Vanderbilt University Medical Center
The INtubation with Sedation Only to Preserve Independent Respiratory Effort (INSPIRE) trial is a pragmatic, non-blinded, parallel-group, randomized clinical trial comparing the effect of intubation with sedation only (intervention group) versus intubation with sedation plus neuromuscular blockade (control group) among adults undergoing emergency tracheal intubation in the ED and ICU with regard to the outcomes of: (1) hypoxemia during intubation, (2) successful intubation on the first attempt, and (3) awake immobility and PTSD symptoms. Patients who are determined by treating clinicians to require emergency tracheal intubation and who meet eligibility criteria will be enrolled and randomly assigned to either intubation with sedation only or intubation with sedation plus neuromuscular blockade.
Each year more than 1.5 million critically ill patients undergo emergency tracheal intubation in the United States (US). Unlike intubation in an operating room (during which less than 1% of patients experience a serious complication), 20% of patients intubated in an emergency department (ED) or intensive care unit (ICU) experience hypoxemia, and 2.5% of patients experience a cardiac arrest. The most common approach to emergency tracheal intubation in current clinical care involves rapid administration of a sedative followed by a neuromuscular blocking agent (i.e. a paralytic). This technique…
Inclusion Criteria: 1. Patient is undergoing emergency tracheal intubation with the use of sedation in a participating unit 2. Clinician willing to use a video-laryngoscope for the intubation Exclusion Criteria: 1. Patient is known to be less than 18 years old 2. Patient is known to be pregnant 3. Patient is known to be a prisoner 4. Clinician has determined that use of a direct laryngoscope, bronchoscope, or an intubating laryngeal mask airway is required for the optimal care of the patient. 5. Patient or Legally Authorized Representative declines participation during pre-enrollment conver…
Patients in the sedation only group will undergo emergency tracheal intubation with sedation only (without receiving neuromuscular blockade) on the first attempt. The choice and dose of the sedative agent(s) (e.g., etomidate, ketamine, propofol, or other) will will be at the discretion of the operator and in accordance with usual clinical practice in the participating unit.
Patients in the sedation plus neuromuscular blockade group will receive sedation plus neuromuscular blockade prior to the first attempt at intubation. The choice and dose of the sedative agent(s)) (e.g., etomidate, ketamine, propofol, or other) and neuromuscular blockade agent(s) (e.g., succinylcholine, rocuronium, or other) will be at the discretion of the operator and in accordance with usual clinical practice in the participating unit.
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