Preoxygenation With Nasal Cannula and Noninvasive Positive Pressure Ventilation

Not Applicable

Completed

• Conditions: Hypoxia
• Interventions: Device: Ventilation with nasal cannula; Device: Ventilation without nasal cannula

• Registration Number: NCT03093662
• Lead Sponsor: Brooke Army Medical Center

Brief 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.

Study Timeline

• Study Start: 2017-03-02
• Primary Completion: 2017-03-09
• Study Completion: 2017-03-09
• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-03-22
• Study First Posted: 2017-03-28
• Results First Submitted: 2019-07-08
• Results First Submitted QC: 2020-12-24
• Results First Posted: 2020-12-28
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Any healthy volunteer aged 18-65 years.

Exclusion Criteria

• Previous inability to tolerate noninvasive positive pressure ventilation with addition of a nasal cannula.
• Known underlying cardiac or pulmonary disease.
• Active respiratory infections.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ventilation with nasal cannula	Ventilation without nasal cannula	Non-invasive positive pressure ventilation with nasal cannula.
Ventilation without nasal cannula	Ventilation without nasal cannula	Non-invasive positive pressure ventilation without nasal cannula.
Ventilation with nasal cannula	Ventilation with nasal cannula	Non-invasive positive pressure ventilation with nasal cannula.
Ventilation without nasal cannula	Ventilation with nasal cannula	Non-invasive positive pressure ventilation without nasal cannula.

Primary Outcome Measures

Name	Time	Method
End-tidal Oxygen	3 minutes after study start	Measured by exhalation into sensor (Maxtec Max-250E)

Trial Locations

Locations (1)

Brooke Army Medical Center; 🇺🇸 Fort Sam Houston, Texas, United States