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Completed

NCT Number: NCT02743936

Mask Leak With Nasal Cannula in Noninvasive Positive Pressure Ventilation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

San Antonio Military Medical Center

San Antonio, Texas, 78234, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age
  • Volunteer for study

Exclusion criteria

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

Treatment and study plan

Nasal Cannula

Device

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

Other names: NC

Non-invasive positive pressure ventilation

Device

Non-invasive positive pressure ventilation

Other names: NIPPV

Primary outcomes

  1. Face Mask Leak Measured in Liters Per Minute by the Noninvasive Positive Pressure Ventilation Machine

    Time frame: 2 minutes after mask placement

    Face mask leak as measured in liters per minute by the noninvasive positive pressure ventilation machine

Secondary outcomes

  1. Patient Discomfort (Verbal Numerical Rating Scale)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Brooke Army Medical Center

Fed

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 19, 2016
Registry last updated
Sep 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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