Clinical trial NCT03093662: Preoxygenation With Nasal Cannula and Noninvasive Positive Pressure Ventilation
Official title: Analysis of Preoxygenation Combining Nasal Cannula With Noninvasive Positive Pressure Ventilation: A Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2017-03-28
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: End-tidal Oxygen
timeFrame: 3 minutes after study start
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: United States Army Institute of Surgical Research
name: Derek J Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.