In 2022, critical care and emergency medicine teams across Montefiore Medical Center performed 2,455 intubations , a procedure provided to patients experiencing extreme difficulty breathing on their own. “It’s by nature dangerous,” explains Daniel Fein, MD, associate professor in the division of pulmonology, director of inpatient pulmonary services for Montefiore Medical Center, and director of the medical and surgical intensive care unit at Montefiore Wakefield. “There is a high risk of cardiac arrest—where a patient’s heart stops beating effectively. An important cause of the heart stopping is if a patient’s oxygen level drops as we’re placing the breathing tube.”
Dr. Fein is the primary investigator at Montefiore Einstein in a major clinical trial evaluating strategies to reduce the chances of hypoxemia, or low oxygen, during intubation. Montefiore Einstein was one of 24 sites across the country that participated in the PREOXI trial, which stands for “Pragmatic Trial Examining Oxygenation Prior to Intubation,” and was sponsored by the U.S. Department of Defense. The results were recently published in the New England Journal of Medicine.
Patients in communities like the Bronx don’t always have access to high-impact clinical trials like the PREOXI study, which have the potential to change standards of care. Yet it’s critical that such research includes participants from a wide range of demographics. And it is core to Montefiore Einstein’s mission that our patients have access to the best evidence-based methods of care, including the types of promising new treatments that are the subjects of clinical trials.
Montefiore Einstein’s Bronx Center for Critical Care Outcomes and Resuscitation Research, or BCCORe, is helping ensure our patients are included in clinical trial research in critical care. The multidisciplinary BCCORe team participates in a number of clinical trial consortiums as well as pharmaceutical-sponsored studies, and research initiated here at our institution. BCCORe’s efforts resulted in over 40 published manuscripts last year.
“Our goal is to develop knowledge and evidence that is broadly applicable, but is also vital for our community,” says Dr. Fein. “We feel it’s important to be bringing clinical trials and observational research to the Bronx, whose residents wouldn’t otherwise benefit from this work.”
The PREOXI trial evaluated the use of positive-pressure oxygen, provided through the same type of mask used to prevent sleep apnea, to prevent hypoxemia following intubation. “Doctors have debated for a while about how to prevent drops in oxygen, and it's been determined that one of the best ways is to give oxygen before the procedure, which creates a reservoir. The PREOXI trial looked at how to do that the most effectively,” explains Dr. Fein.
Our goal is to develop knowledge and evidence that is broadly applicable, but is also vital for our community. We feel it’s important to be bringing clinical trials and observational research to the Bronx, whose residents wouldn’t otherwise benefit from this work.
Daniel Fein, MD, associate professor, division of pulmonology; director of inpatient pulmonary services, Montefiore Medical Center; and director of the medical and surgical intensive care unit, Montefiore Wakefield
The results found that using a tight-fitting non-invasive ventilation mask reduced the risk of hypoxemia by 10 percent versus a regular, non-pressurized oxygen mask. “This is quite significant in the scheme of medical research,” says Dr. Fein. “We do a lot of emergency intubations at Montefiore across our emergency rooms, ICUs, and our hospital floors.” Out of the 2,455 emergency intubations performed in 2022, roughly 260 experienced hypoxemia. Based on this, using a non-invasive ventilation mask could have improved outcomes in 26 patients. “We think these implementing these findings will really have a positive impact on patient care,” says Dr. Fein.
Of the 1,301 patients who were enrolled in the study, 103 were patients at Montefiore. Byline coauthors include Ari Moskowitz, MD, MPH; Luke Andrea, MD; Amira Mohammed, MD; Veronika Blinder, DO; and Rishi Malhotra, MD. A much larger team contributed to the study at Montefiore Einstein, including Samuel Rednor, DO, who enrolled the highest number of patients, at 13. (Scroll down for the full list of physicians and staff who were involved.)
Making a difference at critical moments
Clinical research in critical care focuses on a number of life-threatening conditions, according to Dr. Fein and Dr. Moskowitz, associate professor in the division of critical care and another member of the BCCORe team. These include sepsis and septic shock, severe lung injury and lung failure, broadly categorized as acute respiratory distress syndrome (ARDS), cardiac arrest, and infectious diseases resulting in critical illness including COVID, flu, and emerging pathogens. Quality improvement in the delivery of ICU care is an additional area of study.
Another recent multi-site study conducted by BCCORe, results of which were published in the Journal of the American Medical Association (JAMA), examined the effects of intravenous acetaminophen in sepsis patients. “Acetaminophen for Prevention and Treatment of Organ Dysfunction in Critically Ill Patients with Sepsis,” dubbed the ASTER trial, was led at Montefiore Einstein by Dr. Moskowitz. “The focus was on looking at Tylenol's antioxidant properties,” he says.
