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Preoxygenation With Nasal Cannula and Noninvasive Positive Pressure Ventilation

Primary Purpose

Hypoxia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ventilation with nasal cannula
Ventilation without nasal cannula
Sponsored by
Brooke Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypoxia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Brooke Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ventilation with nasal cannula

Ventilation without nasal cannula

Arm Description

Non-invasive positive pressure ventilation with nasal cannula.

Non-invasive positive pressure ventilation without nasal cannula.

Outcomes

Primary Outcome Measures

End-tidal Oxygen
Measured by exhalation into sensor (Maxtec Max-250E)

Secondary Outcome Measures

Full Information

First Posted
March 22, 2017
Last Updated
January 25, 2021
Sponsor
Brooke Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03093662
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2, 2017 (Actual)
Primary Completion Date
March 9, 2017 (Actual)
Study Completion Date
March 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brooke Army Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ventilation with nasal cannula
Arm Type
Experimental
Arm Description
Non-invasive positive pressure ventilation with nasal cannula.
Arm Title
Ventilation without nasal cannula
Arm Type
Active Comparator
Arm Description
Non-invasive positive pressure ventilation without nasal cannula.
Intervention Type
Device
Intervention Name(s)
Ventilation with nasal cannula
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Ventilation without nasal cannula
Intervention Description
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).
Primary Outcome Measure Information:
Title
End-tidal Oxygen
Description
Measured by exhalation into sensor (Maxtec Max-250E)
Time Frame
3 minutes after study start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek J Brown, MD
Organizational Affiliation
United States Army Institute of Surgical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16627862
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.
Results Reference
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PubMed Identifier
26836712
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.
Results Reference
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PubMed Identifier
26164643
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.
Results Reference
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PubMed Identifier
26747218
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.
Results Reference
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Preoxygenation With Nasal Cannula and Noninvasive Positive Pressure Ventilation

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