Noninvasive Ventilation Masks Carbon Dioxide Clearance in Normal Volunteers
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/27/2019 |
| Start Date: | March 30, 2018 |
| End Date: | August 30, 2019 |
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.
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. Demographic (age, gender, ethnicity) will be obtained.
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.
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. Demographic (age, gender, ethnicity) will be obtained.
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.
Inclusion Criteria:
- Healthy subjects greater than 18 years old.
Exclusion Criteria:
- Prior history of NIPPV as a patient.
- Facial surgery or deformity
- Ear infection
- History of pulmonary or cardiac disease
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