated 4 masks used for NIV with mechanical ventilators
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2018to 30 Aug 2019
- 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
- Healthy subjects greater than 18 years old.
Who cannot join
- Prior history of NIPPV as a patient.
- Facial surgery or deformity
- Ear infection
- History of pulmonary or cardiac disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Carbon Dioxide (CO2) Clearance From Various Face Masks in Normal Volunteers at Various Level of Expiratory Positive Airway Pressure (EPAP) When Using a Non-Invasive Positive Pressure Ventilation (NIPPV)
This study will be a randomized crossover trial that will be conducted at Rush University. The study will be conducted with 20 healthy volunteers who will be placed on ICU ventilator operating in the NIPPV mode. All subjects will perform 15 minutes of breathing on NIPPV on each mask of the 4 different masks (2 oronasal and 2 full face masks) that are randomly selected. Breathing through each mask will be followed by a 5- minute wash out period between masks. End tidal Carbon Dioxide (EtCO2) will be sampled nasal/oral. Different levels of EPAP will be set and CO2 clearance will be monitored. Additionally, subjective mask comfort will be assessed via visual analog scale (VAS) with 1 referring to least comfortable and 5 being the most comfortable.
Read the detailed description
This study will be a randomized crossover trial that will be conducted at Rush University. Normal volunteers will be recruited from Rush University Medical Centers. Volunteers will be screened with inclusion and exclusion criteria and an informed consent is required in order for them to participate.
Also, initial baseline vital signs (heart rate, blood pressure, respiratory rate, and oxygen saturation) will be obtained. EtCO2 will be obtained at baseline and periodically using an oral/nasal sample line with the CapnostreamTM 20p monitor (Medtronic, Minneapolis, MN). The study will use a double limb circuit ICU ventilator Puritan Bennett™ (Medtronic, Dublin, Ireland).
Investigators will evaluate 4 NIPPV masks (2 oronasal masks and 2 full face masks). Oronasal masks will be labeled as group A and numbered as A1 and A2; while full face masks will be labeled group B and numbered as B1 and B2. Order of the masks will be randomly chosen in two steps. First steps will be choosing A or B then randomly assign mask in each of these groups. Investigators will randomly assign mask in group A or B by drawing an initial mask from the group and then continue the sequence of masks from that point. For example, investigators randomly chose group A, then randomly chose A2, the sequence will be A2, A1. Then Investigators would randomly choose B2, then the sequence would be B2, B1. All subjects will perform 15 minutes on each mask followed by 5 minutes wash out interval between masks. EPAP levels will be 0, 2, 4, \& 5 while IPAP remains at 5 higher than EPAP. EtCO2 will be collected at 4:00, 4:30 and 5:00 minute mark. These three measures should differ by less than 20% of their average. Also, subjective mask ORA: 18011502-IRB01 Date IRB Approved: 3/30/2018 Amendment Date: 5/11/2018 comfort will be assessed via visual analog scale (VAS) with 1 referring to least comfortable and 5 being the most comfortable after 5 each EPAP setting.
- Conditions
- CO2 Clearance, Mask Comfort, Rebreathing Exhaled Gas
- Being tested
- Evaluated 4 masks used for NIV with mechanical ventilators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluated 4 masks used for NIV with mechanical ventilatorsDevice
Order of the masks (BiTrac MaxShield™ with standard elbow, BiTrac™ Full Face with standard elbow, Respironics PerforMax with standard elbow, and Respironics AF531 with standard elbow) were randomly chosen. Investigators randomly assigned all masks for paper raffling from container. All subjects performed 20 minutes on each mask followed by 5 minutes wash out interval between masks. EPAP levels will be 0, 2, 4, \& 5 (5 minutes for each level) while IPAP remains at 5 higher than EPAP. FiCO2 and EtCO2 were collected at 4:00, 4:30 and 5:00 minute mark for each EPAP level. Also, subjective mask comfort was assessed via visual analog scale (VAS) with 1 referring to least comfortable and 5 being the most comfortable after 5 each EPAP setting.
