Preoxygenation With Nasal Cannula and Noninvasive Positive Pressure Ventilation

Hypoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03093662
• Other study ID #: C.2017.011
• Status: Completed
• Phase: N/A
• Start date: March 2, 2017
• Est. completion date: March 9, 2017

Study information

• Verified date: January 2021
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 9, 2017
• Est. primary completion date: March 9, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypoxia

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. Epub 2006 Apr 20. — View Citation

Bodily JB, Webb HR, Weiss SJ, Braude DA. Incidence and Duration of Continuously Measured Oxygen Desaturation During Emergency Department Intubation. Ann Emerg Med. 2016 Mar;67(3):389-95. doi: 10.1016/j.annemergmed.2015.06.006. Epub 2015 Jul 9. — View Citation

Hayes-Bradley C, Lewis A, Burns B, Miller M. Efficacy of Nasal Cannula Oxygen as a Preoxygenation Adjunct in Emergency Airway Management. Ann Emerg Med. 2016 Aug;68(2):174-80. doi: 10.1016/j.annemergmed.2015.11.012. Epub 2015 Dec 31. — View Citation

Sakles JC, Mosier JM, Patanwala AE, Arcaris B, Dicken JM. First Pass Success Without Hypoxemia Is Increased With the Use of Apneic Oxygenation During Rapid Sequence Intubation in the Emergency Department. Acad Emerg Med. 2016 Jun;23(6):703-10. doi: 10.1111/acem.12931. Epub 2016 May 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	End-tidal Oxygen	Measured by exhalation into sensor (Maxtec Max-250E)	3 minutes after study start