Clinical trial NCT06751043: Preoperative Fasting Vs. Not Fasting in Critically Ill Patients
Official title: FEEDS Trial - Fasting Preprocedurally in Enteral Nutrition: Evaluation of Divergent Approaches in Secure Airway
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Critical Illness
Surgical Procedure, Unspecified
Pulmonary Aspiration
Fasting
Keywords: pulmonary aspiration
enteral nutrition
tube feeding
preoperative fasting
perioperative medicine
surgery in critically ill
procedures in critically ill
nutrition in critical illness
perioperative safety
preoperative management
preoperative fasting in secure airway
anesthesia in critically ill
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Columbia University
First posted: 2024-12-27
Enrollment: 1072
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase III pragmatic multicenter parallel-group randomized controlled non-inferiority trial with patient-level randomization and assessor blinding. If non-inferiority is demonstrated, we will perform a pre-specified superiority test.
Primary purpose: PREVENTION

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:

* 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.
* Be monitored via medical record for amount of protein and calories received, and any complications related to fasting/not fasting.
* Receive a phone call from the study team about 3 months after they enter the study to see how they are doing and complete a questionnaire.

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

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

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18
2. Current admission to ICU
3. Secure airway with no plans for its removal prior to procedure
4. Current non-trophic (\> 10 mL/hr) tube (enteral) feeding with no plans to discontinue prior to procedure for reasons other than preoperative fasting
5. Planned eligible procedure 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.)
   * Are NOT performed on the gastrointestinal tract or lung/airway.
   * 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.

Exclusion Criteria:

1. Inability to obtain informed consent
2. Inability to enroll and randomize \> 8 hours prior to planned procedure time
3. Inability to deliver trial interventions
4. Expected survival \< 48 hours as determined by the enrolling physician-investigator
5. Critically ill burn patient
6. Emergency procedure
7. Gastrointestinal tract or airway/lung procedure
8. Plan for prone or Trendelenburg (head down) positioning during the procedure
9. 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)
10. Plan for postoperative extubation in the procedure area
11. Prisoner
12. 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

Primary outcomes:
measure: Days alive and free from mechanical ventilation on postoperative day 28.
timeFrame: Post-operative day 28
Secondary outcomes:
measure: Postoperative mortality
timeFrame: Post-operative day 28
measure: Ventilator-free days in survivors
timeFrame: Post-operative day 28
measure: All-cause, all-location mortality
timeFrame: Post-operative day 90
measure: Length of ICU stay
timeFrame: Post-operative day 90
measure: Length of hospital stay
timeFrame: Post-operative day 90
measure: Days alive and without life support54 Days alive and without life support
timeFrame: Post-operative day 90
measure: Proportion of patients alive and at home
timeFrame: Post-operative day 90
measure: Health-related quality of life
timeFrame: Post-operative day 90
measure: New surgical site infection
timeFrame: Post-operative day 90
measure: New bacteremia
timeFrame: Post-operative day 90
measure: Perioperative pulmonary aspiration
timeFrame: Time of procedure start +/- 24 hours
measure: Perioperative Hyperglycemia
timeFrame: Time of procedure start +/- 24 hours
measure: Perioperative hypoglycemia
timeFrame: Time of procedure start +/- 24 hours
measure: Preoperative fasting duration
timeFrame: Time of procedure start - 72 hours
measure: Postoperative fasting duration
timeFrame: Time of procedure start + 72 hours
measure: Perioperative fasting duration
timeFrame: Time of procedure start +/- 72 hours
measure: Preoperative calories delivered
timeFrame: Time of procedure - 72 and -24 hours
measure: Postoperative calories delivered
timeFrame: Time of procedure + 72 and + 24 hours
measure: Perioperative calories delivered
timeFrame: Time of procedure +/- 72 and +/- 24 hours
measure: Preoperative protein delivered
timeFrame: Time of procedure - 72 and -24 hours
measure: Postoperative protein delivered
timeFrame: Time of procedure + 72 and + 24 hours
measure: Perioperative protein delivered
timeFrame: Time of procedure +/- 72 and +/- 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Alexander Nagrebetsky, MD, MSC
role: PRINCIPAL_INVESTIGATOR
References: