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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* 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.
'
Brief Title
Preoperative Fasting vs. Not Fasting in Critically Ill Patients
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.
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.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
617-724-3292
Central Contact Email
anagrebetsky@mgh.harvard.edu
Completion Date
Completion Date Type
Estimated
Conditions
Critical Illness
Surgical Procedure, Unspecified
Pulmonary Aspiration
Fasting
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
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
Inclusion 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.
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.
Gender
All
Gender Based
false
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
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06751043
Org Class
Other
Org Full Name
Massachusetts General Hospital
Org Study Id
2024P003035
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
FEEDS Trial - Fasting Preprocedurally in Enteral Nutrition: Evaluation of Divergent Approaches in Secure Airway
Primary Outcomes
Outcome Description
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.
Outcome Measure
Days alive and free from mechanical ventilation on postoperative day 28.
Outcome Time Frame
Post-operative day 28
Secondary Ids
Secondary Id
BPS-2023C1-31273
Secondary Outcomes
Outcome Description
Death from any cause at any location, including deaths after withdrawal of care.
Outcome Time Frame
Post-operative day 28
Outcome Measure
Postoperative mortality
Outcome Description
28 minus last post-operative day of mechanical ventilation assessed only in survivors at post-operative day 28. Non-survivors are excluded
Outcome Time Frame
Post-operative day 28
Outcome Measure
Ventilator-free days in survivors
Outcome Description
Death from any cause at any location, including deaths after withdrawal of care.
Outcome Time Frame
Post-operative day 90
Outcome Measure
All-cause, all-location mortality
Outcome Description
90 minus the last post-operative day of ICU admission.
Outcome Time Frame
Post-operative day 90
Outcome Measure
Length of ICU stay
Outcome Description
90 minus the last post-operative day of hospital/facility admission.
Outcome Time Frame
Post-operative day 90
Outcome Measure
Length of hospital stay
Outcome Description
90 minus the last post-operative day of mechanical ventilation, renal replacement therapy, or circulatory support (ECMO, vasopressor or inotrope), whichever is used last.
Outcome Time Frame
Post-operative day 90
Outcome Measure
Days alive and without life support54 Days alive and without life support
Outcome Description
Proportion of patients who are alive and at home or at pre-index hospitalization level of care.
Outcome Time Frame
Post-operative day 90
Outcome Measure
Proportion of patients alive and at home
Outcome Description
Short-Form 20
Outcome Time Frame
Post-operative day 90
Outcome Measure
Health-related quality of life
Outcome Description
Documentation of superficial incisional or organ/space infection after index procedure in routine medical records
Outcome Time Frame
Post-operative day 90
Outcome Measure
New surgical site infection
Outcome Description
Bacteremia in patients without pre-study intervention evidence of bacteremia during the same hospital admission.
Outcome Time Frame
Post-operative day 90
Outcome Measure
New bacteremia
Outcome Description
Periprocedural pulmonary aspiration of gastric contents documented in routine medical records.
Outcome Time Frame
Time of procedure start +/- 24 hours
Outcome Measure
Perioperative pulmonary aspiration
Outcome Description
Routinely collected blood glucose of \> 180 mg/dL on at least one measurement.
Outcome Time Frame
Time of procedure start +/- 24 hours
Outcome Measure
Perioperative Hyperglycemia
Outcome Description
At least one episode of routinely collected blood glucose of 41 to 70 mg/dL (moderate hypoglycemia) or ≤ 40 mg/dL (severe hypoglycemia).
Outcome Time Frame
Time of procedure start +/- 24 hours
Outcome Measure
Perioperative hypoglycemia
Outcome Description
Time from last routinely documented non-trophic (\> 10 mL/hr) tube feeding to procedure start.
Outcome Time Frame
Time of procedure start - 72 hours
Outcome Measure
Preoperative fasting duration
Outcome Description
Time from procedure end to the first routinely documented non-trophic (\>10 mL/hr) tube feeding volume/rate.
Outcome Time Frame
Time of procedure start + 72 hours
Outcome Measure
Postoperative fasting duration
Outcome Description
Duration of preoperative plus postoperative fasting.
Outcome Time Frame
Time of procedure start +/- 72 hours
Outcome Measure
Perioperative fasting duration
Outcome Description
Total number of calories delivered via tube feeding within 24 and 72 hours prior to procedure.
Outcome Time Frame
Time of procedure - 72 and -24 hours
Outcome Measure
Preoperative calories delivered
Outcome Description
Total number of calories delivered via tube feeding within 24 and 72 hours after the procedure.
Outcome Time Frame
Time of procedure + 72 and + 24 hours
Outcome Measure
Postoperative calories delivered
Outcome Description
Total number of calories delivered via tube feeding within 24 and 72 hours of the procedure.
Outcome Time Frame
Time of procedure +/- 72 and +/- 24 hours
Outcome Measure
Perioperative calories delivered
Outcome Description
Total amount of protein delivered via tube feeding within 24 and 72 hours prior to procedure.
Outcome Time Frame
Time of procedure - 72 and -24 hours
Outcome Measure
Preoperative protein delivered
Outcome Description
Total amount of protein delivered via tube feeding within 24 and 72 hours after the procedure.
Outcome Time Frame
Time of procedure + 72 and + 24 hours
Outcome Measure
Postoperative protein delivered
Outcome Description
Total amount of protein delivered via tube feeding within 24 and 72 hours of the procedure
Outcome Time Frame
Time of procedure +/- 72 and +/- 24 hours
Outcome Measure
Perioperative protein delivered
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Michael Kiyatkin
Investigator Email
mkiyatkin@montefiore.org
Investigator Department
Anesthesiology
Investigator Sponsor Organization
Montefiore
Study Department
Anesthesiology
Study Division
Please Specify
MeSH Terms
CRITICAL ILLNESS
FASTING
DISEASE ATTRIBUTES
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
FEEDING BEHAVIOR
BEHAVIOR
ANGPTL4 PROTEIN, MOUSE