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

Not Applicable

Completed

• Conditions: Malnutrition
• Interventions: Dietary Supplement: Continuous Tube Feedings

• Registration Number: NCT01383980
• Lead Sponsor: Oregon Health and Science University

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.

Study Timeline

• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Study Start: 2011-08
• Primary Completion: 2015-08
• Study Completion: 2017-08
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-15
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Feeding	Continuous Tube Feedings	Tube feeds are continued up until surgery. Subjects with a nasogastric tube will have their stomach contents emptied prior to surgery.

Primary Outcome Measures

Name	Time	Method
Total calories delivered	Daily 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 Outcome Measures

Name	Time	Method
Laboratory values	Daily 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 change	Daily 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 events	From 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

Trial Locations

Locations (1)

Oregon Health & Science University (OHSU); 🇺🇸 Portland, Oregon, United States