Continuous Enteral Feeding for Tracheostomy Care

Recruiting at 5 trial locations

Overseen By Eden Nohra, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Under 18, Brain dead, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best ways to manage nutrition for patients requiring a tracheostomy, a procedure where a tube is placed in the throat to aid breathing. The researchers aim to determine whether continuing nutrition until surgery improves patients' ability to eat or increases the risk of aspiration and infections. Participants will be divided into two groups: one will continue receiving enteral nutrition until surgery, while the other will stop it 6 hours prior. The trial seeks ICU patients on breathing tubes scheduled for a tracheostomy. As an unphased trial, it offers patients the chance to contribute to research that could enhance care for future tracheostomy patients.

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 prior data suggests that this protocol is safe for tracheostomy patients?

Research has shown that continuing tube feeding until surgery, such as a tracheostomy (where a tube is placed in the windpipe to assist breathing), is generally safe. Studies have found that this method provides necessary nutrition without increasing the risk of food entering the lungs, which could cause infections.

Patients who continued tube feeding did not face a higher risk of food entering their airway or lungs compared to those who stopped feeding before surgery. This suggests that this approach is safe for patients undergoing a tracheostomy, enabling them to maintain better nutrition without added risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing continuous enteral feeding versus withholding feeds prior to tracheostomy because it could redefine how we prepare patients for this procedure. Current practice often involves withholding feeds to reduce the risk of aspiration, but this can lead to nutritional deficits. By examining the effects of continuing feeds right up until the tracheostomy, researchers hope to uncover whether this approach can maintain nutritional status without increasing complications. This trial could lead to a new standard that balances safety with better nutrition, potentially improving recovery and outcomes for patients with tracheostomies.

What evidence suggests that this trial's treatments could be effective for tracheostomy care?

This trial will compare two approaches to enteral feeding for tracheostomy care. In one arm, participants will continue feeds up until the time of tracheostomy. Research has shown that providing nutrition directly to the stomach or intestine right up until a tracheostomy can improve nutritional intake by reducing breaks in feeding. Studies have found that this method helps maintain consistent nutrition, preventing underfeeding and leading to better patient outcomes. Previous findings suggest that continuous feeding is more effective at reaching nutrition goals than stopping feeds hours before surgery. Ensuring adequate nutrition is crucial, especially in critical care, as it can affect recovery and overall health. ^{1 2 3 4 6}

Who Is on the Research Team?

Marcy Jordan, PhD

Principal Investigator

University at Buffalo

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Feeds withheld Experimental Treatment 1 Intervention

Enteral feeds are withheld at least 6 hours prior to time of tracheostomy.

Group II: Feeds continued Experimental Treatment 1 Intervention

Enteral feeds are continued up until time of tracheostomy.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Published Research Related to This Trial

The new nasoenteral feeding tube with a distal tip balloon successfully facilitated post-pyloric migration in 70% of critically ill patients by the following morning, demonstrating its efficacy in providing enteral nutrition.

The design of the tube, which includes a balloon to prevent deep placement into the lungs and a kink-resistant feature, significantly reduced the risk of misplacement and occlusion, making it safer and easier for nurses to use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Nasoenteral Feeding Tube With Balloon to Facilitate Placement. Gabriel, S., Ackermann, R., Gabriel, S., et al.[2020]

A service improvement project in a London ICU showed that implementing a fasting guideline significantly reduced interruptions to enteral nutrition delivery, particularly during airway procedures.

The guideline not only decreased fasting times but also led to a notable reduction in calorie deficits for critically ill patients, improving their overall nutrition delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimising enteral nutrition in critically ill patients by reducing fasting times. Segaran, E., Barker, I., Hartle, A.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Tube enterostomy feeding is a safe and well-tolerated method for providing long-term nutritional therapy to patients who cannot eat enough by mouth, effectively reversing protein-calorie malnutrition.

For optimal results, feeding should be delivered into the stomach or jejunum, and healthcare providers must understand the differences in commercial feeding formulations to ensure efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feeding by tube enterostomy. Torosian, MH., Rombeau, JL.[2009]

A survey of 80 anesthesia and critical care training programs revealed significant differences in the duration of withholding enteral feeding from intubated patients before extubation, with anesthesia departments recommending a median of 6 hours compared to shorter times from other specialties.

