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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluated 4 masks used for NIV with mechanical ventilators | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 min |
| Measure | Description | Time Frame |
|---|---|---|
| Leak (L/Min) | Amount of leak measured by the ventilator. | 5 min |
| Tidal Volume | Tidal volume measured by the ventilator. | 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Vines, PhD | Rush University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
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This was a randomized crossover trial so each participate used all four masks (BiTrac MaxShield™ with standard elbow, BiTrac™ Full Face with standard elbow, Respironics PerforMax with standard elbow, and Respironics AF531 with standard elbow).
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| ID | Title | Description |
|---|---|---|
| FG000 | Randomized Crossover Trial With 4 NIV Masks | Order of the 4 masks (BiTrac MaxShield™ with standard elbow, BiTrac™ Full Face with standard elbow, Respironics PerforMax with standard elbow, and Respironics PerforMax 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. Evaluated masks used for NIV with mechanical ventilators: Order of the masks 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomized Crossover Trial With 4 NIV Masks | Order of the masks (BiTrac MaxShield™ with standard elbow, BiTrac™ Full Face with standard elbow, Respironics PerforMax with standard elbow, and Respironics PerforMax 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. Evaluated masks used for NIV with mechanical ventilators: Order of the masks 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Greater than 18 years of age |
| 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 | 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. | The study protocol and statistical analysis planned to have this outcome measure be analyzed and reported per PEEP level, not per intervention. There were 8 participants and 4 masks, making 32 unique measures for each PEEP level. This pilot project aimed to identify that CO2 rebreathing existed when using a dual limb circuit. Individual mask data may misrepresent the issue and be inappropriately used for marketing purposes. | Posted | Median | Inter-Quartile Range | percentage of CO2 inspired | 5 min |
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Adverse events were collected during data collection which was approximately 1.5 hours.
The study would be stopped if subjects' HR changed by 20% from baseline for more than 1 min and/or complained of shortness of breath.
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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 | Randomized Crossover Trial With 4 NIV Masks | Order of the 4 masks were randomly chosen. Investigators randomly assigned all masks for paper raffling from a 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. The study protocol and statistical analysis planned to have all outcome measures and adverse events be analyzed and reported per PEEP level, not per intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Vines | Rush University Medical Center | 3129424408 | David_Vines@rush.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 11, 2018 | Oct 27, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 15, 2019 | Oct 27, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| D012122 | Ventilators, Mechanical |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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randomized crossover trial
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|
| Respiratory Rate (BPM) | The ventilator measured the subjects' respiratory rates. | 5 minutes |
| Count of Participants |
| Participants |
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| Sex/Gender, Customized | This data was not collected. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| No history of pulmonary or cardiac disease | Participants asked if they had a history of pulmonary or cardiac disease. | Count of Participants | Participants |
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| No current ear infection | Participants were asked if they had an ear infection. | Count of Participants | Participants |
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| No history of use of noninvasive ventilation | Participants were asked if they had used noninvasive ventilation before. | Count of Participants | Participants |
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| no facial surgery or deformity that would interfere with the mask seal. | participants were observed for face deformities or surgery that would interfere with the mask seal. | Count of Participants | Participants |
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A PEEP of 2 cmH2O was applied to the masks. |
| OG002 | PEEP 4 | A PEEP of 4 cmH2O was applied to the masks. |
| OG003 | PEEP 5 | A PEEP of 5 cmH2O was applied to the masks. |
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| Secondary | Leak (L/Min) | Amount of leak measured by the ventilator. | The study protocol and statistical analysis planned to have this outcome measure be analyzed and reported per PEEP level, not per intervention. There were 8 participants and 4 masks, making 32 unique measures for each PEEP level. This pilot project aimed to identify that CO2 rebreathing existed when using a dual limb circuit. Individual mask data may misrepresent the issue and be inappropriately used for marketing purposes. | Posted | Median | Inter-Quartile Range | Liters per minute | 5 min |
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| Secondary | Tidal Volume | Tidal volume measured by the ventilator. | The study protocol and statistical analysis planned to have this outcome measure be analyzed and reported per PEEP level, not per intervention. There were 8 participants and 4 masks, making 32 unique measures for each PEEP level. This pilot project aimed to identify that CO2 rebreathing existed when using a dual limb circuit. Individual mask data may misrepresent the issue and be inappropriately used for marketing purposes. | Posted | Mean | Inter-Quartile Range | milliliters | 5 minutes |
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| Secondary | Respiratory Rate (BPM) | The ventilator measured the subjects' respiratory rates. | The study protocol and statistical analysis planned to have this outcome measure be analyzed and reported per PEEP level, not per intervention. There were 8 participants and 4 masks, making 32 unique measures for each PEEP level. This pilot project aimed to identify that CO2 rebreathing existed when using a dual limb circuit. Individual mask data may misrepresent the issue and be inappropriately used for marketing purposes. | Posted | Median | Inter-Quartile Range | breaths per minute | 5 minutes |
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| 0 |
| 8 |
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| 8 |
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| 8 |
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| D004864 |
| Equipment and Supplies |