EmergeNcy Department Apneic Oxygenation Versus Usual Care During Rapid Sequence Intubation

NCT ID: NCT02737917

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2016-12-31

Brief Summary

To determine the impact, if any the application of oxygen during the apnea period of rapid sequence intubation has on patients being intubated in the emergency department.

Detailed Description

Hypoxia may occur during rapid sequence intubation (RSI) of emergency department patients (1-4). This condition may increase the risk of the patient suffering a cardiac arrest secondary to securing the airway. A part of RSI is pre-oxygenation, which is defined as placing the patient on 100% fraction of inspired O2 for 3 minutes prior to administering the induction agents (i.e. sedative and neuromuscular blocker) in order to increase the amount of oxygen present in the functional residual capacity of the patients lungs to prolong oxygen saturating during the apneic period of endotracheal intubation (5-9). In the last decade, physicians have developed a process known as diffuse apneic oxygenation (DAO) in order to mitigate the risk of oxygen desaturation during this apneic period. The process entails leaving the patient on high flow nasal cannula (HFNC) oxygen during the act of visualizing the vocal cords and placing the endotracheal tube. Over the years the practice has started to become more common in emergency departments, operating rooms and ICU's all over the world. Recently, a randomized controlled trial (called The FELLOW Trial) of this practice demonstrated no difference in desaturation rates between those patients that received DAO and those that did not (usual practice) in patients in the ICU (10). Some have commented that the findings of this study cannot be applied to emergency department patients, and so evidence is lacking in regards to this population.

Purpose of the study:

Although studies have started to investigate the efficacy of DAO in preventing desaturation during RSI, evidence is still lacking in the emergency department patient population. The primary question being asked is: does diffuse apneic oxygenation increase the average lowest arterial oxygen saturation during rapid sequence intubation when compared to usual care? Secondary question being asked is: does diffuse apneic oxygenation decrease the incidence of desaturation in general, as well as hypoxemia and severe hypoxemia? The third question being asked is: does diffuse apneic oxygenation increase the time to desaturation?

Conditions

Diffuse Apneic Oxygenation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Diffuse apneic oxygenation

This group of patients will receive the standard of care treatment of rapid sequence intubation (pre-oxygenation, induction and intubation) plus the application of oxygen.

Group Type: EXPERIMENTAL

Oxygen

Intervention Type: OTHER

15 L of oxygen will be delivered to the patient by nasal cannula during the apnea period of rapid sequence intubation.

Standard of care

Intervention Type: OTHER

Rapid sequence intubation

Usual care

This group of patients will receive the standard of care treatment of rapid sequence intubation (pre-oxygenation, induction and intubation)

Group Type: OTHER

Standard of care

Intervention Type: OTHER

Rapid sequence intubation

Interventions

Oxygen

15 L of oxygen will be delivered to the patient by nasal cannula during the apnea period of rapid sequence intubation.

Intervention Type: OTHER

Standard of care

Rapid sequence intubation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Any patient greater than 18 years of age that presents to the Lincoln medical and Mental Health Center Emergency Department requiring endotracheal intubation.

Exclusion Criteria

Patients will be excluded from the primary outcome analysis, but included in the intention to treat analysis for the secondary outcome if they are not pre-oxygenated to the standard RSI protocol of 3 minutes with 100% fraction of inspired oxygen (FiO2) by means of bag valve mask, HFNC and/or non-rebreather; patients will be excluded from the study in general if they are in cardiac or traumatic arrest or they are intubated without an apneic period (awake intubation)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York City Health and Hospitals Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra Scott, MD

Role: STUDY_CHAIR

NYCHHC/Lincoln

Locations

Lincoln Medical Center

The Bronx, New York, United States

Countries

United States

References

Jaber S, Amraoui J, Lefrant JY, Arich C, Cohendy R, Landreau L, Calvet Y, Capdevila X, Mahamat A, Eledjam JJ. Clinical practice and risk factors for immediate complications of endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Crit Care Med. 2006 Sep;34(9):2355-61. doi: 10.1097/01.CCM.0000233879.58720.87.

Reference Type: BACKGROUND

PMID: 16850003 (View on PubMed)

Griesdale DE, Bosma TL, Kurth T, Isac G, Chittock DR. Complications of endotracheal intubation in the critically ill. Intensive Care Med. 2008 Oct;34(10):1835-42. doi: 10.1007/s00134-008-1205-6. Epub 2008 Jul 5.

Reference Type: BACKGROUND

PMID: 18604519 (View on PubMed)

Simpson GD, Ross MJ, McKeown DW, Ray DC. Tracheal intubation in the critically ill: a multi-centre national study of practice and complications. Br J Anaesth. 2012 May;108(5):792-9. doi: 10.1093/bja/aer504. Epub 2012 Feb 6.

Reference Type: BACKGROUND

PMID: 22315326 (View on PubMed)

De Jong A, Molinari N, Terzi N, Mongardon N, Arnal JM, Guitton C, Allaouchiche B, Paugam-Burtz C, Constantin JM, Lefrant JY, Leone M, Papazian L, Asehnoune K, Maziers N, Azoulay E, Pradel G, Jung B, Jaber S; AzuRea Network for the Frida-Rea Study Group. Early identification of patients at risk for difficult intubation in the intensive care unit: development and validation of the MACOCHA score in a multicenter cohort study. Am J Respir Crit Care Med. 2013 Apr 15;187(8):832-9. doi: 10.1164/rccm.201210-1851OC.

Reference Type: BACKGROUND

PMID: 23348979 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16627862 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16276196 (View on PubMed)

Mort TC, Waberski BH, Clive J. Extending the preoxygenation period from 4 to 8 mins in critically ill patients undergoing emergency intubation. Crit Care Med. 2009 Jan;37(1):68-71. doi: 10.1097/CCM.0b013e318192845e.

Reference Type: BACKGROUND

PMID: 19050620 (View on PubMed)

Vourc'h M, Asfar P, Volteau C, Bachoumas K, Clavieras N, Egreteau PY, Asehnoune K, Mercat A, Reignier J, Jaber S, Prat G, Roquilly A, Brule N, Villers D, Bretonniere C, Guitton C. High-flow nasal cannula oxygen during endotracheal intubation in hypoxemic patients: a randomized controlled clinical trial. Intensive Care Med. 2015 Sep;41(9):1538-48. doi: 10.1007/s00134-015-3796-z. Epub 2015 Apr 14.

Reference Type: BACKGROUND

PMID: 25869405 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22050948 (View on PubMed)

Semler MW, Janz DR, Lentz RJ, Matthews DT, Norman BC, Assad TR, Keriwala RD, Ferrell BA, Noto MJ, McKown AC, Kocurek EG, Warren MA, Huerta LE, Rice TW; FELLOW Investigators; Pragmatic Critical Care Research Group. Randomized Trial of Apneic Oxygenation during Endotracheal Intubation of the Critically Ill. Am J Respir Crit Care Med. 2016 Feb 1;193(3):273-80. doi: 10.1164/rccm.201507-1294OC.

Reference Type: BACKGROUND

PMID: 26426458 (View on PubMed)

Ramachandran SK, Cosnowski A, Shanks A, Turner CR. Apneic oxygenation during prolonged laryngoscopy in obese patients: a randomized, controlled trial of nasal oxygen administration. J Clin Anesth. 2010 May;22(3):164-8. doi: 10.1016/j.jclinane.2009.05.006.

Reference Type: BACKGROUND

PMID: 20400000 (View on PubMed)

Other Identifiers

IRB #16-003

Identifier Type: -

Identifier Source: org_study_id