| Study group | Role | What they receive |
|---|---|---|
| Randomized Crossover Trial with 4 NIV Masks | Experimental | Order of the masks (BiTrac MaxShield™ with standard elbow, BiTrac™ Full Face with standard elbow, Respironics PerforMax with standard elbow, and Respironics AF531 with standard elbow) were randomly chosen. Investigators randomly assigned all masks for paper raffling from container. All subjects performed 20 minutes on each mask followed by 5 minutes wash out between masks. EPAP levels will be 0, 2, 4, \& 5 (5 minutes for each level) while IPAP remains at 5 higher than EPAP. FiCO2 and EtCO2 were collected at 4:00, 4:30 and 5:00 minute mark for each EPAP level. Also, subjective mask comfort was assessed via visual analog scale (VAS) with 1 referring to least comfortable and 5 being the most comfortable after 5 each EPAP setting. Receives: Device: Evaluated 4 masks used for NIV with mechanical ventilators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbon Dioxide Clearance From the Masks
Measured the percentage of CO2 being re-breathed or inspired using a nasal cannula and sidestream end-tidal CO2 monitor.
Measured: 5 min
Secondary outcomes (3)
Leak (L/Min)
Amount of leak measured by the ventilator.
Measured: 5 min
Tidal Volume
Tidal volume measured by the ventilator.
Measured: 5 minutes
Respiratory Rate (BPM)
The ventilator measured the subjects' respiratory rates.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start30 Mar 2018
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
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 CO2 ClearanceStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- randomized crossover trial
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Vines, PhD, Study chair, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882723
- Sponsor's protocol ID
- ORA: 18011502-IRB01
- Status last verified
- Jun 2023
- First submitted
- 18 Mar 2019
- Last updated
- 28 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbon Dioxide (CO2) Clearance From Various Face Masks in Normal Volunteers at Various Level of Expiratory Positive Airway Pressure (EPAP) When Using a Non-Invasive Positive Pressure Ventilation (NIPPV)
- ClinicalTrials.gov ID
- NCT03882723
- Acronym / sponsor ID
- ORA: 18011502-IRB01
- Conditions
- CO2 Clearance, Mask Comfort, Rebreathing Exhaled Gas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Posted 28 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be a randomized crossover trial that will be conducted at Rush University. The study will be conducted with 20 healthy volunteers who will be placed on ICU ventilator operating in the NIPPV mode. All subjects will perform 15 minutes of breathing on NIPPV on each mask of the 4 different masks (2 oronasal and 2 full face masks) that are randomly selected. Breathing through each mask will be followed by a 5- minute wash out period between masks. End tidal Carbon Dioxide (EtCO2) will be sampled nasal/oral. Different levels of EPAP will be set and CO2 clearance will be monitored. Additionally, subjective mask comfort will be assessed via visual analog scale (VAS) with 1 referring to least comfortable and 5 being the most comfortable.
Detailed description
This study will be a randomized crossover trial that will be conducted at Rush University. Normal volunteers will be recruited from Rush University Medical Centers. Volunteers will be screened with inclusion and exclusion criteria and an informed consent is required in order for them to participate.
Also, initial baseline vital signs (heart rate, blood pressure, respiratory rate, and oxygen saturation) will be obtained. EtCO2 will be obtained at baseline and periodically using an oral/nasal sample line with the CapnostreamTM 20p monitor (Medtronic, Minneapolis, MN). The study will use a double limb circuit ICU ventilator Puritan Bennett™ (Medtronic, Dublin, Ireland).
