- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03842306
End-tidal Oxygen Can Reliably Predict the Arterial Partial Pressure of Oxygen Among Emergency Department Patients
February 15, 2019 updated by: New York City Health and Hospitals Corporation
End-tidal Oxygen Can Reliably Predict the Arterial Partial Pressure of Oxygen Among Emergency Department Patients Undergoing Rapid Sequence Intubation
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Rapid Sequence Intubation (RSI) is the preferred and most commonly-used method of definitive airway management among critically ill emergency department (ED) patients requiring intubation.
Adequate preoxygenation is intended to prolong the safe apnoeic period.
Optimal preoxygenation for ED patient undergoing RSI is best described as a two-part process of denitrogenation of the functional residual capacity (FRC) and the formation of an oxygen reservoir within the alveoli.
End-tidal O2 (EtO2) has been shown to be a reliable surrogate marker for denitrogenation.
Most of the literature supporting EtO2 as an adequate maker of adequate preoxygenation has been conducted in the operating room setting.
This population varies significantly from the population requiring endotracheal intubation in the ED.
Our study aim was to show that the use of a gas analyzer measuring the fraction of inspired oxygen (FiO2) and EtO2 during the preoxygenation phase of ED RSI can reliably predict the minimal PaO2 at the end of the ED preoxygenation period.
Study Type
Observational
Enrollment (Actual)
75
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Bronx, New York, United States, 10451
- NYC H+H/Lincoln
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Emergency department patients with a need for endotracheal intubation.
Description
Inclusion Criteria:
- All patients undergoing rapid sequence intubation.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Study Cohort
Patients undergoing rapid sequence intubation in the emergency department for which end tidal oxygen was monitored.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of ETO2 to arterial oxygen
Time Frame: within 2 minutes of rapid sequence intubation
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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.
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within 2 minutes of rapid sequence intubation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nicholas Caputo, MD, NYC H+H/Lincoln
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Br J Anaesth 1994 May;72(5):612.
- 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.
- 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. Erratum In: Ann Emerg Med. 2017 May;69(5):540.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Br J Anaesth 1996 Jun;76(6):890.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2017
Primary Completion (Actual)
December 30, 2017
Study Completion (Actual)
December 30, 2017
Study Registration Dates
First Submitted
February 12, 2019
First Submitted That Met QC Criteria
February 12, 2019
First Posted (Actual)
February 15, 2019
Study Record Updates
Last Update Posted (Actual)
February 18, 2019
Last Update Submitted That Met QC Criteria
February 15, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-031
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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