200 Participants Needed

Continuous Enteral Feeding for Tracheostomy Care

Recruiting at 4 trial locations
EN
Overseen ByEden Nohra, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: State University of New York at Buffalo
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on nutrition around the time of tracheostomy surgery.

What data supports the effectiveness of the treatment Continuous Enteral Feeding for Tracheostomy Care?

Research shows that continuous enteral feeding helps critically ill patients meet their nutrition goals more effectively than intermittent feeding, which can be important for recovery. Additionally, avoiding fasting before procedures may prevent delays and improve overall nutrition intake.12345

Is continuous enteral feeding generally safe for humans?

Continuous enteral feeding is generally considered safe for humans. Studies have shown it is well tolerated with a low incidence of side effects, such as nausea and vomiting, and it can be a safe alternative to fasting in certain medical situations.15678

How is the treatment 'Continuous Enteral Feeding for Tracheostomy Care' different from other treatments?

This treatment is unique because it involves continuous feeding through a tube directly into the stomach or intestines, which is different from traditional methods that often require fasting before procedures. Continuous enteral feeding helps maintain consistent nutrition and reduces the risk of underfeeding, which can lead to worse outcomes in critically ill patients.59101112

What is the purpose of this trial?

The goal of this clinical trial is to evaluate nutrition administration in the time around the tracheostomy in patients with breathing tubes. The main questions it aims to answer are:* Will continuing nutrition up to the time of surgery (tracheostomy) decrease nutrition interruptions, thereby increasing food intake?* Does continuing nutrition up to the time of surgery increase instances of food going into the lungs or lung infections?Researchers will compare patients who have nutrition withheld 6 hours prior to surgery versus those who receive nutrition up until the time of surgery to see if there are differences in food intake, instances of food entering the lungs or lung infections.

Research Team

MJ

Marcy Jordan, PhD

Principal Investigator

University at Buffalo

Eligibility Criteria

This trial is for adults over 18 in the ICU who are intubated and need a tracheostomy. It's not for those under 18, unable to consent, on comfort measures or deemed brain dead within a week of enrollment, pregnant women, or prisoners.

Inclusion Criteria

I am currently in the Intensive Care Unit.
I am on a breathing machine and need surgery to help me breathe.

Exclusion Criteria

Unable to obtain informed consent
I have switched to comfort care within the last week.
Deemed clinically brain dead within 7 days of enrollment
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are assigned to either continue or withhold enteral feeds up until the time of tracheostomy

7 days
Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on aspiration pneumonia and nutritional intake

7 days

Treatment Details

Interventions

  • Feeds continued
  • Feeds held
Trial Overview The study compares two approaches: one where patients continue receiving nutrition right up until tracheostomy surgery versus another where feeds are stopped six hours before. The aim is to see if this affects food intake and lung complications.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Feeds withheldExperimental Treatment1 Intervention
Enteral feeds are withheld at least 6 hours prior to time of tracheostomy.
Group II: Feeds continuedExperimental Treatment1 Intervention
Enteral feeds are continued up until time of tracheostomy.

Find a Clinic Near You

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials
279
Recruited
52,600+

Findings from Research

This study is testing whether continuous enteral nutrition until extubation is a safe alternative to fasting for critically ill patients in the ICU, potentially reducing extubation failure rates and nursing workload.
The trial involves adult patients who have been ventilated for over 48 hours and will compare outcomes between those receiving ongoing nutrition and those undergoing a 6-hour fasting period before extubation, with the primary focus on the rate of reintubation within 7 days.
Continuous enteral nutrition compared with a maximal gastric vacuity strategy at the time of extubation in the intensive care unit: protocol for a non-inferiority cluster randomised trial (the Ambroisie Project).Landais, M., Nay, MA., Auchabie, J., et al.[2021]
The implementation of new guidelines for enteral nutrition in a surgical intensive care unit led to a significant reduction in the time to start enteral feeding, with a median of 1 day compared to 2 days before the guidelines were introduced (p < 0.001).
There was no increase in aspiration events or adverse effects associated with earlier enteral feeding, indicating that the guidelines improved nutritional support without compromising patient safety.
Introduction of guidelines to facilitate enteral nutrition in a surgical intensive care unit is associated with earlier enteral feeding.Zacharias, N., Blank, R., Bittner, EA., et al.[2018]
Early enteral feeding within 48 hours of starting mechanical ventilation in critically ill patients significantly reduces ICU mortality by about 20% and hospital mortality by approximately 25%, particularly benefiting the sickest patients among the 4,049 studied.
Despite the mortality benefits, early enteral feeding is associated with an increased risk of developing ventilator-associated pneumonia (VAP), highlighting the need for careful monitoring in these patients.
Effects of early enteral feeding on the outcome of critically ill mechanically ventilated medical patients.Artinian, V., Krayem, H., DiGiovine, B.[2006]

References

Continuous enteral nutrition compared with a maximal gastric vacuity strategy at the time of extubation in the intensive care unit: protocol for a non-inferiority cluster randomised trial (the Ambroisie Project). [2021]
Introduction of guidelines to facilitate enteral nutrition in a surgical intensive care unit is associated with earlier enteral feeding. [2018]
Effects of early enteral feeding on the outcome of critically ill mechanically ventilated medical patients. [2006]
Continuous versus Intermittent Enteral Tube Feeding for Critically Ill Patients: A Prospective, Randomized Controlled Trial. [2022]
Exploring fasting practices for critical care patients - A web-based survey of UK intensive care units. [2022]
Early enteral nutrition in gastrointestinal surgery: a pilot study. [2019]
Feeding by tube enterostomy. [2009]
Institutional practices of withholding enteral feeding from intubated patients. [2022]
Feeding jejunostomy in patients who are critically ill. [2009]
10.United Statespubmed.ncbi.nlm.nih.gov
Evaluation of a Nasoenteral Feeding Tube With Balloon to Facilitate Placement. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Who Places Feeding Tubes and in What Scenario? [2023]
Optimising enteral nutrition in critically ill patients by reducing fasting times. [2022]
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