NCT03093662

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2017

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

December 28, 2020

Completed
Last Updated

February 12, 2021

Status Verified

January 1, 2021

Enrollment Period

7 days

First QC Date

March 22, 2017

Results QC Date

July 8, 2019

Last Update Submit

January 25, 2021

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (1)

  • End-tidal Oxygen

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

    3 minutes after study start

Study Arms (2)

Ventilation with nasal cannula

EXPERIMENTAL

Non-invasive positive pressure ventilation with nasal cannula.

Device: Ventilation with nasal cannulaDevice: Ventilation without nasal cannula

Ventilation without nasal cannula

ACTIVE COMPARATOR

Non-invasive positive pressure ventilation without nasal cannula.

Device: Ventilation with nasal cannulaDevice: Ventilation without nasal cannula

Interventions

Ventilation with nasal cannulaDEVICE

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 with nasal cannulaVentilation without nasal cannula
Ventilation without nasal cannulaDEVICE

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).

Ventilation with nasal cannulaVentilation without nasal cannula

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any healthy volunteer aged 18-65 years.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Related 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. doi: 10.1164/rccm.200509-1507OC. Epub 2006 Apr 20.

    PMID: 16627862BACKGROUND

  • 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.

    PMID: 26836712BACKGROUND

  • 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.

    PMID: 26164643BACKGROUND

  • 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.

    PMID: 26747218BACKGROUND

MeSH Terms

Conditions

Hypoxia

Interventions

Cannula

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CathetersEquipment and Supplies

Results Point of Contact

Title
Dr. Derek Brown
Organization
Brooke Army Medical Center
Derek.J.Brown1.mil@mail.mil
2109160808

Study Officials

  • Derek J Brown, MD

    United States Army Institute of Surgical Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Program Director for Research, Emergency Medicine

Study Record Dates

First Submitted

March 22, 2017

First Posted

March 28, 2017

Study Start

March 2, 2017

Primary Completion

March 9, 2017

Study Completion

March 9, 2017

Last Updated

February 12, 2021

Results First Posted

December 28, 2020

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)