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EmergeNcy Department Apneic Oxygenation Versus Usual Care During Rapid Sequence Intubation (ENDAO)

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ClinicalTrials.gov Identifier: NCT02737917
Recruitment Status : Completed
First Posted : April 14, 2016
Results First Posted : March 4, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
New York City Health and Hospitals Corporation

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.

Condition or disease Intervention/treatment Phase
Diffuse Apneic Oxygenation Other: Oxygen Other: Standard of care Not Applicable

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?


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EmergeNcy Department Apneic Oxygenation Versus Usual Care During Rapid Sequence Intubation : A Randomized Controlled Trial (The ENDAO Trial)
Study Start Date : May 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: 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.
Other: Oxygen
15 L of oxygen will be delivered to the patient by nasal cannula during the apnea period of rapid sequence intubation.

Other: Standard of care
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)
Other: Standard of care
Rapid sequence intubation




Primary Outcome Measures :
  1. Mean (Average) Arterial Oxygen Saturation [ Time Frame: within 2 minutes of confirmation of endotracheal tube placement ]
    the average oxygen saturation as measured by peripheral capillary oxygen saturation (SpO2)


Secondary Outcome Measures :
  1. Rates of Desaturation [ Time Frame: within 2 minutes of confirmation of endotracheal tube placement ]
    number of patients per group that desaturated to less than 90% and less than 80%



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737917


Locations
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United States, New York
Lincoln Medical Center
Bronx, New York, United States, 10451
Sponsors and Collaborators
New York City Health and Hospitals Corporation
Investigators
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Study Chair: Sandra Scott, MD NYCHHC/Lincoln

Publications:

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Responsible Party: New York City Health and Hospitals Corporation
ClinicalTrials.gov Identifier: NCT02737917     History of Changes
Other Study ID Numbers: IRB #16-003
First Posted: April 14, 2016    Key Record Dates
Results First Posted: March 4, 2019
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to make individual participant data available
Additional relevant MeSH terms:
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Apnea
Emergencies
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms