Ultrasound for Feeding Tube Placement

Overseen By Desma Jones

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Age >18, Hemodynamically unstable

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether ultrasound imaging can verify the position of feeding tubes in children, instead of the usual X-ray method, fluoroscopy. The goal is to determine if ultrasound is equally accurate and faster. It targets children who recently had their feeding tube replaced and may have experienced accidental movement or removal. This could benefit families seeking quicker and safer methods for feeding tube checks. As an unphased trial, it offers families the chance to contribute to research that may lead to safer, faster alternatives for these checks.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that ultrasound imaging is safe for assessing gastrostomy tube position in pediatric patients?

Research has shown that using ultrasound to place feeding tubes in children is generally safe. Studies have found this method effective and free of complications. For instance, one study reported that ultrasound-guided feeding tube placement was safely completed in 34 out of 38 cases without any problems. Another study demonstrated an 87% success rate on the first attempt, with no issues reported. Overall, these findings suggest that ultrasound reliably and efficiently checks feeding tube positions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using ultrasound imaging for feeding tube placement because it could offer a safer and less invasive alternative to the standard fluoroscopic imaging. Unlike fluoroscopy, which involves exposure to radiation, ultrasound uses sound waves, eliminating the risk of radiation exposure. This makes it particularly appealing for repeated use, especially in vulnerable populations like children or critically ill patients. Additionally, ultrasound is portable and can be used at the bedside, potentially speeding up the process of tube placement and reducing the need for patients to be moved to specialized imaging rooms.

What evidence suggests that ultrasound imaging is effective for assessing gastrostomy tube position?

Research has shown that ultrasound is quite accurate for checking feeding tube placement, similar to traditional x-rays. Some studies found that ultrasound can be safe, quick, and effective, especially for children. However, limited evidence suggests that ultrasound alone might not always suffice to confirm tube placement without another method. Despite this, ultrasound generally achieves a high success rate and is fast, making it a promising option for checking feeding tube positions. In this trial, all participants will undergo ultrasound imaging before the standard fluoroscopic imaging. ^{1 2 4 5 6}

Who Is on the Research Team?

William Pryor, MD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for pediatric patients who have recently had a gastrostomy tube (GT) replaced. It's designed to see if ultrasound can be as effective and quicker than fluoroscopy in checking the position of GT tubes.

Inclusion Criteria

My feeding tube was placed surgically less than 3 months ago.

Traumatic GT dislodgement/removal

Clinician uncertainty about position of GT placement

Exclusion Criteria

I am older than 18 years.

Acutely ill patients defined as hemodynamically unstable defined as any child who has abnormal vital signs or disruption of vital functions (i.e. airway, breathing, circulation, mental function). Vital signs are based on patient age. Initial assessment of clinical patient stability will be provided by the ordering/referring provider.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Evaluation

Participants undergo ultrasound imaging to assess GT positioning before standard fluoroscopic imaging

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasound Imaging

Trial Overview The study is testing the use of ultrasound imaging to assess the positioning of gastrostomy tubes against the standard method, which uses fluoroscopic imaging. The aim is to determine accuracy and speed.

How Is the Trial Designed?

Group I: Ultrasound Imaging Experimental Treatment 1 Intervention

This study consists of one group/ All participants will receive ultrasound imaging prior to the standard of care fluoroscopic imaging.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Published Research Related to This Trial

Bedside sonography is highly effective for confirming the position of nasogastric feeding tubes, achieving a sensitivity of 97% in a study of 33 ICU patients.

Using sonography significantly reduces procedure time to a median of 24 minutes compared to 180 minutes for conventional radiography, making it a faster and more practical option for ICU physicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sonography as an alternative to radiography for nasogastric feeding tube location. Vigneau, C., Baudel, JL., Guidet, B., et al.[2022]

Ultrasound-guided placement of gastric feeding tubes was successfully performed in 34 out of 38 patients with upper gastrointestinal obstruction, demonstrating its feasibility as a method when endoscopic placement is not possible.

The procedure was safe, with no major complications reported, and it helped stabilize body weight and nutritional parameters in patients over a mean follow-up of 4 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous sonographic gastrostomy: method, indications, and problems. Bleck, JS., Reiss, B., Gebel, M., et al.[2022]

Ultrasonography proved to be more effective than radiography for accurately placing transpyloric feeding tubes, as it provided real-time functional information about tube position.

The use of ultrasound allowed for the detection of transpyloric reflux of feedings, which is critical for ensuring proper feeding tube function and patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Confirmation of transpyloric feeding tube placement by ultrasonography. Greenberg, M., Bejar, R., Asser, S.[2022]

Ultrasound is generally considered a safer imaging option for fetal and neonatal scanning compared to other diagnostic methods, especially during the perinatal period, which is less vulnerable than earlier trimesters.

The paper provides detailed procedures for obtaining clinically relevant ultrasound images while prioritizing safety, highlighting the need for careful consideration of potential biological effects on developing tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Aspects of Perinatal Ultrasound. Sande, R., Jenderka, KV., Moran, CM., et al.[2021]

Diagnostic ultrasound is widely used in various medical fields, including obstetrics, oncology, and cardiology, to monitor health and visualize conditions, but its increasing use for keepsake scans raises safety concerns.

