NCT03093662

Preoxygenation With Nasal Cannula and Noninvasive Positive Pressure Ventilation

Analysis of Preoxygenation Combining Nasal Cannula With Noninvasive Positive Pressure Ventilation: A Randomized Crossover Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Brooke Army Medical Center · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a prospective randomized cross over study of healthy volunteers comparing end-tidal oxygen concentration among subjects undergoing continuous positive airway pressure ventilation via a noninvasive ventilation (NIV) mask with and without the addition of nasal cannulas.

Detailed description

Noninvasive positive pressure ventilation with the addition of a nasal cannula is a useful technique to pre-oxygenate and provide apneic oxygenation in hypoxic patients undergoing emergency airway management. This study aims to evaluate preoxygenation by quantifying end-tidal oxygen (etO2) concentration resulting from nasal cannula placement underneath a noninvasive positive pressure ventilation (NIPPV) mask. 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. End-tidal oxygen concentration will be measured by an oxygen sensor following three minutes of NIPPV with and without the addition of a nasal cannula, with each subject serving as his or her own control.

Conditions

• Hypoxia

Interventions

Type	Name	Description
DEVICE	Ventilation with nasal cannula	Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear) while simultaneously wearing nasal cannula (Carefusion AirLife Standard Nasal Cannula) with 15 L/min oxygen flow. Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).
DEVICE	Ventilation without nasal cannula	Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear). Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).

Timeline

• Start date: 2017-03-02
• Primary completion: 2017-03-09
• Completion: 2017-03-09
• First posted: 2017-03-28
• Last updated: 2021-02-12
• Results posted: 2020-12-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study