Trial Outcomes & Findings for EmergeNcy Department Apneic Oxygenation Versus Usual Care During Rapid Sequence Intubation (NCT NCT02737917)

NCT ID: NCT02737917

Last Updated: 2019-03-19

Results Overview

the average oxygen saturation as measured by peripheral capillary oxygen saturation (SpO2)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 206 participants
• Primary outcome timeframe: within 2 minutes of confirmation of endotracheal tube placement
• Results posted on: 2019-03-19

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	103	103
Overall Study COMPLETED	100	100
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

EmergeNcy Department Apneic Oxygenation Versus Usual Care During Rapid Sequence Intubation

Baseline characteristics by cohort

Measure	Apneic Oxygenation n=100 Participants 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	Usual Care n=100 Participants 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	Total n=200 Participants Total of all reporting groups
Age, Continuous	54.2 years n=93 Participants	55.1 years n=4 Participants	54.7 years n=27 Participants
Sex: Female, Male Female	42 Participants n=93 Participants	41 Participants n=4 Participants	83 Participants n=27 Participants
Sex: Female, Male Male	58 Participants n=93 Participants	59 Participants n=4 Participants	117 Participants n=27 Participants
Region of Enrollment United States	100 participants n=93 Participants	100 participants n=4 Participants	200 participants n=27 Participants
American Society of Anesthesia Classification	2.67 units on a scale n=93 Participants	2.69 units on a scale n=4 Participants	2.68 units on a scale n=27 Participants
Cormack-Lehane Grade/Scale of View	1.41 units on a scale n=93 Participants	1.48 units on a scale n=4 Participants	1.44 units on a scale n=27 Participants

PRIMARY outcome

Timeframe: within 2 minutes of confirmation of endotracheal tube placement

the average oxygen saturation as measured by peripheral capillary oxygen saturation (SpO2)

Outcome measures

Measure	Apneic Oxygenation n=100 Participants 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	Usual Care n=100 Participants 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
Mean (Average) Arterial Oxygen Saturation	92 Percent Saturation (SpO2) Interval 91.0 to 93.0	93 Percent Saturation (SpO2) Interval 92.0 to 94.0

SECONDARY outcome

Timeframe: within 2 minutes of confirmation of endotracheal tube placement

Population: All patients undergoing rapid sequence intubation receiving either Apneic Oxygenation or Usual Care

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

Outcome measures

Measure	Apneic Oxygenation n=100 Participants 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	Usual Care n=100 Participants 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
Rates of Desaturation Desaturation <80%	3 Participants	4 Participants
Rates of Desaturation Desaturation >=80%	17 Participants	15 Participants
Rates of Desaturation No Desaturation to <90% or 80%	80 Participants	81 Participants

Adverse Events

Apneic Oxygenation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 14 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 16 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nicholas Caputo

Lincoln Medical Center

Phone: 718-579-6010

Email: ncaputo.md@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place