The review emphasizes the need to evaluate the safety of diagnostic ultrasound by analyzing existing laboratory and epidemiological evidence to ensure that the benefits of its use outweigh any potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasonic imaging: safety considerations. Ter Haar, G.[2021]

Ultrasound guidance was successfully used in 27 out of 238 feeding tube placements (11%) when nasogastric tube placement was not possible due to upper gastrointestinal obstruction.

The use of ultrasound allowed for rapid and safe puncture of the stomach in 26 patients, with no complications reported, demonstrating its efficacy as an alternative method for feeding tube placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound guidance in percutaneous gastrostomy and gastrojejunostomy. Pugash, RA., Brady, AP., Isaacson, S.[2019]

A survey of 105 members of the Italian National Society for Ultrasound revealed that while most physicians understand the bio-effects of ultrasound, only 50-60% correctly defined key safety terms like thermal index and mechanical index.

The results indicate a significant gap in knowledge regarding ultrasound safety, particularly concerning the mechanical index and its potential risks, highlighting the need for improved education and awareness among ultrasound practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge of the bio-effects of ultrasound among physicians performing clinical ultrasonography: Results of a survey conducted by the Italian Society for Ultrasound in Medicine and Biology (SIUMB). Piscaglia, F., Tewelde, AG., Righini, R., et al.[2021]

A study involving 70 critical patients demonstrated that bedside ultrasound (vessels signe method) is highly effective for confirming the correct placement of nasointestinal tubes, achieving 100% sensitivity and accuracy.

In comparison to traditional methods like auscultation and aspirate testing, which had lower sensitivity and specificity, the ultrasound method significantly outperformed them, indicating it could be a safer and more reliable option for tube placement confirmation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rapid location of nasointestinal tube by bedside ultrasound for critical patients in emergency intensive care unit]. Zhang, MQ., Chen, H., Zhang, K., et al.[2018]

Ultrasound-assisted confirmation of nasogastric tube (NGT) placement using 2-dimensional imaging is a quick and effective alternative to the traditional chest X-ray method in emergency departments.

This method utilizes both soft tissue neck and epigastric imaging, providing a novel approach that enhances the safety and efficiency of verifying NGT placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel approach to confirming nasogastric tube placement in the ED. Nguyen, L., Lewiss, RE., Drew, J., et al.[2022]

The survey highlights current opinions on the safety of diagnostic ultrasound applications, indicating a need for ongoing evaluation of its safety profile.

The paper outlines specific labeling requirements for ultrasound equipment as proposed by the Netherlands' Committee on the Safety of Ultrasound, emphasizing the importance of clear communication regarding output levels and potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic ultrasound equipment. Safety and dosimetry. Thijssen, JM., van Beekum, WT., Daniëls, O., et al.[2005]

Modern ultrasound technology can deliver high levels of acoustic energy, which raises concerns about potential bioeffects; international expert groups have established safety guidelines to mitigate these risks.

In the USA, the FDA regulates ultrasound output, but there is a trend towards self-regulation, allowing higher intensity levels, especially for fetal exposure, which necessitates increased user awareness and education on safety and risk assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International recommendations and guidelines for the safe use of diagnostic ultrasound in medicine. Barnett, SB., Ter Haar, GR., Ziskin, MC., et al.[2022]

Patients who received bedside ultrasound (US) reported significantly higher satisfaction scores in overall emergency department care, diagnostic testing, and their perception of the emergency physician compared to those who did not receive US, based on a study of 70 patients over 10 months.

The use of bedside US not only expedited care and diagnosis but also enhanced the patient-physician relationship, highlighting its importance in improving patient satisfaction in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bedside ultrasound maximizes patient satisfaction. Howard, ZD., Noble, VE., Marill, KA., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6478184/

Ultrasonography for confirmation of gastric tube placement Recent studies have reported that ultrasonography provides good diagnostic accuracy estimates in the confirmation of appropriate tube placement.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022346817302105

Ultrasound-guided gastrostomy tube placement: A case ... Ultrasound-guided G-tube placement is a novel technique for gastrostomy tube placement in children and appears initially to be safe, efficient and effective.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06077617

Bedside Ultrasound Assessment of Feeding Tube Position ... This diagnostic accuracy study aims to evaluate the performance of bedside ultrasound compared to x-ray in detecting the correct position of feeding tubes among ...

4. pocusjournal.com pocusjournal.com/article/17785/

The Utilization of Point of Care Ultrasound ... They showed a first-pass success rate of 87% with a median insertion time of 15 minutes, and no complications or adverse events [14]. Although ...

5. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD012083.pub3/abstract

Ultrasonography for confirmation of gastric tube placement Based on limited evidence, ultrasound does not have sufficient accuracy as a single test to confirm gastric tube placement.

6. withpower.com withpower.com/trial/phase-gastrostomy-3-2024-5d17e

Ultrasound for Feeding Tube Placement Ultrasound-guided placement of gastric feeding tubes was successfully performed in 34 out of 38 patients with upper gastrointestinal obstruction, demonstrating ...