Status:
COMPLETED
Intermittent Versus Continuous Enteral Nutrition in Mechanically Ventilated Patients in the Medical Intensive Care Unit
Lead Sponsor:
Yale University
Conditions:
Enteral Feeding
Nutrition Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Evaluate effective delivery of goal nutrition with intermittent as compared with continuous enteral nutrition schedules, as defined by percentage of recommended calories that patient receives per day ...
Detailed Description
Eligible patients will be approached and if the patient (or surrogate decision maker) is interested, then consent will be obtained for participation in the study. The patient will then be randomly ass...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- MICU Yale New Haven Hospital
- Age \>= 18 years old.
- Patients mechanically ventilated via endotracheal tube
- Patients intubated within 72 hours of hospital admission
- First intubation of current hospitalization
- First MICU admission of current hospitalization
- EXCLUSION CRITERIA
- • Patient has opted out of research participation via institutional patient portal.
- At significant risk for gastrointestinal intolerance of intermittent bolus feeds:
- Prior upper gastrointestinal surgery that alters proximal GI anatomy (including but not limited to gastric bypass surgery, gastric banding, complete or partial gastrectomy, Whipple procedure; of note, appendectomy and cholecystectomy are not exclusion criteria.
- Structural gastrointestinal obstruction (such as tumor).
- Chronic enteral nutrition (prior to current admission).
- History of significant esophageal dysmotility (history of GERD is acceptable) or clinically significant GE junction incompetence
- Unable to have head of bed elevated at least 30 degrees while intubated and being fed (this is standard protocol).
- Enteral access terminates post-pyloric (ie nasojejunal or jejunostomy tubes are to be excluded) or unable to place gastric tube for access. (The clinical team will determine type of tube placement. As this is particularly selected by intensivists for patients at higher aspiration risk, this tube enteral access exclusion de facto excludes patients at high aspiration risk.)
- History of small bowel obstruction or ileus on current admission or within last 1 month.
- History of gastroparesis.
- Percutaneous gastrostomy tube or tracheostomy.
- History of ongoing aspiration as determined by a speech medicine specialist or other medical professional or a patent who required adjustment of diet (e.g., thickening of liquids) prior to hospitalization.
- History of significant esophageal dysmotility (history of GERD is acceptable) or clinically significant GE junction incompetence
- Other Exclusion Criteria:
- At risk of refeeding syndrome.
- Pregnant patients.
- Patients receiving neuromuscular blockade.
- Patients with glycemic emergency (HHNK, DKA, severe hypoglycemia resulting in MICU admission) or patients controlling their sugar / insulin dosing via continuous glucose monitoring
- Post cardiac arrest (on current admission).
- Received \>= 6 hours of enteral nutrition (regardless of volume) at the time of screening and team is able to consent / enroll / initiate intermittent feed within an additional 2 hours.
- Plan for extubation within 24 hours.
- Not English-speaking.
- Patients otherwise excluded by the treating physician.
- Retrospective exclusion: patients who initially met eligibility criteria, but no nutrition consult (i.e., decision to initiate feeds by clinical providers) placed within 72 hours of intubation.
Exclusion
Key Trial Info
Start Date :
July 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04437264
Start Date
July 7 2020
End Date
December 7 2022
Last Update
March 3 2025
Active Locations (1)
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1
Yale New Haven Hospital, York Street Campus
New Haven, Connecticut, United States, 06520