Continuous Enteral Feeding for Tracheostomy Care

Recruiting at 4 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

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. ^{1 2 3 4 5}

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. ^{1 5 6 7 8}

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. ^{5 9 10 11 12}

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

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

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

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+

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.

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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). [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Introduction of guidelines to facilitate enteral nutrition in a surgical intensive care unit is associated with earlier enteral feeding. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of early enteral feeding on the outcome of critically ill mechanically ventilated medical patients. [2006]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Continuous versus Intermittent Enteral Tube Feeding for Critically Ill Patients: A Prospective, Randomized Controlled Trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Exploring fasting practices for critical care patients - A web-based survey of UK intensive care units. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Early enteral nutrition in gastrointestinal surgery: a pilot study. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Feeding by tube enterostomy. [2009]

8. United States pubmed.ncbi.nlm.nih.gov

Institutional practices of withholding enteral feeding from intubated patients. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Feeding jejunostomy in patients who are critically ill. [2009]

10. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Nasoenteral Feeding Tube With Balloon to Facilitate Placement. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Who Places Feeding Tubes and in What Scenario? [2023]

12. England pubmed.ncbi.nlm.nih.gov

Optimising enteral nutrition in critically ill patients by reducing fasting times. [2022]