Intubation with Sedation Only to Prevent Hypoxemia during Emergency Tracheal Intubation of Critically Ill Adults: A Randomized Clinical Trial

Dr. Stephanie DeMasi is an academic physician-scientist in the Department of Emergency Medicine at Vanderbilt University Medical Center. Her focus is improving care for patients receiving time-sensitive interventions in the emergency department (ED) and intensive care unit (ICU). To achieve her long-term career goal of becoming an expert acute care clinical trialist, her career development goals are to [1] learn rigorous pragmatic randomized trial design, [2] become an expert in exception from informed consent (EFIC), waiver, and written informed consent processes, [3] develop expertise in the collection and analysis of long-term functional and psychological outcomes after critical illness, and [4] build leadership skills to effectively lead multicenter randomized trials. Research Proposal Summary: Each year in the United States, millions of adults undergo emergency tracheal intubation (placement of a breathing tube). Nearly one quarter of patients undergoing tracheal intubation in an ED or ICU experience hypoxemia, which more than doubles the risk of death. The most common approach to intubation of critically ill adults involves the administration of a sedative followed by neuromuscular blockade (paralysis). The alternative approach of using only sedation for intubation has not been widely used historically because neuromuscular blockade was often needed for the person doing the intubation to see the vocal cords. In the current era, with video laryngoscopy and other advanced techniques, the patient’s muscles do not need to be as relaxed for the vocal cords to be easily visible on the video screen. Therefore, patients may not need to be paralyzed during intubation to achieve adequate visualization of the vocal cords. Avoiding neuromuscular blockade would allow patients to breathe spontaneously during intubation, potentially preventing hypoxemia. No randomized trial has ever compared tracheal intubation using only sedation vs using sedation and neuromuscular blockade among critically ill adults. This career development award application proposes to leverage our group’s research infrastructure to conduct the INtubation with Sedation Only to Preserve Independent Respiratory Effort (INSPIRE) trial, a single- center pragmatic randomized trial comparing the effect of emergency intubation using sedation only versus sedation plus neuromuscular blockade among 228 critically ill adults undergoing emergency intubation on the incidence of hypoxemia (Aim 1a), failure to intubate on the first attempt (Aim 1b), incidence of awake immobility (Aim 2a), and symptoms of PTSD at 90 days (Aim 2b). This application proposes a career development program that will (1) examine a fundamental treatment received by adults with acute respiratory failure, (2) provide the mentored learning for Dr. DeMasi to become a leader in the design and conduct of randomized trials in emergency care, and (3) ideally position Dr. DeMasi to lead subsequent multicenter trials of emergency interventions to improve care and outcomes of critically ill adults going forward. Project Number: 1K23HL181100-01 | Fiscal Year: 2025 | NIH Institute/Center: National Heart Lung and Blood Institute (NHLBI) | Principal Investigator: Stephanie DeMasi | Institution: VANDERBILT UNIVERSITY MEDICAL CENTER, NASHVILLE, TN | Award Amount: $185,720 | Activity Code: K23 | Study Section: NHLBI Mentored Patient-Oriented Research Study Section[MPOR (MA)] View on NIH RePORTER: https://reporter.nih.gov/project-details/1K23HL18110001