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Trial of Continuous Versus Interrupted Feeding for Intubated Intensive Care Unit Patients

A Randomized Trial of Continuous Versus Interrupted Enteral Feeding in Critically Ill Surgical Patients Requiring Mechanical Ventilation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01383980
Enrollment
36
Registered
2011-06-28
Start date
2011-08-31
Completion date
2017-08-31
Last updated
2019-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition

Keywords

Enteral Nutrition, Enteral Feeding, nasogastric tubes, gastrostomy tubes, jejunostomy tubes

Brief summary

Surgical patients fed up until the point of surgery will have safe delivery of more calories compared to a group whose feeding is held at midnight prior to surgery.

Detailed description

Nutrition is essential for healing and recovery from illness. Tube feeds are the standard care for patients with prolonged stays in the intensive care unit (ICU) who cannot eat food on their own. Tube feeding means that a tube has been placed in a patient's stomach or small intestine to provide nutrition. When a patient is scheduled for an elective surgery, he/she usually has nothing to eat after midnight prior to the operation. A fasting period before surgery is done to avoid possible side effects during the placement of a breathing tube. Having an empty stomach is thought to decrease the chances of vomiting or aspiration while a breathing tube is placed. (Aspiration occurs when a substance, such as food provided by a tube feed, enters the airway.) However, some patients already have a breathing tube in place. The investigators do not know which is better for patients who already have a breathing tube in place: continuing feedings up until surgery or stopping them the night before. The investigators hypothesize intubated surgical patients randomized to a protocol of feeding up until the point of surgery will have the safe delivery of more calories as compared to a group whose feeding is held at midnight prior to surgery.

Interventions

DIETARY_SUPPLEMENTContinuous Tube Feedings

Tube feeds continued up until elective surgery.

Sponsors

Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Subjects are randomized to remain NPO at midnight prior to surgery or to continue to receive tube feeding up until surgery time.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Intubated with planned visit to the OR * Admitted to an ICU at OHSU * Receiving enteral nutrition or plan to start enteral nutrition

Exclusion criteria

* Age less than 18 years * Unable to obtain consent from patient or ARR

Design outcomes

Primary

MeasureTime frameDescription
Total calories deliveredDaily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant.The total number of calories subject consume while receiving tube feeding.

Secondary

MeasureTime frameDescription
Laboratory valuesDaily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant.Laboratory values of interest include: CBC, liver function tests, basic metabolic panel, magnesium, phosphate, alubmin, prealubumin, c-reactive protein, and arterial blood gas.
Weight changeDaily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant.The change of weight during hospital admission.
number of infections and aspiration eventsFrom date of randomization until the date of documented complication. Subjects will be followed until discharge in case of multiple complications. Date of discharge is estimated to be three (3) weeks post-admission on average.Number of infections or aspiration events during hospitalization

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026