Mask Leak With Nasal Cannula in Noninvasive Positive Pressure Ventilation



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2016
End Date:May 2016
Contact:Derek Brown, MD
Email:derek.j.brown1.mil@mail.mil
Phone:(210) 916 - 6129

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Analysis of Face Mask Leak With Nasal Cannula in Noninvasive Positive Pressure Ventilation: A Randomized Crossover Trial

This is a prospective randomized cross over study of healthy volunteers undergoing
continuous positive airway pressure ventilation via a noninvasive ventilation (NIV) mask
with and without the addition of nasal cannulas. Mask leak will be measured by the
ventilator after 60 seconds of spontaneous resting ventilation, with each subject serving as
his or her own control.

This is a randomized cross over study. A convenience sample of staff and resident physicians
and physician assistants from the San Antonio Military Medical Center (SAMMC) Department of
Emergency Medicine will be used to assess NIPPV mask seal during CPAP administration with
and without nasal cannula. Volunteers will be solicited via Grand Rounds and staff meetings
at San Antonio Military Medical Center. Subjects will undergo permuted block randomization
by random number generator to the order of intervention, mask alone or mask with nasal
cannula at 15L/min of oxygen. An emergency medicine trained physician will place equipment
and operate the ventilator. After placement of the NIPPV mask and prior to each study
intervention period, appropriate adjustments to enhance mask seal will be made as would
happen in a therapeutic setting and the volunteer will be allowed up to two minutes to
acclimate to continuous noninvasive positive pressure ventilation. Mask leak will be
measured by the ventilator unit and will be recorded after 60 seconds of spontaneous restful
ventilation.

Inclusion Criteria:

- 18 years of age

- Volunteer for study

Exclusion Criteria:

- Known cardiac disease

- Known pulmonary disease (to include respiratory infections)
We found this trial at
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San Antonio, Texas
Phone: 210-916-0808
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