NCT02743936

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
4 months until next milestone

Results Posted

Study results publicly available

August 18, 2016

Completed
Last Updated

September 26, 2016

Status Verified

August 1, 2016

Enrollment Period

1 month

First QC Date

April 15, 2016

Results QC Date

July 8, 2016

Last Update Submit

August 18, 2016

Conditions

Mechanical Ventilation Pressure High

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Patient Discomfort (Verbal Numerical Rating Scale)

    After study completion (approximately 2 minutes after study start)

Study Arms (2)

NIPPV with nasal cannula

EXPERIMENTAL

Non-invasive positive pressure ventilation with nasal cannula in place

Device: Nasal cannulaDevice: Non-invasive positive pressure ventilation

NIPPV without nasal cannula

ACTIVE COMPARATOR

Non-invasive positive pressure ventilation without nasal cannula

Device: Non-invasive positive pressure ventilation

Interventions

Nasal cannulaDEVICE

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

Also known as: NC
NIPPV with nasal cannula
Non-invasive positive pressure ventilationDEVICE

Non-invasive positive pressure ventilation

Also known as: NIPPV
NIPPV with nasal cannulaNIPPV without nasal cannula

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Volunteer for study

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Antonio Military Medical Center

San Antonio, Texas, 78234, United States

Location

Related Publications (4)

  • 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.

    PMID: 22050948BACKGROUND

  • 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.

    PMID: 16627862BACKGROUND

  • 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.

    PMID: 20400000BACKGROUND

  • 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.

    PMID: 3828180BACKGROUND

MeSH Terms

Interventions

Cannula

Intervention Hierarchy (Ancestors)

CathetersEquipment and Supplies

Results Point of Contact

Title
Dr. Michael D. April
Organization
Brooke Army Medical Center
Michael.D.April@post.harvard.edu
210-916-0808

Study Officials

  • Michael D April, MD, PhD, MSc

    Brooke Army Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Program Director for Research

Study Record Dates

First Submitted

April 15, 2016

First Posted

April 19, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 26, 2016

Results First Posted

August 18, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)