Nasogastric Tubes for Bronchiolitis

Overseen By Leroy Crawley, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Arkansas Children's Hospital Research Institute

Disqualifiers: Bacterial pneumonia, Cranio-facial anomalies, Congenital heart disease, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 60 minutes

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to evaluate whether placing nasogastric tubes for gastric decompression improves respiratory distress for patients with bronchiolitis who are receiving oxygen via high-flow nasal cannula.

Will I have to stop taking my current medications?

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

Is it safe to use nasogastric tubes in humans?

Nasogastric tubes are generally safe for delivering nutrition and medication, but incorrect placement can lead to serious complications like pneumothorax (air in the chest cavity) or hemothorax (blood in the chest cavity). Proper training and verification of tube placement are crucial to avoid these risks. ^{1 2 3 4 5}

How does nasogastric tube placement differ from other treatments for bronchiolitis?

Nasogastric tube placement is unique for bronchiolitis as it provides nutrition directly to the stomach when oral feeding is not possible, unlike other treatments that may focus on respiratory support. It is commonly used in children during the bronchiolitis season, especially in hospitals, to ensure they receive adequate nutrition while recovering. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment Nasogastric tube placement for bronchiolitis?

While there is no direct evidence for using nasogastric tubes specifically for bronchiolitis, nasogastric tubes are commonly used for feeding in children with feeding difficulties and have been shown to be an effective method for providing nutrition. They are also used in various medical settings to ensure patients receive necessary nutrients when they cannot eat by mouth. ^{1 10 11 12 13}

Who Is on the Research Team?

David Spiro, MD, MPH

Principal Investigator

AR Children's Hospital

Are You a Good Fit for This Trial?

This trial is for babies and toddlers up to 23 months old with bronchiolitis who are receiving oxygen through a high-flow nasal cannula. It's not suitable for those with tracheostomy, short gut syndrome, congenital heart disease, G-tube dependence, cranio-facial anomalies or bacterial pneumonia.

Inclusion Criteria

My doctor diagnosed me with bronchiolitis.

I am under 2 years old.

You are using a high-flow nasal cannula at a rate of 4 liters per minute or more.

Exclusion Criteria

You have had a condition called short gut syndrome in the past.

I was born with a heart condition.

I have had or currently have a tracheostomy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive nasogastric tube placement for gastric decompression while on high-flow nasal cannula

60 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 days

What Are the Treatments Tested in This Trial?

Interventions

• Nasogastric tube placement

Trial Overview The study is testing if using nasogastric tubes to remove stomach contents can help ease breathing difficulties in young patients with bronchiolitis on high-flow oxygen therapy.

How Is the Trial Designed?

Group I: Nasogastric tube placement Experimental Treatment 1 Intervention

Nasogastric tube placement is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as NG tube for:

• Gastric decompression
• Nutritional support
• Medication administration
• Removal of gastric contents

Approved in United States as NG tube for:

• Gastric decompression
• Nutritional support
• Medication administration
• Removal of gastric contents
• Bowel obstruction
• Ileus

Approved in Canada as NG tube for:

• Gastric decompression
• Nutritional support
• Medication administration
• Removal of gastric contents

Approved in Japan as NG tube for:

• Gastric decompression
• Nutritional support
• Medication administration

Approved in China as NG tube for:

• Gastric decompression
• Nutritional support

Approved in Switzerland as NG tube for:

• Gastric decompression
• Nutritional support
• Medication administration

Who Is Running the Clinical Trial?

Arkansas Children's Hospital Research Institute

Lead Sponsor

Trials

141

Recruited

5,025,000+

Published Research Related to This Trial

In a study of over 2.7 million hospital discharges, patients with nasogastric (NG) tubes or percutaneous endoscopic gastrostomy (PEG) had a significantly higher risk of bronchial aspiration and aspiration pneumonia, with odds ratios of 9.1 and 15.2 respectively, compared to those without these feeding devices.

Patients using NG tubes or PEG experienced longer hospital stays (averaging 9.2 and 12.7 more days) and higher diagnostic complexity and costs, indicating that while enteral nutrition is effective, it can lead to serious complications that impact overall healthcare resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bronchopulmonary complications associated to enteral nutrition devices in patients admitted to internal medicine departments. Marco, J., Barba, R., Lázaro, M., et al.[2014]

In a study of 290 children with respiratory infections, the presence of indwelling nasogastric tubes (NGTs) did not significantly affect the rate of pulmonary aspiration, with rates of 29.8% in NGT patients compared to 32.3% in those without NGTs.

The results suggest that while pulmonary aspiration rates were high in children with underlying health issues, NGT feeding did not compromise the accuracy of salivagram tests used to assess aspiration risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of nasogastric tube on salivagram result in paediatric patients. Wu, H., Zhao, X., Ting Kung, B., et al.[2020]

The Home Enteral Feeding Transitions (HEFT) program successfully increased the utilization of home enteral nutrition (HEN) for infants discharged from the NICU by 10%, indicating a more standardized approach to managing feeding dysfunction in neonates.

Parents reported high satisfaction with HEN (8.6/10), and the program demonstrated safety and effectiveness, with no increase in emergency department visits or admissions related to HEN after discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creation of a Standard Model for Tube Feeding at Neonatal Intensive Care Unit Discharge. White, BR., Ermarth, A., Thomas, D., et al.[2021]

A new bedside method for placing nasoenteric feeding tubes was successfully used in 28 out of 31 patients, demonstrating a high success rate of 90.3%.

