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Apneic Oxygenation Including Precipitous Intubations During RSI in the ED (RAPID)

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ClinicalTrials.gov Identifier: NCT03694379
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Ilya Ostrovsky, MD, Rutgers, The State University of New Jersey

Brief 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.

Condition or disease Intervention/treatment Phase
Apneic Oxygenation Endotracheal Intubation Other: Apneic oxygenation during endotracheal intubation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 346 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Apneic Oxygenation Including Precipitous Intubations During RSI in the Emergency Department
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Arm Intervention/treatment
Experimental: Apneic Oxygenation
Participants receiving apneic oxygenation
Other: Apneic oxygenation during endotracheal intubation
Providing oxygenation through nasal cannula during the apneic phase of endotracheal intubation.

No Intervention: No Apneic Oxygenation
Participants not receiving apneic oxygenation



Primary Outcome Measures :
  1. Lowest oxygen saturation overall [ Time Frame: Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation ]
    Lowest oxygen saturation between overall control and intervention groups


Secondary Outcome Measures :
  1. Lowest oxygen saturation precipitous intubations [ Time Frame: Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation ]
    Lowest oxygen saturation between control and intervention groups that did not receive adequate pre-oxygenation only

  2. Lowest oxygen saturation pre-oxygenation [ Time Frame: Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation ]
    Lowest oxygen saturation between control and intervention groups that did receive

  3. Difference in baseline and final oxygen saturation [ Time Frame: Decision to intubate through 2 minutes after completion of endotracheal intubation ]
  4. Difference in oxygen saturation before and after apneic period [ Time Frame: Initiation of neuromuscular blockade through 2 minutes after completion of endotracheal intubation ]
  5. Desaturation [ Time Frame: Initiation of neuromuscular blockade through 2 minutes after completion of endotracheal intubation ]
    The proportion of patients who desaturate below 90%

  6. number of attempts [ Time Frame: From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes. ]
    number of times laryngoscope is placed into the mouth in an attempt to pass an endotracheal tube

  7. Need for second operator [ Time Frame: From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes. ]
    A second physician had to attempt intubation

  8. Need for additional intubating equipment [ Time Frame: From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes. ]
    The operator needed to change or add equipment to facilitate intubation

  9. Esophageal intubations [ Time Frame: From first attempt at intubation through entire ED stay, approximately 6 hours. ]
    The proportion of intubations that resulted in the endotracheal tube being placed in the esophagus

  10. Procedural hypotension [ Time Frame: Initiation of neuromuscular blockade to 2 minutes after completion of endotracheal intubation ]
    Proportion of became hypotensive at any point during the intubation procedure

  11. Aspiration [ Time Frame: Within 24 hours after intubation procedure was complete ]
    Proportion of patients that had evidence of aspiration

  12. Hospital length of stay [ Time Frame: Up to 28 days after intubation ]
    Number of days patient is hospitalized

  13. Number of days intubated [ Time Frame: Up to 28 days after intubation ]
  14. In-hospital mortality [ Time Frame: Up to 28 days after intubation ]


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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:

  • 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.

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): NCT03694379


Contacts
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Contact: Ilya Ostrovsky, MD 9739721428 ostrovil@njms.rutgers.edu
Contact: Andreia B Alexander, MD, PhD 8123910399 abalexan@iu.edu

Locations
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United States, New Jersey
University Hospital Recruiting
Newark, New Jersey, United States, 07103
Contact: Gregory Sugalski, MD         
Sub-Investigator: Andreia B Alexander, MD, PHD         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
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Principal Investigator: Ilya Ostrovsky, MD Rutgers, The State University of New Jersey

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Responsible Party: Ilya Ostrovsky, MD, Assistant Professor of Emergency Medicine, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03694379     History of Changes
Other Study ID Numbers: Pro2018000579
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ilya Ostrovsky, MD, Rutgers, The State University of New Jersey:
Apneic Oxygenation
Endotracheal intubation
Airway Management
Emergency Department

Additional relevant MeSH terms:
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Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms