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Gastric Feeding TubesGUTNCT06595537

Gastric Ultrasound Feeding Tube Placement Confirmation Study

An observational study of Gastric Feeding Tubes and Ultrasound, run by Leiden University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Objective This study aims to assess the accuracy and reliability of ultrasound in determining the correct placement of gastric feeding tubes (GFTs) in intensive care patients. Study Design A diagnostic study will be conducted to evaluate the efficacy of ultrasound in determining GFT placement in all ICU patients who… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Feeding Tubes, Ultrasound
What is being tested?
Hand held ultrasound
Type of treatment
Medical device
How many people
58 participants
Where
1 siteNetherlands
Study dates
18 Dec 2023to Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population consists of tracheally intubated ICU patients in need of GFT placement or replacement, who are willing to participate in the study and provide informed consent.

Who may be able to join

  • Being tracheally intubated
  • Have a gastric feeding tube which needs replacement for any particular reason e.g the GFT is not functioning, has been displaced, and the patient has no exclusion criteria ( zie 4.3).
  • Need a gastric feeding tube
  • Given informed consent directly

Who cannot join

  • Does not need a gastric feeding tube and doesn't have one.
  • Laparotomy wound interfering with abdominal ultrasound.
  • Patient in prone position
  • No informed consent

Trial locations and contacts

1 site in 1 country.

Jorge E. Lopez Matta, M.D. contact

+316715269111 ext. 97933

J.E.Lopez_Matta@lumc.nl

David J. Van Westerloo, M.D., pHD contact

+316715269111 ext. 97957

D.J.van_Westerloo@lumc.nl

Netherlands1 site, 1 recruiting
  • Ledien University Medical Center

    Leiden, South Holland, 2315VA

    Jorge E Lopez Matta, MD, +31625214588, J.E.Lopez_Matta@lumc.nl

    David J. Van Westerloo, MD, pHD, +36715269111, D.J.van_Westerloo@lumc.nl

    Recruiting

Other trials in Netherlands

About this study

Objective

This study aims to assess the accuracy and reliability of ultrasound in determining the correct placement of gastric feeding tubes (GFTs) in intensive care patients.

Read more

Study Design

A diagnostic study will be conducted to evaluate the efficacy of ultrasound in determining GFT placement in all ICU patients who require GFT placement. Patients will undergo ultrasound by an ultrasonographer (USG) after receiving a new or replaced GFT. The USG will assess the presence or absence of a "mosaic sign" after insufflation of 20 mL of air through the GFT. The mosaic sign indicates proper GFT placement in the stomach.

Methods

All ultrasonographic measurements will be recorded and saved in a central picture archiving and communication system (PACS). The images will be labeled with the deepness of the GFT (20 cm, 50 cm, or tracheobronchial) and anonymized before being presented to an intensivist expert in USG for interpretation.

Hypothesis

A 20 mL air insufflation via a GFT at the esophageal level or via a suction catheter in the tracheobronchial system will not produce a "mosaic sign" on ultrasound. This sign will only be present if the GFT is properly positioned in the stomach.

Read the detailed description

Objective: To evaluate the effectiveness of ultrasound Doppler in determining the correct placement of gastric feeding tubes (GFTs) in intensive care patients compared to the standard of care, chest X-ray (CXR).

Study Design: A diagnostic study involving ICU patients who require GFT placement or replacement.

Background: Misplacement of GFTs is a common complication in ICU settings, with significant potential consequences for patient safety. Ultrasound Doppler has emerged as a potential alternative to CXR for confirming GFT placement due to its portability, ease of use, and real-time assessment.

Methods:

Subject Selection: Subjects will be recruited from the ICU at the Leiden University Medical Center (LUMC) who meet the inclusion criteria: tracheally intubated, require GFT placement or replacement, and provide informed consent.

Ultrasound Procedure: At the esophageal and gastric levels, ultrasound will be performed using a Philips Lumify® S4-1 broad band sector array transducer. An antrum Doppler window will be set to visualize the "mosaic sign," a characteristic Doppler signal indicative of correct GFT placement.

Image Acquisition and Coding: During ultrasound, 20 ml of air will be injected through the GFT, and images will be captured. These images will be anonymized and labeled with the depth at which the insufflation occurred (20 cm or 50 cm) or the location of the insufflation (tracheal suction catheter).

Ultrasound Interpretation: An intensivist expert in ultrasound will blind to the original localization of the GFT analyze the anonymized images. The intensivist will classify each image as having a "mosaic sign present" or "mosaic sign absent."

Correlation with CXR: The ultrasound interpretation will be compared to the gold standard of CXR to determine the sensitivity and specificity of ultrasound Doppler.

Secondary Objectives:

  • Investigate the correlation between false positive and false negative results and patient characteristics such as gender, BMI, positive end-expiratory pressure (PEEP), tidal volume, and presence of abdominal gas in CXR.
  • Assess the safety of ultrasound Doppler in terms of adverse events (AEs) and serious adverse events (SAEs).

Sample Size: A sample size of 58 patients is expected to provide sufficient power to detect statistically significant differences in sensitivity and specificity between ultrasound Doppler and CXR.

Ethical Considerations:

Ethical Approval: The study protocol has been approved by the Leiden University Medical Center Ethical Review Board (LUMC-ERB).

Informed Consent: All participants will provide informed consent prior to undergoing ultrasound Doppler and CXR.

