Nasotrak System for NG Tube Placement

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

90 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.

What data supports the effectiveness of the Nasotrak System treatment for NG tube placement?

The research highlights the importance of accurately placing nasogastric tubes to prevent complications, and studies have explored methods like capnography (measuring carbon dioxide levels) to ensure correct placement. This suggests that systems designed to improve placement accuracy, like the Nasotrak System, could be effective in reducing errors and improving patient outcomes. ^{1 2 3 4 5}

Is the Nasotrak System for NG Tube Placement safe for humans?

There have been reports of harm, including deaths, from misplaced nasogastric tubes, with feed entering the lungs. Safety alerts have been issued to improve practices, but the risk of misplacement remains, suggesting the need for standardized procedures to enhance safety. ^{6 7 8 9 10}

How does the Nasotrak System for NG tube placement differ from other treatments?

The Nasotrak System is unique because it uses visual guidance with a microimaging fiber integrated into the nasogastric tube, allowing for more accurate placement and reducing the risk of misplacement and mucosal damage compared to conventional methods. ^{1 11 12 13 14}

What is the purpose of this trial?

The purpose of this study is to evaluate the safety, efficacy and accuracy of the Nasotrak System in an adult patient population.

Research Team

David Tan, Beng

Principal Investigator

Nasotrak Medical Pte Ltd

Eligibility Criteria

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.

I am pregnant or breastfeeding.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Nasotrak System Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Nasotrak Medical Pte Ltd

Lead Sponsor

Trials

1

Recruited

90+

Findings from Research

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]

References

1. 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]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Nurse initiated reinsertion of nasogastric tubes in the emergency department: a randomised controlled trial. [2019]

3. Australia pubmed.ncbi.nlm.nih.gov

Implementation of the evidence review on best practice for confirming the correct placement of nasogastric tube in patients in an acute care hospital. [2011]

4. England pubmed.ncbi.nlm.nih.gov

Quality improvement programme reduces errors in oral medication preparation and administration through feeding tubes. [2020]

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

Nasogastric tubes: insertion, placement, and removal in adult patients. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Guidelines for testing the placing of nasogastric tubes. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Avoiding never events: improving nasogastric intubation practice and standards. [2022]

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

Factors associated with mechanical device-related complications in tube fed patients: A multicenter prospective cohort study. [2023]

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

Patient safety matters: reducing the risks of nasogastric tubes. [2019]

10. Brazil pubmed.ncbi.nlm.nih.gov

Nasogastric/nasoenteric tube-related adverse events: an integrative review. [2021]

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

Ultrasound-guided nasogastric feeding tube placement in critical care patients. [2022]

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

Does Bedside Sonography Effectively Identify Nasogastric Tube Placements in Pediatric Critical Care Patients? [2022]

13. Egypt pubmed.ncbi.nlm.nih.gov

Novel Visual Nasogastric Tube Insertion System: A Feasibility and Efficiency Study in a Manikin. [2020]

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

Securing the nasogastric tube in head and neck cancer patients. [2013]