NCT02743936

Mask Leak With Nasal Cannula in Noninvasive Positive Pressure Ventilation

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Brooke Army Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Mechanical Ventilation Pressure High

Interventions

Type	Name	Description
DEVICE	Nasal cannula	Placement of nasal cannula under non-invasive positive pressure ventilation mask
DEVICE	Non-invasive positive pressure ventilation	Non-invasive positive pressure ventilation

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2016-04-19
• Last updated: 2016-09-26
• Results posted: 2016-08-18

Locations

1 site across 1 country: United States