NutritionNCT04164108
Pilot: Feasibility of Intermittent Enteral Feeding in Ventilated MICU Patients
A study testing Intermittent Enteral Nutrition Protocol in people with Nutrition, run by Yale University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutrition
- What is being tested?
- Intermittent Enteral Nutrition Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Nov 2019to 18 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical intensive care unit patients located in Yale-New Haven Hospital, York Street campus, North Pavilion 9 or 10.
- Hospitalized for less than or equal to 72 hours.
- Patients who are mechanically ventilated via endotracheal tube for at least 24 hours.
- Patients must have enteral access (nasogastric tube, orogastric tube).
- Team plans to initiate tube feeds.
Who cannot join
- Prior upper gastrointestinal surgery (including but not limited to gastric bypass surgery, gastric banding, complete or partial gastrectomy, Whipple procedure; cholecystectomy is acceptable).
- Chronic enteral nutrition (prior to current admission).
- History of significant esophageal dysmotility (history of GERD is acceptable).
- 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).
- Pre-existing percutaneous gastrostomy tube.
Show all 14Show fewer
- History of small bowel obstruction or ileus on current admission.
- History of gastroparesis.
- Clinical care team is not planning to initiate enteral nutrition.
- At risk of refeeding syndrome.
- Pregnant patients.
- Patients receiving neuromuscular blockade.
- Patients with glycemic emergency (HHNK, DKA, severe hypoglycemia resulting in MICU admission).
- Patients otherwise excluded by the treating physician.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale New Haven Hospital
New Haven, Connecticut, 06510
Yale New Haven Hospital, York Street Campus
New Haven, Connecticut, 06520
About this study
Official title: Pilot Study to Assess the Feasibility and Safety of Intermittent Enteral Feeding in Mechanically Ventilated Medical Intensive Care Unit Patients
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.
Read the 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
- Being tested
- Intermittent Enteral Nutrition Protocol
- Keywords
- intensive care unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Enteral Nutrition ProtocolDietary supplement
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%.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent feed participants | Experimental | Patients admitted to medical ICU #1 (of 2 at our hospital) will be assigned to receive intermittent enteral feeding protocol. They will receive four equal volume feeds at 8:00, 12:00, 16:00, and 20:00 hours. Receives: Dietary Supplement: Intermittent Enteral Nutrition Protocol |
| Control participants | No intervention | Patients admitted to the medical ICU #2 (of 2 at our hospital) will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion complete protocol
This is defined as the proportion of patients who continue to receive intermittent enteral feeds during the entire course of their enteral nutrition or seven days, whichever comes first.
Measured: Up to 7 days
Secondary outcomes (17)
Proportion correct pump rate
This is defined as the proportion of the feeds that enteral feeding pump provides nutrition at appropriate rate.
Measured: Up to 7 days
Proportion clogged enteral access
This is defined as the proportion of patients whose enteral access is clogged.
Measured: Up to 7 days
Proportion completed meals
This is defined as the proportion of meals that are delivered.
Measured: Up to 7 days
Staff satisfaction
This will be measured using a qualitative survey of bedside nurses and ICU nutritionists regarding perceptions of intervention feasibility.
Measured: Up to 7 days
Proportion held to accommodate a medication
This is defined as the proportion of patients who had enteral nutrition held to accommodate a medication.
Measured: Up to 7 days
Proportion held to accommodate a procedure
This is defined as the proportion of patients who had enteral nutrition held to accommodate a procedure.
Measured: Up to 7 days
Early mobility
This is defined as the proportion of patients able to participate in early mobility.
Measured: Up to 7 days
Proportion feeding intolerance
This is defined as the proportion of patients with one or more of the following conditions:
- New onset nausea or vomiting
- Clinical concern for ileus or obstruction, as documented in progress notes
- New onset abdominal distension, as documented in progress notes
- Abdominal X-ray (not obtained for purposes of line/tube placement verification)
Measured: Up to 7 days
Proportion Diarrhea
This is defined as the proportion of patients with diarrhea.
Measured: Up to 7 days
Symptomatic elevated gastric residual volume
This is defined as the proportion of patients with gastric residual volume >500 AND any of the following symptoms:
- New onset nausea or vomiting
- Clinical concern for ileus or obstruction, as documented in progress notes
- New onset abdominal distension, as documented in progress notes
- Abdominal X-ray (not obtained for purposes of line/tube placement verification)
Measured: Up to 7 days
Percent of recommended nutrition delivered
This is defined as the average daily calorie intake as percentage of goal calories (determined by RD).
