NCT03842306

Brief Summary

Recent studies have shown that end tidal oxygen (ETO2) monitoring can be useful to determine the adequacy of preoxygenation. No study has assessed the correlation between ETO2 values obtained during preoxygenation to predict the PaO2 in patients undergoing RSI in the ED. Our objective was to determine whether a novel equation using the ETO2 at the end of preoxygenation could reliably estimate the partial pressure of arterial oxygen (PaO2) in critically-ill ED patients undergoing RSI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

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

October 15, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

February 12, 2019

Last Update Submit

February 15, 2019

Conditions

Keywords

End tidal oxygenPreoxygenationArterial oxygen

Outcome Measures

Primary Outcomes (1)

  • Correlation of ETO2 to arterial oxygen

    To determine whether a novel equation using the EtO2 measured by a gas analyzer at the time of induction during the preoxygenation phase of ED RSI could reliably estimate the minimal PaO2 in patients undergoing RSI.

    within 2 minutes of rapid sequence intubation

Study Arms (1)

Study Cohort

Patients undergoing rapid sequence intubation in the emergency department for which end tidal oxygen was monitored.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Emergency department patients with a need for endotracheal intubation.

You may qualify if:

  • All patients undergoing rapid sequence intubation.

You may not qualify if:

  • Patients presenting to the emergency department in cardiac or traumatic arrest
  • Patients who received bi-level positive airway pressure (BiPAP) as the primary delivery of preoxygenation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYC H+H/Lincoln

The Bronx, New York, 10451, United States

Location

Related Publications (13)

  • Brown CA 3rd, Bair AE, Pallin DJ, Walls RM; NEAR III Investigators. Techniques, success, and adverse events of emergency department adult intubations. Ann Emerg Med. 2015 Apr;65(4):363-370.e1. doi: 10.1016/j.annemergmed.2014.10.036. Epub 2014 Dec 20.

    PMID: 25533140BACKGROUND
  • Sakles JC. Maintenance of Oxygenation During Rapid Sequence Intubation in the Emergency Department. Acad Emerg Med. 2017 Nov;24(11):1395-1404. doi: 10.1111/acem.13271. Epub 2017 Oct 13. No abstract available.

    PMID: 28791775BACKGROUND
  • Benumof JL, Dagg R, Benumof R. Critical hemoglobin desaturation will occur before return to an unparalyzed state following 1 mg/kg intravenous succinylcholine. Anesthesiology. 1997 Oct;87(4):979-82. doi: 10.1097/00000542-199710000-00034. No abstract available.

    PMID: 9357902BACKGROUND
  • Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.

    PMID: 22050948BACKGROUND
  • Benumof JL. Preoxygenation: best method for both efficacy and efficiency. Anesthesiology. 1999 Sep;91(3):603-5. doi: 10.1097/00000542-199909000-00006. No abstract available.

    PMID: 10485765BACKGROUND
  • Campbell IT, Beatty PC. Monitoring preoxygenation. Br J Anaesth. 1994 Jan;72(1):3-4. doi: 10.1093/bja/72.1.3. No abstract available.

    PMID: 8110546BACKGROUND
  • Bhatia PK, Bhandari SC, Tulsiani KL, Kumar Y. End-tidal oxygraphy and safe duration of apnoea in young adults and elderly patients. Anaesthesia. 1997 Feb;52(2):175-8. doi: 10.1111/j.1365-2044.1997.14-az016.x.

    PMID: 9059106BACKGROUND
  • Farmery AD, Roe PG. A model to describe the rate of oxyhaemoglobin desaturation during apnoea. Br J Anaesth. 1996 Feb;76(2):284-91. doi: 10.1093/bja/76.2.284.

    PMID: 8777112BACKGROUND
  • Groombridge C, Chin CW, Hanrahan B, Holdgate A. Assessment of Common Preoxygenation Strategies Outside of the Operating Room Environment. Acad Emerg Med. 2016 Mar;23(3):342-6. doi: 10.1111/acem.12889. Epub 2016 Feb 17.

    PMID: 26728311BACKGROUND
  • 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
  • Mort TC. Preoxygenation in critically ill patients requiring emergency tracheal intubation. Crit Care Med. 2005 Nov;33(11):2672-5. doi: 10.1097/01.ccm.0000187131.67594.9e.

    PMID: 16276196BACKGROUND
  • Mort TC. The incidence and risk factors for cardiac arrest during emergency tracheal intubation: a justification for incorporating the ASA Guidelines in the remote location. J Clin Anesth. 2004 Nov;16(7):508-16. doi: 10.1016/j.jclinane.2004.01.007.

    PMID: 15590254BACKGROUND
  • Mosier JM, Hypes CD, Sakles JC. Understanding preoxygenation and apneic oxygenation during intubation in the critically ill. Intensive Care Med. 2017 Feb;43(2):226-228. doi: 10.1007/s00134-016-4426-0. Epub 2016 Jun 24. No abstract available.

    PMID: 27342820BACKGROUND

Study Officials

  • Nicholas Caputo, MD

    NYC H+H/Lincoln

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2019

First Posted

February 15, 2019

Study Start

October 15, 2017

Primary Completion

December 30, 2017

Study Completion

December 30, 2017

Last Updated

February 18, 2019

Record last verified: 2019-02

Locations