An interventional study of Feeds continued and Feeds held in Tracheostomy Complication, Critical Illness and Nutritional Deficiency, sponsored by State University of New York at Buffalo. Recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-20.
Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Supportive care
The goal of this clinical trial is to evaluate nutrition administration in the time around the tracheostomy in patients with breathing tubes. The main questions it aims to answer are:
Researchers will compare patients who have nutrition withheld 6 hours prior to surgery versus those who receive nutrition up until the time of surgery to see if there are differences in food intake, instances of food entering the lungs or lung infections.
Malnutrition is a significant problem in the critically ill, however with busy operating room schedules, we often find that feeds are interrupted repetitively prior to elective surgery. These interruptions are practiced based on the American Society of Anesthesiologist guidelines for fasting intervals for elective surgery. These guidelines, however, were not created for critically ill, intubated patients. The theoretical concern for an increased risk of aspiration with continuation of enteral feeds up to the time of surgery persists without supporting evidence. Thus, there is a need for a universal evidence-based guideline on perioperative enteral feeding to benefit critical care patients.
To this end, the goal of the present study is to implement a protocol designed to decrease the interruption of enteral feeds in critical care patients undergoing tracheostomy and prospectively evaluate whether this leads to a quantitative increase in nutritional intake without increasing the risk of aspiration. Additionally, we hope that increasing quantitative nutrition may decrease morbidity especially in the small subset of patients where feed interruptions occur repetitively.
If the aims of the project are achieved, the data obtained from this study will be used to create an evidence-based platform from which physicians can practice. This will end the anecdotal controversy regarding perioperative tube feed management for tracheostomy; thereby increasing quantitative nutrition and hopefully improving the care of critically ill patients.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's planned enrollment of 200 is above the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →State University of New York at Buffalo is the lead sponsor of 287 studies on the registry; 65 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Enteral feeds are continued up until time of tracheostomy.
Other: Feeds continued
Enteral feeds are withheld at least 6 hours prior to time of tracheostomy.
Other: Feeds held
Enteral feeds are continued up until time of surgery
Enteral feeds are stopped 6 or more hours before surgery
Rate of aspiration pneumonia
To assess differences in rates of aspiration events, a log-rank test for differences in survival curves model will be used. Assuming proportional hazards and non-informative censoring, a cox-model will be used to estimate follow-up hazard ratios for development of aspiration pneumonia between the two groups of interest.
Time frame: Over 7 days from the time of tracheostomy
Volume of tube feed delivery
We will compare the volume of tube feeds delivered daily between the two groups for the duration of the study.
Time frame: From day of consent to completion of study which is 7 days from the time of tracheostomy.
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State University of New York at Buffalo