Mask Leak With Nasal Cannula in Noninvasive Positive Pressure Ventilation

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Mechanical Ventilation Pressure High

Intervention / Treatment
-----------------
* Device: Nasal cannula
* Device: Non-invasive positive pressure ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age Volunteer for study Exclusion Criteria: Known cardiac disease Known pulmonary disease (to include respiratory infections)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIPPV with nasal cannula<br>Non-invasive positive pressure ventilation with nasal cannula in place | Device: Nasal cannula<br>* Placement of nasal cannula under non-invasive positive pressure ventilation mask<br>* Other names: NC;Device: Non-invasive positive pressure ventilation<br>* Non-invasive positive pressure ventilation<br>* Other names: NIPPV;|
| Active Comparator: NIPPV without nasal cannula<br>Non-invasive positive pressure ventilation without nasal cannula | Device: Non-invasive positive pressure ventilation<br>* Non-invasive positive pressure ventilation<br>* Other names: NIPPV;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Face Mask Leak Measured in Liters Per Minute by the Noninvasive Positive Pressure Ventilation Machine | Face mask leak as measured in liters per minute by the noninvasive positive pressure ventilation machine | 2 minutes after mask placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Discomfort (Verbal Numerical Rating Scale) | Discomfort scored on a 0-10 verbal numerical rating scale (0 = no discomfort, 10 = most discomfort imaginable) | After study completion (approximately 2 minutes after study start) |