This technique, which involves gravity, corkscrewing the tube, and air injection for position verification, offers an effective and cost-efficient alternative to more invasive methods like endoscopy or fluoroscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bedside enteral feeding tube placement into duodenum and jejunum. Thurlow, PM.[2017]

Caregivers often lack knowledge about how to properly place nasogastric (NG) tubes in children for enteral nutrition, highlighting a need for better education and resources.

The article offers best practices and templates for caregiver education, drawing on effective patient education materials from Canadian and Australian programs to improve the training of caregivers in NG tube placement and care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Nasogastric Feeding Tubes for Children at Home: A Template for Caregiver Education. Lyman, B., Rempel, G., Windsor, K., et al.[2018]

A survey of 205 nurses from 166 institutions revealed that while 64% believe radiographs and 24% believe pH measurements are best practices for confirming nasogastric tube (NGT) placement, actual usage shows that only 42% use pH measurement and 23% use radiographs, indicating a gap between belief and practice.

Despite an overall increase in the adoption of evidence-based practices (EBP) for NGT placement verification since the NOVEL project, significant variability remains within institutions, particularly in Neonatal Intensive Care Units (NICUs), where non-evidence-based methods are still commonly used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of methods used to verify nasogastric feeding tube placement in hospitalized infants and children - A follow-up study. Northington, L., Kemper, C., Rempel, G., et al.[2022]

Training radiographers to interpret nasogastric tube position and using a standardized commenting proforma led to a high adherence rate of 92.9% in following the new safety pathway for tube placement in children.

The accuracy of radiographer comments was 97%, and prompt communication resulted in the safe use of 88.8% of nasogastric tubes, significantly reducing the risk of misplaced tubes and improving patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate chest radiograph interpretation by radiographers improves patient safety related to nasogastric feeding tube placement in children. Keyte, E., Roe, G., Jeanes, A., et al.[2022]

A survey of 1203 nurses revealed that 76% would use multiple methods to verify nasogastric tube placement, with pH testing being the most common initial method, indicating a cautious approach to patient safety.

Despite the majority taking precautions, there were notable gaps in knowledge regarding the management of gastric residual volume and addressing patient distress during tube feeding, highlighting the need for improved training and updated guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasogastric feeding practices: a survey using clinical scenarios. Chan, EY., Ng, IH., Tan, SL., et al.[2012]

The Dobhoff tube is designed to be more comfortable for patients than traditional nasogastric tubes, making it a popular choice for feeding and medication administration.

However, there are significant risks associated with its insertion, including the rare but serious complication of right-sided hemothorax due to inadvertent tracheobronchial placement, highlighting the need for careful placement techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemothorax Following Traumatic Dobhoff Tube Insertion. Shain, LM., McHale, L., Ahmed, T.[2021]

Nearly 800,000 nasogastric tubes are utilized annually in the NHS, highlighting their importance in medical care.

These tubes are especially common in children's nursing, particularly in neonatal units and children's wards during the winter bronchiolitis season, indicating their critical role in managing respiratory conditions in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning through leadership. Marlow, T.[2019]

Nasogastric tubes are useful for short-term feeding when oral intake isn't possible, but their insertion carries risks, including potential misplacement into the lungs.

A case is highlighted where a nasogastric tube was incorrectly positioned in both main bronchi, emphasizing the need for a chest x-ray after placement to prevent serious respiratory complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inadvertent insertion of a nasogastric tube into both main bronchi of an awake patient: a case report. Takwoingi, YM.[2021]

Capnography is a highly effective method for confirming the correct placement of nasogastric (NG) tubes, showing 100% sensitivity and 95% accuracy in a study of 60 ICU patients.

In contrast, epigastric auscultation is less reliable, with only 83.4% accuracy, suggesting that capnography should be the preferred method for ensuring safe NG tube placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The comparison of capnography and epigastric auscultation to assess the accuracy of nasogastric tube placement in intensive care unit patients. Heidarzadi, E., Jalali, R., Hemmatpoor, B., et al.[2021]

In a review of 381 radiographs, it was found that only 41% of orogastric and nasogastric feeding tubes in neonates were placed correctly, indicating a high prevalence of improper placements at 59%.

The study highlights the urgent need for improved guidelines and methods to ensure accurate placement of feeding tubes in neonates to enhance safety and effectiveness in enteral feeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Malposition of feeding tubes in neonates: is it an issue? Quandt, D., Schraner, T., Ulrich Bucher, H., et al.[2022]

Citations

1. Spain pubmed.ncbi.nlm.nih.gov

Bronchopulmonary complications associated to enteral nutrition devices in patients admitted to internal medicine departments. [2014]

2. England pubmed.ncbi.nlm.nih.gov

Effect of nasogastric tube on salivagram result in paediatric patients. [2020]

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

Creation of a Standard Model for Tube Feeding at Neonatal Intensive Care Unit Discharge. [2021]

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

Bedside enteral feeding tube placement into duodenum and jejunum. [2017]

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

Use of Nasogastric Feeding Tubes for Children at Home: A Template for Caregiver Education. [2018]

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

Evaluation of methods used to verify nasogastric feeding tube placement in hospitalized infants and children - A follow-up study. [2022]

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

Immediate chest radiograph interpretation by radiographers improves patient safety related to nasogastric feeding tube placement in children. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Nasogastric feeding practices: a survey using clinical scenarios. [2012]

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

Hemothorax Following Traumatic Dobhoff Tube Insertion. [2021]

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

Learning through leadership. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Inadvertent insertion of a nasogastric tube into both main bronchi of an awake patient: a case report. [2021]

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

The comparison of capnography and epigastric auscultation to assess the accuracy of nasogastric tube placement in intensive care unit patients. [2021]

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

Malposition of feeding tubes in neonates: is it an issue? [2022]