Diffuse Apneic Oxygenation
Conditions
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?
Interventions
OTHEROxygen
15 L of oxygen will be delivered to the patient by nasal cannula during the apnea period of rapid sequence intubation.
OTHERStandard of care
Rapid sequence intubation
Sponsors
New York City Health and Hospitals Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean (Average) Arterial Oxygen Saturation | within 2 minutes of confirmation of endotracheal tube placement | the average oxygen saturation as measured by peripheral capillary oxygen saturation (SpO2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Desaturation | within 2 minutes of confirmation of endotracheal tube placement | number of patients per group that desaturated to less than 90% and less than 80% |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Oxygen: 15 L of oxygen will be delivered to the patient by nasal cannula during the apnea period of rapid sequence intubation.
Standard of care: Rapid sequence intubation | 100 |
| Usual Care This group of patients will receive the standard of care treatment of rapid sequence intubation (pre-oxygenation, induction and intubation)
Standard of care: Rapid sequence intubation | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | Usual Care | Total | Apneic Oxygenation |
|---|---|---|---|
| Age, Continuous | 55.1 years | 54.7 years | 54.2 years |
| American Society of Anesthesia Classification | 2.69 units on a scale | 2.68 units on a scale | 2.67 units on a scale |
| Cormack-Lehane Grade/Scale of View | 1.48 units on a scale | 1.44 units on a scale | 1.41 units on a scale |
| Region of Enrollment United States | 100 participants | 200 participants | 100 participants |
| Sex: Female, Male Female | 41 Participants | 83 Participants | 42 Participants |
| Sex: Female, Male Male | 59 Participants | 117 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 14 / 100 | 16 / 100 |
| other Total, other adverse events | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
Mean (Average) Arterial Oxygen Saturation
the average oxygen saturation as measured by peripheral capillary oxygen saturation (SpO2)
Time frame: within 2 minutes of confirmation of endotracheal tube placement
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Apneic Oxygenation | Mean (Average) Arterial Oxygen Saturation | 92 Percent Saturation (SpO2) |
| Usual Care | Mean (Average) Arterial Oxygen Saturation | 93 Percent Saturation (SpO2) |
Secondary
Rates of Desaturation
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
Population: All patients undergoing rapid sequence intubation receiving either Apneic Oxygenation or Usual Care
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Apneic Oxygenation | Rates of Desaturation | Desaturation >=80% | 17 Participants |
| Apneic Oxygenation | Rates of Desaturation | Desaturation <80% | 3 Participants |
| Apneic Oxygenation | Rates of Desaturation | No Desaturation to <90% or 80% | 80 Participants |
| Usual Care | Rates of Desaturation | Desaturation >=80% | 15 Participants |
| Usual Care | Rates of Desaturation | Desaturation <80% | 4 Participants |
| Usual Care | Rates of Desaturation | No Desaturation to <90% or 80% | 81 Participants |