Clinical trial NCT02737917: EmergeNcy Department Apneic Oxygenation Versus Usual Care During Rapid Sequence Intubation
Official title: EmergeNcy Department Apneic Oxygenation Versus Usual Care During Rapid Sequence Intubation : A Randomized Controlled Trial (The ENDAO Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diffuse Apneic Oxygenation
Lead sponsor: New York City Health and Hospitals Corporation
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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)

Primary outcomes:
measure: Mean (Average) Arterial Oxygen Saturation
timeFrame: within 2 minutes of confirmation of endotracheal tube placement
Secondary outcomes:
measure: Rates of Desaturation
timeFrame: within 2 minutes of confirmation of endotracheal tube placement
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Lincoln Medical Center
state: New York
Study officials:
affiliation: NYCHHC/Lincoln
name: Sandra Scott, MD
role: STUDY_CHAIR
References:
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citation: 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.
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