Clinical trial NCT02743936: Mask Leak With Nasal Cannula in Noninvasive Positive Pressure Ventilation
Official title: Analysis of Face Mask Leak With Nasal Cannula in Noninvasive Positive Pressure Ventilation: A Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mechanical Ventilation Pressure High
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2016-04-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age
* Volunteer for study

Exclusion Criteria:

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

Primary outcomes:
measure: Face Mask Leak Measured in Liters Per Minute by the Noninvasive Positive Pressure Ventilation Machine
timeFrame: 2 minutes after mask placement
Secondary outcomes:
measure: Patient Discomfort (Verbal Numerical Rating Scale)
timeFrame: After study completion (approximately 2 minutes after study start)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: San Antonio Military Medical Center
state: Texas
Study officials:
affiliation: Brooke Army Medical Center
name: Michael D April, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.
citation: Baillard C, Fosse JP, Sebbane M, Chanques G, Vincent F, Courouble P, Cohen Y, Eledjam JJ, Adnet F, Jaber S. Noninvasive ventilation improves preoxygenation before intubation of hypoxic patients. Am J Respir Crit Care Med. 2006 Jul 15;174(2):171-7. doi: 10.1164/rccm.200509-1507OC. Epub 2006 Apr 20.
citation: Ramachandran SK, Cosnowski A, Shanks A, Turner CR. Apneic oxygenation during prolonged laryngoscopy in obese patients: a randomized, controlled trial of nasal oxygen administration. J Clin Anesth. 2010 May;22(3):164-8. doi: 10.1016/j.jclinane.2009.05.006.
citation: Lawes EG, Campbell I, Mercer D. Inflation pressure, gastric insufflation and rapid sequence induction. Br J Anaesth. 1987 Mar;59(3):315-8. doi: 10.1093/bja/59.3.315.