FEEDS Trial - Fasting Preprocedurally in Enteral Nutrition: Evaluation of Divergent Approaches in Secure Airway
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,072
- Locations
- 19
- Primary Endpoint
- Days alive and free from mechanical ventilation on postoperative day 28.
Study Overview
Brief Summary
The goal of this clinical trial is to learn if fasting or not fasting before a procedure has an effect on recovery in those who are critically ill. The main questions it aims to answer for patients on a breathing machine who are receiving tube feeding are:
- Does the risk of lung complications and death differ between those who are not fasting, which may have a higher chance of allowing tube feeding to enter the lungs, and fasting, which temporarily stops nutrition before a procedure?
- Is there a difference in recovery times, hospital stays, infection rates, need for organ support, safety, and nutrition for those who either fast or do not fast before a procedure?
- What is the relationship between nutrition and clinical outcomes?
Researchers will compare not fasting and fasting to see if it has an effect on recovery.
Participants will:
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Be assigned by chance (like a coin toss) to one of two groups. One group (fasting group) will have their tube feeding stopped at least 8 hours before their procedure. The other group (not fasting group) will have their tube feeding stopped right before their procedure.
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Be monitored via medical record for amount of protein and calories received, and any complications related to fasting/not fasting.
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Data from routine electronic medical records will be reviewed to determine how participants are doing 3 months after their procedure.
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Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Fasting
Patients randomized to the Fasting arm will have tube feeding stopped at least 8 hours before the scheduled surgery or procedure time.
Intervention: Fasting (Other)
Not Fasting
Patients randomized to the Not Fasting arm will have tube feeding continued until transfer to the operating room/procedure area.
Intervention: Not fasting (Other)
Outcomes
Primary Outcomes
Days alive and free from mechanical ventilation on postoperative day 28.
Time Frame: Post-operative day 28
Defined as the days alive and free of organ support (dialysis, assisted ventilation, and vasopressors) to day 28. Participants will need to be free of all three components (assisted ventilation, vasopressors, new renal replacement therapy) to qualify for a day alive and free from organ failures. Patients on chronic dialysis will not be scored for the new renal failure free component of this outcome.
Secondary Outcomes
- Postoperative mortality(Post-operative day 28)
- Ventilator-free days in survivors(Post-operative day 28)
- All-cause, all-location mortality(Post-operative day 90)
- Length of ICU stay(Post-operative day 90)
- Length of hospital stay(Post-operative day 90)
- Days alive and without life support54 Days alive and without life support(Post-operative day 90)
- Proportion of patients alive and at home(Post-operative day 90)
- Health-related quality of life(Post-operative day 90)
- New surgical site infection(Post-operative day 90)
- New bacteremia(Post-operative day 90)
- Perioperative pulmonary aspiration(Time of procedure start +/- 24 hours)
- Perioperative Hyperglycemia(Time of procedure start +/- 24 hours)
- Perioperative hypoglycemia(Time of procedure start +/- 24 hours)
- Preoperative fasting duration(Time of procedure start - 72 hours)
- Postoperative fasting duration(Time of procedure start + 72 hours)
- Perioperative fasting duration(Time of procedure start +/- 72 hours)
- Preoperative calories delivered(Time of procedure - 72 and -24 hours)
- Postoperative calories delivered(Time of procedure + 72 and + 24 hours)
- Perioperative calories delivered(Time of procedure +/- 72 and +/- 24 hours)
- Preoperative protein delivered(Time of procedure - 72 and -24 hours)
- Postoperative protein delivered(Time of procedure + 72 and + 24 hours)
- Perioperative protein delivered(Time of procedure +/- 72 and +/- 24 hours)
Investigators
Alexander Nagrebetsky, MD MSc
Anesthesia Attending
Massachusetts General Hospital