Measured: Up to 7 days
Nutrition delay
This is defined as the time (hours) from intubation to patient receiving 50% of caloric needs.
Measured: Up to 7 days
Adequate nutrition provision
This is defined as the proportion of days that patient is receiving enteral nutrition that at least 70% of caloric need is administered.
Measured: Up to 7 days
Inadequate nutrition provision
This is defined as the proportion of days that patient is receiving enteral nutrition that less than 30% of caloric need is administered.
Measured: Up to 7 days
Hyperglycemia proportion
This is defined as the proportion of glucose measurements closest to 8:00, 12:00, 16:00, 20:00 (including on basic metabolic panel and point of care testing) that are greater than or equal to 180.
Measured: Up to 7 days
Insulin drip usage
This is defined as the proportion of glucose measurements closest to 8:00, 12:00, 16:00, 20:00 (including on basic metabolic panel and point of care testing) that are less than or equal to 60.
Measured: Up to 7 days
Non-diabetic insulin usage proportion
This is defined as the proportion of patients who do not have a pre-existing diagnosis of diabetes mellitus who require any insulin dose.
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start18 Nov 2019
- Primary completion18 Mar 2020
- Study completion18 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shyoko Honiden, MD, Principal investigator, Program Director, Pulmonary & Critical Care Medicine Program, Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164108
- Sponsor's protocol ID
- IRB Exempt
- Status last verified
- May 2021
- First submitted
- 12 Nov 2019
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Feasibility and Safety of Intermittent Enteral Feeding in Mechanically Ventilated Medical Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT04164108
- Acronym / sponsor ID
- IRB Exempt
- Conditions
- Nutrition
- Keywords
- intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 18 Mar 2020 (actual)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent feed participants | Experimental | Dietary Supplement: Intermittent Enteral Nutrition ProtocolPatients admitted to medical ICU #1 (of 2 at our hospital) will be assigned to receive intermittent enteral feeding protocol. They will receive four equal volume feeds at 8:00, 12:00, 16:00, and 20:00 hours. |
| Control participants | No intervention | –Patients admitted to the medical ICU #2 (of 2 at our hospital) will receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Medical intensive care unit patients located in Yale-New Haven Hospital, York Street campus, North Pavilion 9 or 10.
- Hospitalized for less than or equal to 72 hours.
- Patients who are mechanically ventilated via endotracheal tube for at least 24 hours.
- Patients must have enteral access (nasogastric tube, orogastric tube).
- Team plans to initiate tube feeds.
Key exclusion criteria (14 listed)
- Prior upper gastrointestinal surgery (including but not limited to gastric bypass surgery, gastric banding, complete or partial gastrectomy, Whipple procedure; cholecystectomy is acceptable).
- Chronic enteral nutrition (prior to current admission).
- History of significant esophageal dysmotility (history of GERD is acceptable).
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent Enteral Nutrition ProtocolPatients 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%. | Dietary supplement | Intermittent feed participants |
Primary outcome
Proportion complete protocol
Time frame: Up to 7 days
This is defined as the proportion of patients who continue to receive intermittent enteral feeds during the entire course of their enteral nutrition or seven days, whichever comes first.
17 secondary outcomes
Proportion correct pump rate
Time frame: Up to 7 days
Proportion clogged enteral access
Time frame: Up to 7 days
Proportion completed meals
Time frame: Up to 7 days
Staff satisfaction
Time frame: Up to 7 days
Proportion held to accommodate a medication
Time frame: Up to 7 days
Proportion held to accommodate a procedure
Time frame: Up to 7 days
Early mobility
Time frame: Up to 7 days
Proportion feeding intolerance
Time frame: Up to 7 days
Proportion Diarrhea
Time frame: Up to 7 days
Symptomatic elevated gastric residual volume
Time frame: Up to 7 days
Percent of recommended nutrition delivered
Time frame: Up to 7 days
Nutrition delay
Time frame: Up to 7 days
Adequate nutrition provision
Time frame: Up to 7 days
Inadequate nutrition provision
Time frame: Up to 7 days
Hyperglycemia proportion
Time frame: Up to 7 days
Insulin drip usage
Time frame: Up to 7 days
Non-diabetic insulin usage proportion
Time frame: Up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shyoko Honiden, MD principal investigator
Program Director, Pulmonary & Critical Care Medicine Program, Internal Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Enteral Nutrition Protocol in people with Nutrition, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion complete protocol (time frame: Up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.