N/A
Completed N=8
Noninvasive Ventilation Masks Carbon Dioxide Clearance in Normal Volunteers
CO2 Clearance · Mask Comfort · Rebreathing Exhaled Gas
Source: ClinicalTrials.gov NCT03882723 ↗
Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: Carbon Dioxide Clearance From the Masks — 1.83; 1; 0.49; 0 percentage of CO2 inspired
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. 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Carbon Dioxide Clearance From the Masks |
1.83; 1; 0.49; 0 | — |
| SECONDARY Leak (L/Min) |
22; 30; 36; 41 | — |
| SECONDARY Tidal Volume |
636; 646; 637; 701 | — |
| SECONDARY Respiratory Rate (BPM) |
13; 15; 15; 15 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03882723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.