Apneic Oxygenation Including Precipitous Intubations During RSI in the ED

Endotracheal Intubation Clinical Trial

— RAPID  

Official title:

Randomized Controlled Trial of Apneic Oxygenation Including Precipitous Intubations During RSI in the Emergency Department

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03694379
• Other study ID #: Pro2018000579
• Status: Terminated
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 22, 2020

Study information

• Verified date: March 2020
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This RCT is testing the efficacy of apneic oxygenation during endotracheal intubation in the emergency department. Currently the standard practice in the ED when performing endotracheal intubation is that some providers use apneic oxygenation (the application of a nasal cannula at 15LPM) throughout the intubation procedure, while others do not apply apneic oxygenation. Initial literature in the operating room showed that apneic oxygenation helps prevent desaturation during the procedure. However, the latest literature conducted in critical care settings (one study in the ICU and one in the ED) questions the efficacy of this intervention in critically ill patients; however, no harm has been shown. Our study aims to test this intervention further by adding in a special subset of patients that was excluded from prior studies, precipitous intubations, or those patients that have to be intubated quickly and cannot have adequate pre-oxygenation. We hypothesize that apneic oxygenation will be more efficacious in this subset than in the overall ED population. We will randomize patients requiring endotracheal intubation into intervention (apneic oxygenation) and control (no apneic oxygenation). We will measure the lowest arterial oxygen saturation from the start of the intubation procedure through 2 minutes after intubation is complete.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 22, 2020
• Est. primary completion date: March 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The inclusion criteria for our study will include patients 18 years or older who require emergent endotracheal intubation utilizing rapid sequence intubation (RSI) in the Emergency Department with first attempt taken by a resident or attending physician working in the emergency department. This includes Emergency Medicine attending physicians and residents as well as non-Emergency Medicine rotators (e.g.., Internal Medicine residents who are rotating through the Emergency Department).

Exclusion Criteria:

• Exclusion criteria include patients who are in cardiac arrest, or if the patient received any positive pressure ventilation (i.e, BPAP, CPAP, BVM) in the emergency department before RSI.

Related Conditions & MeSH terms

• Apnea
• Apneic Oxygenation
• Endotracheal Intubation

Intervention

Other:
• Apneic oxygenation during endotracheal intubation
Providing oxygenation through nasal cannula during the apneic phase of endotracheal intubation.

Locations

Country	Name	City	State
United States	University Hospital	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lowest oxygen saturation overall	Lowest oxygen saturation between overall control and intervention groups	Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation
Secondary	Lowest oxygen saturation precipitous intubations	Lowest oxygen saturation between control and intervention groups that did not receive adequate pre-oxygenation only	Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation
Secondary	Lowest oxygen saturation pre-oxygenation	Lowest oxygen saturation between control and intervention groups that did receive	Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation
Secondary	Difference in baseline and final oxygen saturation		Decision to intubate through 2 minutes after completion of endotracheal intubation
Secondary	Difference in oxygen saturation before and after apneic period		Initiation of neuromuscular blockade through 2 minutes after completion of endotracheal intubation
Secondary	Desaturation	The proportion of patients who desaturate below 90%	Initiation of neuromuscular blockade through 2 minutes after completion of endotracheal intubation
Secondary	number of attempts	number of times laryngoscope is placed into the mouth in an attempt to pass an endotracheal tube	From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes.
Secondary	Need for second operator	A second physician had to attempt intubation	From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes.
Secondary	Need for additional intubating equipment	The operator needed to change or add equipment to facilitate intubation	From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes.
Secondary	Esophageal intubations	The proportion of intubations that resulted in the endotracheal tube being placed in the esophagus	From first attempt at intubation through entire ED stay, approximately 6 hours.
Secondary	Procedural hypotension	Proportion of became hypotensive at any point during the intubation procedure	Initiation of neuromuscular blockade to 2 minutes after completion of endotracheal intubation
Secondary	Aspiration	Proportion of patients that had evidence of aspiration	Within 24 hours after intubation procedure was complete
Secondary	Hospital length of stay	Number of days patient is hospitalized	Up to 28 days after intubation
Secondary	Number of days intubated		Up to 28 days after intubation
Secondary	In-hospital mortality		Up to 28 days after intubation