Mask Leak With Nasal Cannula in Noninvasive Positive Pressure Ventilation

NCT ID: NCT02743936

Last Updated: 2016-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-05-31

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.

Conditions

Mechanical Ventilation Pressure High

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

NIPPV with nasal cannula

Non-invasive positive pressure ventilation with nasal cannula in place

Group Type: EXPERIMENTAL

Nasal cannula

Intervention Type: DEVICE

Placement of nasal cannula under non-invasive positive pressure ventilation mask

Non-invasive positive pressure ventilation

Intervention Type: DEVICE

Non-invasive positive pressure ventilation

NIPPV without nasal cannula

Non-invasive positive pressure ventilation without nasal cannula

Group Type: ACTIVE_COMPARATOR

Non-invasive positive pressure ventilation

Intervention Type: DEVICE

Non-invasive positive pressure ventilation

Interventions

Nasal cannula

Placement of nasal cannula under non-invasive positive pressure ventilation mask

Intervention Type: DEVICE

Non-invasive positive pressure ventilation

Non-invasive positive pressure ventilation

Intervention Type: DEVICE

Other Intervention Names

NC; NIPPV

Eligibility Criteria

Inclusion Criteria

• 18 years of age
• Volunteer for study

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brooke Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Michael D. April

Assistant Program Director for Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael D April, MD, PhD, MSc

Role: PRINCIPAL_INVESTIGATOR

Brooke Army Medical Center

Locations

San Antonio Military Medical Center

San Antonio, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22050948 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16627862 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20400000 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3828180 (View on PubMed)

Other Identifiers

C.2016.030d

Identifier Type: -

Identifier Source: org_study_id