A Funding Odyssey: From ICU Fasting Frustrations to a Multicenter Clinical Trial

Archana Bharadwaj, MD, MPH, CHES

The process of designing a multicenter clinical trial can be both serendipitous and circuitous. A clinical question with an unclear answer can blossom into an opportunity for institutional collaboration, multiple publications, and larger research endeavors. In this Scholars’ Day panel, “Getting Your First Clinical Trial Funded – The Experience and Perspectives of Early-Career Investigators,” held Saturday, March 22, at the 2025 Annual Meeting, presented by IARS and SOCCA, the presenters discussed the evolution of the clinical challenge of managing preoperative fasting in critically ill patients into a multicenter clinical trial funded by PCORI.

Jamie Sparling, MD, an assistant professor of Anaesthesia at Harvard Medical School, launched the panel with her talk, “From Hospital Policy Dilemma to Research Hypothesis.” As an ICU clinician, she struggled with holding tube feeds for intubated patients for possible operating room procedures, which often resulted in prolonged periods of fasting for patients in particular need of continued nutrition for recovery. Guidelines from the American Society of Anesthesiologists (ASA) were limited on setting up enteral tube feeds. Additionally, the few articles in PubMed made it difficult to draw conclusions of clinical outcomes. This led to an exploration of work done at other large tertiary and quaternary referral centers and ultimately the development and implementation of a tube feed fasting policy in conjunction with colleagues in anesthesia, nutrition, surgery, and critical care. Patients were stratified based on the presence or absence of a secure airway, type of feeding tube, type of surgery, and surgical position. This policy helped nutrient delivery but was limited in scope. In turn, this blossomed into a survey-based study in collaboration with Ying Hui Low, MD and a multicenter clinical trial led by Alexander Nagrebetsky, MD, MSc, exploring the safety and efficacy of adopting less preoperative restrictive fasting policies.

The next speaker Ying Hui Low, MD, an associate professor of Anesthesiology at Dartmouth School of Medicine, focused on the survey portion of the project. She emphasized the value of surveys in gathering preliminary data and generating a hypothesis, in the absence of robust clinical data. For delivery platforms, there are a multitude that can be utilized, including REDCap and Qualtrics. In designing questions, Likert scale and yes/no question types can be used, but the data analysis plans need to reflect the type of questions utilized. To optimize response rate, researchers should consider the effects of survey fatigue and rewarding participation. For this study, the researchers focused their sample on department chairs, as they were most likely to be in tune with institutional policies.

Alexander Nagrebetsky, MD, MSc, an assistant professor of Anaesthesia at Harvard Medical School, rounded out the panel with his presentation, “Leveraging Professional Societies and Networks.” His presentation focused on the value of professional societies and practice guidelines to build expertise, an essential aspect of building the case for funding. In conjunction, practice guidelines and surveys can also boost publications. For the tube feeding project, the survey results discussed by Dr. Low illustrated division on managing preoperative fasting, which demonstrated a need for clear guidelines. This spurred the development of a task force within the ASA critical care medicine community. The task force put together recommendations on preprocedural fasting in hospitalized patients who receive tube feeding. The work in turn was utilized to emphasize expertise on the topic and was reflected in letters of support for the successful grant.