NCT04164108

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

November 18, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2020

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

4 months

First QC Date

November 12, 2019

Last Update Submit

May 24, 2021

Conditions

Nutrition

Keywords

intensive care unit

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 7 days

Secondary Outcomes (17)

  • Proportion correct pump rate

    Up to 7 days

  • Proportion clogged enteral access

    Up to 7 days

  • Proportion completed meals

    Up to 7 days

  • Staff satisfaction

    Up to 7 days

  • Proportion held to accommodate a medication

    Up to 7 days

  • +12 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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%.

Intermittent feed participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Yale New Haven Hospital, York Street Campus

New Haven, Connecticut, 06520, United States

Location

Study Officials

  • Shyoko Honiden, MD

    Program Director, Pulmonary & Critical Care Medicine Program, Internal Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2019

First Posted

November 15, 2019

Study Start

November 18, 2019

Primary Completion

March 18, 2020

Study Completion

March 18, 2020

Last Updated

May 25, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)