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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare using ultrasound imaging to look at the position of the gastrostomy tube (GT) against fluoroscopic imaging in pediatric patients who had a recent GT tube replacement. The main questions it aims to answer are: * If ultrasound is just as accurate as fluoroscopy to assess the GT position. * If ultrasound takes less time than fluoroscopy to assessing the GT position. Participants will be imaging using ultrasound to assess GT positioning before their standard of care fluoroscopic imaging.

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 data supports the idea that Ultrasound for Feeding Tube Placement is an effective treatment?

The available research shows that using ultrasound for feeding tube placement is effective. One study found that ultrasound can accurately confirm the position of feeding tubes, similar to traditional X-rays, but with added benefits like providing more detailed information. Another study highlighted that ultrasound is useful for placing feeding tubes in patients where other methods are not possible. Additionally, using ultrasound at the bedside can improve patient satisfaction by speeding up the process and reducing hospital stay time. ^{1 2 3 4 5}

What safety data exists for ultrasound in medical procedures?

The safety of diagnostic ultrasound, including its use in medical procedures, has been extensively studied. Various international expert groups and national safety committees have published guidelines and recommendations to ensure safe use. These guidelines emphasize the importance of balancing clinical benefits with potential risks, and they provide information on safe acoustic output levels. The FDA regulates acoustic output in the USA, but there is a trend towards self-regulation, requiring users to be knowledgeable about safety indices and potential bio-effects. Continuous education and awareness are crucial for safe ultrasound application. ^{6 7 8 9 10}

Is Ultrasound Imaging a promising treatment for placing feeding tubes?

Yes, Ultrasound Imaging is a promising treatment for placing feeding tubes. It helps doctors accurately place the tubes when other methods are not possible, and it provides important information that other techniques can't offer. It's also quick and can be done right at the patient's bedside. ^{2 3 4 11 12}

Research Team

William Pryor, MD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Sonography as an alternative to radiography for nasogastric feeding tube location. [2022]

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

Percutaneous sonographic gastrostomy: method, indications, and problems. [2022]

3. China pubmed.ncbi.nlm.nih.gov

[Rapid location of nasointestinal tube by bedside ultrasound for critical patients in emergency intensive care unit]. [2018]

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

Confirmation of transpyloric feeding tube placement by ultrasonography. [2022]

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

Bedside ultrasound maximizes patient satisfaction. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Diagnostic ultrasound equipment. Safety and dosimetry. [2005]

7. Germany pubmed.ncbi.nlm.nih.gov

Safety Aspects of Perinatal Ultrasound. [2021]

8. Italy 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). [2021]

9. England pubmed.ncbi.nlm.nih.gov

Ultrasonic imaging: safety considerations. [2021]

10. England pubmed.ncbi.nlm.nih.gov

International recommendations and guidelines for the safe use of diagnostic ultrasound in medicine. [2022]

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

Ultrasound guidance in percutaneous gastrostomy and gastrojejunostomy. [2019]

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

A novel approach to confirming nasogastric tube placement in the ED. [2022]