While the trial didn’t find that acetaminophen reduced mortality in patients experiencing septic shock, it did show benefits for the respiratory and coagulation systems. “Your body is always forming and breaking down blood clots,” explains Dr. Moskowitz. “In sepsis, that system goes haywire, so you have areas of your body that are having clots where they shouldn't have, and areas that are bleeding when they shouldn't. Tylenol seems to tamp down some of that disarray.” He continues, “This was a trial that's probably going to set up future trials in this space to dig further into those positive findings.”
Research assistants Ofelia Garcia, Martha Torres, and Elizabeth Nelson, and administrator Daniel Ceusters, celebrate enrolling the final patient in the PREOXI trial.
BCCORe is led by director Michelle Gong, MD, MS, chief of the divisions of pulmonary and critical care medicine. In addition to Dr. Fein and Dr. Moskowitz, physician members include Luke Andrea, MD, Amira Mohammed, MD, Lewis Eisen, MD, and Heyi Li, MD. There are also research assistants, data analysts, pharmacists, and chief administrator Daniel Ceusters. The BCCORe team currently has more than seven actively enrolling prospective studies and clinical trials, with several more in the pipeline and others, like the PREOXI and ASTER trials, that have recently wrapped up.
Drs. Moskowitz and Andrea were recently awarded a grant from the American Heart Association under its Get with the Guidelines Research Awards program, for a project titled “Survival after Cardiac Arrest Resuscitation: An Exploration of Outcome Variation and Social Determinants of Health.” Other current studies initiated at Montefiore Einstein include the Hospital Airway Resuscitation Trial, which compares two different advanced airway strategies for cardiac arrest, led by Dr. Moskowitz, and the Discover In-Hospital Cardiac Arrest study, a multicenter observational cohort study of post-cardiac arrest care, led by Dr. Andrea.
“BCCORe was established with the mission to enhance the care provided to our most critically ill patients by integrating scientific research into patient care,” says Dr. Gong. “This is a prime example of a Learning Healthcare System. Our commitment to improving patient care inspires and motivates our research, which in turn directly informs our clinical practices.”
She continues, “Conducting these scientific studies within our Bronx community is crucial to ensure the research addresses the specific needs of our patients, and that they benefit from the advances in care.”
*PREOXI Study Collaborators at Montefiore Einstein: Gerardo Eman, MD; Aron Soleiman, MD; Alban Cela, MD; Liza Leuallen, RRT; Deniz Muttalip, RRT; O'nieka Willie, RRT; Gabriella Roa Gomez, MD; Maneesha Bangar, MD; Ariel L Shiloh, MD; Deborah Orsi, MD; Lewis A. Eisen, MD; Ali A. Naqvi, MD; Michelle Gong, MD, MS; Sean P. McGrath, MD; Ibrahim Migdady, MD; Sachin Batra, MD; Amy Suhotliv, MD; Melanie Betchen, MD; Christian Lopez-Padilla, MD; Alexander M Petti, MD; Rithvik Balakrishnan, MD; Martin Hoang, MD; Kyle Foster, MD; Mahmoud Abdallah, DO; Meagan Murphy, MD; Zheng Lan, MD; David Brual, MD; Luis Grau Caro, MD; Sabah Boujid; Elizabeth Nelson; Maykl Mosheyev, MD; Tito Zerpa, MD; Nicole Patrice, BS, RRT; Jason Davis, RRT; Sarah Sungurlu, DO; Heyi Li, MD; Marjan Islam, MD; Rivkah Darabaner, MD; Mahmoud Y. Abdallah, DO; Ajay Puri, MD; Renata Lerner, MD, PhD; Hassan Hashm, MD; Vijai Bhola, MD; Rosemary Matossian, MD; Alberto Pinsino, MD; Pranav Sharma, MD; Ankit Kushwaha, MD; Brenda Lopez; Eugene Lekhner, PA; Jennifer Reynolds, RRT; Josefina Macauba, RRT; Samuel J Rednor, DO; Kevin S. Grewal, MD; Matthew Levitus, MD; Manoj L Karwa, MD; Timothy Tong, MD; Eric Miller, MD; Raymond Hou, MD; Abhishek Methukupally, MD; Ankita Krishnan, MD; James Murphy, MD; Maria Coluccio, MD; Tahmina Jahir, MD; Ryan Fiter, MD; Aman Shaikh, MD; Anshuman Sarangi, MD; Daniel Ceusters; Martha Torres; Ofelia Garcia.
Posted on: Thursday, June 27, 2024