Preoperative Fasting vs. Not Fasting in Critically Ill Patients

Patient Population: Critically ill patients in the ICU who are: mechanically ventilated, receiving tube feeding (enteral nutrition), with a planned surgery or procedure. Up to 1072 subjects will be enrolled.

Phase III pragmatic multicenter parallel-group randomized controlled non-inferiority trial with patient-level randomization and assessor blinding.

Enrollment Period: Approximately two years.

Aims:

• Aim 1: To compare the risk of pulmonary complications and mortality from: (1) perioperative pulmonary aspiration6,33,34 due to not fasting vs. (2) systemic effects of nutritional loss18-24 due to preoperative fasting. We will quantify the risk of pulmonary complications and mortality as the number of postoperative days alive and free from mechanical ventilation (DAFV)35,36 in the target population of critically ill patients with a secure airway who undergo interventional procedures.
• Aim 2: To compare length of ICU and hospital stay, discharge to home, need for organ support, infectious complications, safety outcomes, and nutritional outcomes in tube-fed mechanically ventilated patients with a secure airway who are fasted vs. not fasted prior to procedure.
• Aim 3: To define the relationship between perioperative fasting duration, calorie/protein delivery, and clinical outcomes in mechanically ventilated patients who receive tube feeding.

Study participants will be randomized with a 1:1 allocation ratio to one of the following preprocedural interventions:

• Fasting - stopping tube feeding at least 8 hours prior to the scheduled procedure time;
• Not fasting - tube feeding until call for transfer to the procedure area.

Inclusion criteria

• 1. Age ≥ 18
• Current admission to ICU*
• Secure airway** with no plans for its removal prior to procedure
• Current non-trophic (> 10 mL/hr) tube (enteral) feeding*** with no plans to discontinue prior to procedure for reasons other than preoperative fasting
• Planned eligible procedure (Examples are listed in Appendix C) with anesthesia care or nursing sedation. Eligible procedures are defined as non-emergent diagnostic or therapeutic interventions that:

• Do NOT have a well-established practice of preoperative fasting. (For example, bedside placement of a vascular catheter [arterial, central venous, peripheral venous] by the ICU team is NOT eligible for this trial since it has a widely established practice of no preoperative fasting and is not generally scheduled for a specific time.)
• Do NOT require fasting for preoperative gastrointestinal tract preparation
• Do NOT require removal/replacement of the endotracheal or tracheostomy tube
• Do NOT require prone or Trendelenburg (head-down) positioning.
• Typically require procedural sedation or anesthesia care.
• Generally, are scheduled for a specific time (although this time can change, or procedure may be cancelled).
• Are performed in the operating room, non-operating room procedural areas, or at the patient's bedside.

• All ICU types are eligible: surgical, medical, cardiac, neurological, trauma, mixed etc.

• Secure airway is defined as a cuffed endotracheal tube or a cuffed tracheostomy tube.

• Patients with all types of feeding tubes are eligible, regardless of tube insertion site (nasal, oral, surgically implanted) and tube tip location (pre- and post-pyloric) †As determined by the enrolling physician-investigator

Exclusion criteria

• Inability to obtain informed consent
• Inability to enroll and randomize > 8 hours prior to planned procedure time
• Inability to deliver trial interventions
• Expected survival < 48 hours as determined by the enrolling physician-investigator
• Critically ill burn patient
• Emergency procedure
• a. Gastrointestinal tract procedure that requires fasting based on surgical indications or b. airway/lung procedure that requires removal of endotracheal or tracheostomy tube
• Plan for prone or Trendelenburg (head down) positioning during most of the procedure
• Major impairment of gastrointestinal motility or major structural disease of the gastrointestinal tract (e.g., severe gastroparesis, bowel obstruction, severe ileus, severely compromised lower esophageal sphincter, active gastrointestinal bleeding)
• Plan for postoperative extubation in the procedure area
• Prisoner
• Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test during the current hospitalization, or woman who is breast feeding
• Refusal to enroll patient by treating physician
• Extracorporeal Membrane Oxygenation (ECMO) at the time of potential enrollment, except patients scheduled for ECMO decannulation as the study procedure and patients expected to be off of ECMO at the time of study procedure.
• Chronic mechanical ventilation at pre-admission level of care