Mask Leak With Nasal Cannula in Noninvasive Positive Pressure Ventilation

Phase 4

Completed

• Conditions: Mechanical Ventilation Pressure High
• Interventions: Device: Nasal cannula; Device: Non-invasive positive pressure ventilation

• Registration Number: NCT02743936
• Lead Sponsor: Brooke Army Medical Center

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-15
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-19
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Results First Submitted: 2016-07-08
• Results First Submitted QC: 2016-07-08
• Status Verified: 2016-08
• Results First Posted: 2016-08-18
• Last Update Submitted: 2016-08-18
• Last Update Posted: 2016-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• 18 years of age
• Volunteer for study

Exclusion Criteria

• Known cardiac disease
• Known pulmonary disease (to include respiratory infections)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NIPPV with nasal cannula	Non-invasive positive pressure ventilation	Non-invasive positive pressure ventilation with nasal cannula in place
NIPPV with nasal cannula	Nasal cannula	Non-invasive positive pressure ventilation with nasal cannula in place
NIPPV without nasal cannula	Non-invasive positive pressure ventilation	Non-invasive positive pressure ventilation without nasal cannula

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

San Antonio Military Medical Center; 🇺🇸 San Antonio, Texas, United States