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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03842306
Other study ID # 17-031
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 15, 2017
Est. completion date December 30, 2017

Study information

Verified date February 2019
Source New York City Health and Hospitals Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date December 30, 2017
Est. primary completion date December 30, 2017
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States NYC H+H/Lincoln Bronx New York

Sponsors (1)

Lead Sponsor Collaborator
New York City Health and Hospitals Corporation

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

Benumof JL. Preoxygenation: best method for both efficacy and efficiency. Anesthesiology. 1999 Sep;91(3):603-5. — View Citation

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. — View 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. — View Citation

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. — View Citation

Campbell IT, Beatty PC. Monitoring preoxygenation. Br J Anaesth. 1994 Jan;72(1):3-4. Erratum in: Br J Anaesth 1994 May;72(5):612. — View Citation

Farmery AD, Roe PG. A model to describe the rate of oxyhaemoglobin desaturation during apnoea. Br J Anaesth. 1996 Feb;76(2):284-91. Erratum in: Br J Anaesth 1996 Jun;76(6):890. — View Citation

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. — View Citation

Mort TC. Preoxygenation in critically ill patients requiring emergency tracheal intubation. Crit Care Med. 2005 Nov;33(11):2672-5. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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