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

Primary Purpose

Diffuse Apneic Oxygenation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxygen
Standard of care
Sponsored by
New York City Health and Hospitals Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Apneic Oxygenation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Lincoln Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Diffuse apneic oxygenation

Usual care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Mean (Average) Arterial Oxygen Saturation
the average oxygen saturation as measured by peripheral capillary oxygen saturation (SpO2)

Secondary Outcome Measures

Rates of Desaturation
number of patients per group that desaturated to less than 90% and less than 80%

Full Information

First Posted
April 5, 2016
Last Updated
March 4, 2019
Sponsor
New York City Health and Hospitals Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02737917
Brief Title
EmergeNcy Department Apneic Oxygenation Versus Usual Care During Rapid Sequence Intubation
Acronym
ENDAO
Official Title
EmergeNcy Department Apneic Oxygenation Versus Usual Care During Rapid Sequence Intubation : A Randomized Controlled Trial (The ENDAO Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York City Health and Hospitals Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Apneic Oxygenation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diffuse apneic oxygenation
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Other
Arm Description
This group of patients will receive the standard of care treatment of rapid sequence intubation (pre-oxygenation, induction and intubation)
Intervention Type
Other
Intervention Name(s)
Oxygen
Intervention Description
15 L of oxygen will be delivered to the patient by nasal cannula during the apnea period of rapid sequence intubation.
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Rapid sequence intubation
Primary Outcome Measure Information:
Title
Mean (Average) Arterial Oxygen Saturation
Description
the average oxygen saturation as measured by peripheral capillary oxygen saturation (SpO2)
Time Frame
within 2 minutes of confirmation of endotracheal tube placement
Secondary Outcome Measure Information:
Title
Rates of Desaturation
Description
number of patients per group that desaturated to less than 90% and less than 80%
Time Frame
within 2 minutes of confirmation of endotracheal tube placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Scott, MD
Organizational Affiliation
NYCHHC/Lincoln
Official's Role
Study Chair
Facility Information:
Facility Name
Lincoln Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10451
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to make individual participant data available
Citations:
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Citation
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EmergeNcy Department Apneic Oxygenation Versus Usual Care During Rapid Sequence Intubation

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