NCT04164108

Pilot: Feasibility of Intermittent Enteral Feeding in Ventilated MICU Patients

Pilot Study to Assess the Feasibility and Safety of Intermittent Enteral Feeding in Mechanically Ventilated Medical Intensive Care Unit Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Specific Aims: Aim 1: Evaluate the feasibility of intermittent feeding in intensive care unit patients who are mechanically ventilated. Aim 2: Evaluate the safety and patient tolerance of intermittent feeding in intensive care unit patients who are mechanically ventilated. Aim 3: Determine efficacy of intermittent feeding in provision of required nutrition in mechanically ventilated intensive care unit patients. Aim 4: Determine association of intermittent enteral feeding with glycemic control in mechanically ventilated intensive care unit patients.

Detailed description

With the advent of the feeding pump, default enteral nutrition schedules in many medical intensive care units has shifted from intermittent or bolus feeding to continuous feeds. Clinical studies suggest that each of these strategies of providing nutrition is safe for patients with no significant difference in glycemic control or adverse effects. There is also data to suggest that approximating a more physiologic nutrition schedule with periods of feeding and periods of fasting may optimize gastrointestinal and metabolic hormonal feedback loops thereby effecting outcomes such as gastrointestinal motility, protein synthesis, and glycemic control, among others. Circadian rhythm research supports a temporally restricted period of feeding as well. Furthermore, periods of scheduled fasting will allow for provision of care that is incompatible with enteral feeds, without interrupting administration of nutrition (for example, procedures or testing, incompatible medications, etc). Aims 1 and 2 will clarify whether an intermittent enteral nutrition schedule is acceptable to ICU staff and patients. Aims 3 and 4 will test whether this enteral feeding schedule is effective in providing patients with required nutrition and acceptable glycemic control. This pilot will set the stage for a randomized controlled trial further investigating superiority of intermittent feeding as compared with the current standard of continuous feeding.

Conditions

• Nutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Intermittent Enteral Nutrition Protocol	Patients will receive total recommended nutrition divided into four equal meals, delivered at a rate of 400 cc/hr at 8:00, 12:00, 16:00, 20:00. Titration schedule will include administering 50% of volume for first two feeds, then 75%, and then 100%.

Timeline

• Start date: 2019-11-18
• Primary completion: 2020-03-18
• Completion: 2020-03-18
• First posted: 2019-11-15
• Last updated: 2021-05-25

Locations

2 sites across 1 country: United States