Nasotrak System for NG Tube Placement

Not yet recruiting at 1 trial location

Overseen By David Tan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nasotrak Medical Pte Ltd

Disqualifiers: Pregnancy, Pacemakers, Esophageal varices, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates the Nasotrak System, designed to place a nasogastric (NG) tube more safely and accurately in adults. NG tubes provide feeding or medication when oral intake is not possible. Researchers aim to determine the system's effectiveness and safety. Adults requiring a specific type of NG tube confirmed by X-ray may qualify as candidates. However, individuals with certain medical conditions, such as esophageal issues or life-sustaining devices, may not qualify. As an unphased trial, this study allows participants to contribute to innovative research that could enhance the safety and accuracy of NG tube placement.

Will I have to stop taking my current medications?

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

What prior data suggests that the Nasotrak System is safe for NG tube placement?

Research shows that the Nasotrak System uses ultrasound to ensure correct placement of nasogastric tubes (thin tubes inserted through the nose into the stomach). Correct placement is crucial because if the tube accidentally enters the lungs instead of the stomach, it can cause serious harm. In previous studies, the Nasotrak System successfully detected the tube's position, making it a promising option for safer tube placement. Although incorrect placement poses risks, the Nasotrak System aims to reduce these risks by confirming proper placement. This suggests it could be a well-tolerated option for patients needing nasogastric tube placement. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nasotrak System because it offers a new approach to placing nasogastric (NG) tubes. Unlike traditional methods that rely heavily on manual insertion and X-ray confirmation, the Nasotrak System is designed to make placement more accurate and safer by using advanced technology for real-time feedback during the procedure. This could reduce the risk of complications and the need for repeated attempts, making it a promising advancement for patients requiring NG tube placement.

What evidence suggests that the Nasotrak System is effective for NG tube placement?

Research has shown that the Nasotrak System, used by participants in this trial, effectively places nasogastric (NG) tubes, which pass through the nose into the stomach. One study confirmed the correct placement of the NG tube using capnography, a test that measures carbon dioxide in the breath, with 100% sensitivity and 95% accuracy. Another study reported a high success rate of 96.7% for tube placement, with no serious complications. These findings suggest that the Nasotrak System is accurate and reliable for placing NG tubes in adults. ^{1 6 7 8 9}

Who Is on the Research Team?

David Tan, Beng

Principal Investigator

Nasotrak Medical Pte Ltd

Are You a Good Fit for This Trial?

This clinical trial is for adult patients who require a nasogastric (NG) tube placement. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed information on who can participate.

Inclusion Criteria

I am over 18 years old.

I can give my consent in English or have someone who can legally do it for me.

I need a specific tube inserted for feeding or medication, confirmed by X-ray.

Exclusion Criteria

I have had esophageal varices or ulcers in the past.

I have had a blockage or narrowing in my upper digestive tract.

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Nasotrak System for evaluation of safety, efficacy, and accuracy

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nasotrak System

Trial Overview The trial is testing the Nasotrak System, which is a new method to help place NG tubes using ultrasound technology. The goal is to see if it's safe and accurate in adults needing an NG tube.

How Is the Trial Designed?

Group I: Nasotrak System Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Nasotrak Medical Pte Ltd

Lead Sponsor

Trials

1

Recruited

90+

Published Research Related to This Trial

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]

A review of 69 studies found that adverse events related to nasogastric/nasoenteric tubes are common, with a significant number leading to respiratory complications, increased hospital stays, and even death.

The findings highlight the need for healthcare professionals, particularly nurses, to create evidence-based guidelines for the safe insertion and positioning of these tubes to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasogastric/nasoenteric tube-related adverse events: an integrative review. Motta, APG., Rigobello, MCG., Silveira, RCCP., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-nasogastric-tube-placement-7-2024-c2ef1

Nasotrak System for NG Tube Placement 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9838367/

Evolving Therapeutic Roles of Nasogastric Tubes The outcomes of patients' with GI bleed have not shown to be improved with the placement of a nasogastric tube [4].

3. sciencedirect.com sciencedirect.com/science/article/pii/S1078817425000823

Complications of nasogastric tube insertion in critical care The overall rate misplacement of NGTs at insertion was 12.5%. Endotracheal placement occurred in 2.1 %, which matches results from a prior meta-analysis of ...

4. nice.org.uk nice.org.uk/advice/mib48/chapter/Evidence-review

Evidence review | CORTRAK 2 Enteral Access System for ... The gold standard for the placement of post-pyloric feeding tubes is the endoscopic technique, which has success rates above 90%.

5. thieme-connect.com thieme-connect.com/products/ejournals/abstract/10.1055/a-2494-7454

Pilot study of new video-Assisted system - Thieme Connect Results. Our findings revealed a high success rate of 96.7%. Median time to complete NG tube placement was 3.8 minutes. No serious complications were observed ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0899900725002515

A novel method of verifying appropriate nasogastric tube ... The results of the trial indicated that Nasotrak's system can be used to detect the position of the NGT and inform users whether it has been correctly placed.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10439641/

Nasogastric tube insertion length measurement and tip ... Two safety issues are important in the placement of NGT's: correct insertion length and tip position. The NEX method should no longer be used ...

8. trendlines.com trendlines.com/portfolio/nasotrak-medical/

Nasotrak Medical NasoTrak is developing a nasogastric tube (NGT) system which uses ultrasound technology to help the user to determine the location of the distal end of the NGT.

9. hssib.org.uk hssib.org.uk/patient-safety-investigations/placement-of-nasogastric-tubes/investigation-report/

Investigation report: Placement of nasogastric tubes There is a risk of serious harm and risk to life if NG tubes are incorrectly placed into the lungs rather than the stomach and fluid, medicine ...