N/A N=8 Treatment

Noninvasive Ventilation Masks Carbon Dioxide Clearance in Normal Volunteers

CO2 Clearance · Mask Comfort · Rebreathing Exhaled Gas

Bottom Line

View on ClinicalTrials.gov: NCT03882723 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2023

Primary outcome: Primary: Carbon Dioxide Clearance From the Masks — 1.83; 1; 0.49; 0 percentage of CO2 inspired

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Evaluated 4 masks used for NIV with mechanical ventilators (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Rush University Medical Center
Primary completion: Aug 2019

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	—

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.

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

View full record on ClinicalTrials.gov →

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.