No programs withheld enteral feeding for patients undergoing MRI/CT scans or when placed in the Trendelenberg position, indicating a consensus on these specific procedures, but a need for standardized guidelines for other procedures like extubation and tracheostomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Institutional practices of withholding enteral feeding from intubated patients. Schneider, JA., Lee, YJ., Grubb, WR., et al.[2022]

Enteral feeding is crucial for the nutritional support of critically or chronically ill patients, and using a feeding jejunostomy tube can be an effective method for this.

The study recommends using a cuffed tube jejunostomy with a Tenckhoff catheter to reduce complications associated with tube feeding and improve the delivery of nutritional therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feeding jejunostomy in patients who are critically ill. McGonigal, MD., Lucas, CE., Ledgerwood, AM.[2009]

In a pilot trial involving 56 patients who underwent gastrointestinal surgery, early enteral nutrition (EN) was found to be well tolerated, with only a 19.5% incidence of side effects, primarily nausea and vomiting.

The study suggests that early EN can promote faster recovery of bowel function and potentially shorten hospital stays, indicating it may be a safe and effective option for postoperative care in patients with recent anastomoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early enteral nutrition in gastrointestinal surgery: a pilot study. Velez, JP., Lince, LF., Restrepo, JI.[2019]

A survey of 176 UK intensive care units revealed that only 20% had established fasting guidelines for critically ill patients receiving enteral nutrition, leading to inconsistent fasting practices that may contribute to underfeeding.

Units with more dietetic involvement were more likely to have guidelines and shorter fasting times for procedures, suggesting that increased dietitian presence could improve nutrition delivery in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring fasting practices for critical care patients - A web-based survey of UK intensive care units. Segaran, E., Lovejoy, TD., Proctor, C., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 99 critically ill patients on mechanical ventilation, continuous enteral feeding led to a higher rate of achieving at least 80% of target nutrition requirements within the first 7 days compared to intermittent feeding (65.0% vs. 52.4%).

The results suggest that continuous enteral feeding is a more effective strategy for meeting nutritional needs in critically ill patients, with a statistically significant relative risk of 1.24 (p = 0.008).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous versus Intermittent Enteral Tube Feeding for Critically Ill Patients: A Prospective, Randomized Controlled Trial. Lee, HY., Lee, JK., Kim, HJ., et al.[2022]

Feeding tubes can be placed by various medical specialists, including gastroenterologists, interventional radiologists, and surgeons, with similar complication rates reported across these methods.

Fluoroscopically and surgically placed feeding tubes tend to have higher technical success rates compared to those placed endoscopically, suggesting that the choice of placement method may depend on specific patient needs and institutional practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Who Places Feeding Tubes and in What Scenario? Shah, A., Busch, RA., Koepsel, EK., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of early enteral feeding on the outcome of critically ill mechanically ventilated medical patients. Artinian, V., Krayem, H., DiGiovine, B.[2006]

Citations

1. east.org east.org/content/documents/revised_proposal_chopko.pdf

Continuation of Enteral Feeds up to the Time of ... We believe that continuing feeds up to the time of tracheostomy and PEG placement will decrease feed interruptions thereby increasing quantitative nutritional ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5009025/

Effectiveness of enteral feeding protocol on clinical outcomes ... Enteral feeds and clinical outcomes before and after implementation of the protocol will be compared to see its effectiveness. There are various enteral ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05906472?term=AREA%5BBasicSearch%5D(holds)&rank=2

PUSH-IT Continuing Enteral Feeds for Tracheostomy To this end, the goal of the present study is to implement a protocol designed to decrease the interruption of enteral feeds in critical care patients ...

4. withpower.com withpower.com/trial/phase-malnutrition-1-2023-710ce

Continuous Enteral Feeding for Tracheostomy Care Continuous enteral feeding helps maintain consistent nutrition and reduces the risk of underfeeding, which can lead to worse outcomes in critically ill patients ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8839656/

Continuous versus Intermittent Enteral Tube Feeding for ... We hypothesized that continuous enteral feeding would result in higher rates of achieving target nutrition during the first 7 days compared with intermittent ...

6. east.org east.org/content/documents/east_proposal_edited_01.02.2023.pdf

Preventing Unnecessary Surgeon Holds on Ingestion for ... We hypothesize that continuing enteral tube feeds in critically ill intubated patients up to the time of tracheostomy does not increase risk of aspiration ...