Investigators will evaluate 4 NIPPV masks (2 oronasal masks and 2 full face masks). Oronasal masks will be labeled as group A and numbered as A1 and A2; while full face masks will be labeled group B and numbered as B1 and B2. Order of the masks will be randomly chosen in two steps. First steps will be choosing A or B then randomly assign mask in each of these groups. Investigators will randomly assign mask in group A or B by drawing an initial mask from the group and then continue the sequence of masks from that point. For example, investigators randomly chose group A, then randomly chose A2, the sequence will be A2, A1. Then Investigators would randomly choose B2, then the sequence would be B2, B1. All subjects will perform 15 minutes on each mask followed by 5 minutes wash out interval between masks. EPAP levels will be 0, 2, 4, \& 5 while IPAP remains at 5 higher than EPAP. EtCO2 will be collected at 4:00, 4:30 and 5:00 minute mark. These three measures should differ by less than 20% of their average. Also, subjective mask ORA: 18011502-IRB01 Date IRB Approved: 3/30/2018 Amendment Date: 5/11/2018 comfort will be assessed via visual analog scale (VAS) with 1 referring to least comfortable and 5 being the most comfortable after 5 each EPAP setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- randomized crossover trial
| Arm | Type | Receives |
|---|---|---|
| Randomized Crossover Trial with 4 NIV Masks | Experimental | Device: Evaluated 4 masks used for NIV with mechanical ventilatorsOrder of the masks (BiTrac MaxShield™ with standard elbow, BiTrac™ Full Face with standard elbow, Respironics PerforMax with standard elbow, and Respironics AF531 with standard elbow) were randomly chosen. Investigators randomly assigned all masks for paper raffling from container. All subjects performed 20 minutes on each mask followed by 5 minutes wash out between masks. EPAP levels will be 0, 2, 4, \& 5 (5 minutes for each level) while IPAP remains at 5 higher than EPAP. FiCO2 and EtCO2 were collected at 4:00, 4:30 and 5:00 minute mark for each EPAP level. Also, subjective mask comfort was assessed via visual analog scale (VAS) with 1 referring to least comfortable and 5 being the most comfortable after 5 each EPAP setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects greater than 18 years old.
Key exclusion criteria (4 listed)
- Prior history of NIPPV as a patient.
- Facial surgery or deformity
- Ear infection
- History of pulmonary or cardiac disease
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 |
|---|---|---|
| Evaluated 4 masks used for NIV with mechanical ventilatorsOrder of the masks (BiTrac MaxShield™ with standard elbow, BiTrac™ Full Face with standard elbow, Respironics PerforMax with standard elbow, and Respironics AF531 with standard elbow) were randomly chosen. Investigators randomly assigned all masks for paper raffling from container. All subjects performed 20 minutes on each mask followed by 5 minutes wash out interval between masks. EPAP levels will be 0, 2, 4, \& 5 (5 minutes for each level) while IPAP remains at 5 higher than EPAP. FiCO2 and EtCO2 were collected at 4:00, 4:30 and 5:00 minute mark for each EPAP level. Also, subjective mask comfort was assessed via visual analog scale (VAS) with 1 referring to least comfortable and 5 being the most comfortable after 5 each EPAP setting. | Device | Randomized Crossover Trial with 4 NIV Masks |
Primary outcome
Carbon Dioxide Clearance From the Masks
Time frame: 5 min
Measured the percentage of CO2 being re-breathed or inspired using a nasal cannula and sidestream end-tidal CO2 monitor.
3 secondary outcomes
Leak (L/Min)
Time frame: 5 min
Tidal Volume
Time frame: 5 minutes
Respiratory Rate (BPM)
Time frame: 5 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for CO2 Clearance
Recruiting
Liquid Nitrogen Cryotherapy Versus CO₂ Laser for Palmoplantar Warts
Palmoplantar Warts
Recruiting
Carbon Dioxide Administration and Brain Waste Clearance
Traumatic Brain Injury, Aging Disorder
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.
David Vines, PhD study chair
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluated 4 masks used for NIV with mechanical ventilators in people with CO2 Clearance and Mask Comfort, run by Rush University Medical Center 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 1 inclusion and 4 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 28 Jun 2023. 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 28 Jun 2023). 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?
Carbon Dioxide Clearance From the Masks (time frame: 5 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2023.