Comparing Fasting and Not Fasting Before Procedures in Critically Ill Patients Receiving Tube Feeding

What this Trial Is About

Researchers are evaluating whether fasting or not fasting before a procedure affects recovery in critically ill patients who are on a breathing machine and receiving tube feeding. This trial aims to compare risks like lung complications and death, recovery times, hospital stays, infection rates, need for organ support, safety, and nutrition outcomes between those who fast and those who do not before a procedure. It also seeks to understand the relationship between nutrition and clinical outcomes in this patient group. Participants are randomly assigned to one of two groups the fasting group, which stops tube feeding at least 8 hours before the procedure, and the not fasting group, which continues tube feeding until transfer to the procedure area. This Phase III pragmatic multicenter trial uses patient-level randomization and assessor blinding. The study will enroll up to 1072 critically ill patients in the ICU who are mechanically ventilated and receiving tube feeding, all undergoing planned surgeries or procedures. During the study, participants are monitored through medical records for protein and calorie intake and any complications related to fasting or not fasting. Researchers will review routine electronic medical records for up to 3 months after the procedure to assess outcomes such as days alive and free from mechanical ventilation, mortality, ICU and hospital stay lengths, infections, organ support need, and nutritional delivery. The total participation duration includes enrollment, intervention, and follow-up until 3 months post-procedure.

Preoperative Fasting vs. Not Fasting in Critically Ill Patients