Safety Monitoring: Adverse events will be monitored and reported as per the regulations of the LUMC and the Medical Research Involving Human Subjects Act (WMO).

Administrative Aspects:

Data Collection and Storage: Patient and clinical data, including anonymized ultrasound images and CXRs, will be collected and stored using the Castor cloud-based clinical data management system.

Monitoring: The study will be monitored by internal monitors of the Leiden University Medical Center (LUMC).

Reporting: Annual progress reports will be submitted to the accredited METC, and the final study report will be submitted upon completion of the study.

Expected Findings:

Ultrasound Doppler is expected to demonstrate high sensitivity and specificity in determining the correct placement of GFTs in ICU patients compared to CXR.

Potential correlation between false positive and false negative results with certain patient characteristics, such as gender, BMI, and presence of abdominal gas in CXR, may be identified.

The safety profile of ultrasound Doppler is expected to be favorable with minimal AEs and no SAEs.

Conclusion: This study aims to evaluate the efficacy of ultrasound Doppler in determining the correct placement of GFTs in ICU patients. The findings of this study will contribute to the development of non-invasive methods for confirming GFT placement, potentially improving patient safety and reducing the need for CXRs.

Being tested
Hand held ultrasound
Keywords
gastric ultrasound, Gastric feeding tube, Point of care ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hand held ultrasoundDevice

    Also called Lumify handheld ultrasound

    Determination of gastric feeding tube position with the use of Lumify handheld ultrasound

Study groups in NCT06595537
Study groupRoleWhat they receive
Ultrasound control of air insufflation in tracheobronchial suction catheter, oesofagus and stomachPatients will receive a gastric feeding tube. At mid-esophagus level and at gastric level, placement of the gastric feeding tube will be controlled through doppler-ultrasound after air-insufflation. Ultrasound control after air insufflation will also take place after placing a suction catheter through the endotracheal tube in the trachea. Finally the gastric feeding tube placement will be confirmed with chest X-ray.
Receives: Device: Hand held ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Test effectiveness of ultrasound in determining gastric feeding tube position in stomach.

    To assess the effectiveness of the test we will calculate its sensitivity and specificity. Sensitivity in this case being the proportion of images categorized as having a "mosaic sign present" by the blinded intensivist and indeed representing a gastric GFT localisation (objectivized by CXR). Specificty being the proportion of images categorized as "mosaic sign absent" and representing a non-gastric GFT localisation ( Air insuflation at 20cm GFT insertion and in tracheal canula (TB)). Sensitvity and Specificity will be expressed as a percentage as well as false positive and false negative rates. With this information we will be able to calculate the Likelihood Ratio (LR) for a positive result and for a negative result.

    The analysis will be done using the statistical program SPSS.

    Measured: ultrasound control of gastric feeding tube, confirming with X-ray

Secondary outcomes (1)
  1. Correlating results with basline patient demographic, ventilator settings and post procedure chest x-ray findings.

    Correlation of false positive and false negative results with demographic parameters, ventilator settings and chest x-ray findings.

    Measured: baseline and post procedure ( gastric feeding tube) chest x-ray

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start18 Dec 2023
  3. Primary completionAug 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06595537
Sponsor's protocol ID
NL77930.058.21
Acronym
GUT
Status last verified
Sep 2024
First submitted
12 Jan 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlies results in a publication

Publications

  • Gomes GF, Pisani JC, Macedo ED, Campos AC. The nasogastric feeding tube as a risk factor for aspiration and aspiration pneumonia. Curr Opin Clin Nutr Metab Care. 2003 May;6(3):327-33. doi: 10.1097/01.mco.0000068970.34812.8b.

    PubMed 12690267
  • Lo JO, Wu V, Reh D, Nadig S, Wax MK. Diagnosis and management of a misplaced nasogastric tube into the pulmonary pleura. Arch Otolaryngol Head Neck Surg. 2008 May;134(5):547-50. doi: 10.1001/archotol.134.5.547. No abstract available.

    PubMed 18490579
  • Wendell GD, Lenchner GS, Promisloff RA. Pneumothorax complicating small-bore feeding tube placement. Arch Intern Med. 1991 Mar;151(3):599-602.

    PubMed 1848058
  • Wong KW, Chan HH, Wong CP, Chan MY, Chau JCW, Wong TW. Using color flow detection of air insufflation to improve accuracy in verifying nasogastric tube position. Am J Emerg Med. 2017 Feb;35(2):333-336. doi: 10.1016/j.ajem.2016.12.046. Epub 2016 Dec 21.

    PubMed 28038826
  • Vigneau C, Baudel JL, Guidet B, Offenstadt G, Maury E. Sonography as an alternative to radiography for nasogastric feeding tube location. Intensive Care Med. 2005 Nov;31(11):1570-2. doi: 10.1007/s00134-005-2791-1. Epub 2005 Sep 20.

    PubMed 16172849
  • Chenaitia H, Brun PM, Querellou E, Leyral J, Bessereau J, Aime C, Bouaziz R, Georges A, Louis F; WINFOCUS (World Interactive Network Focused On Critical Ultrasound) Group France. Ultrasound to confirm gastric tube placement in prehospital management. Resuscitation. 2012 Apr;83(4):447-51. doi: 10.1016/j.resuscitation.2011.11.035. Epub 2011 Dec 29.

    PubMed 22209831
  • Kim HM, So BH, Jeong WJ, Choi SM, Park KN. The effectiveness of ultrasonography in verifying the placement of a nasogastric tube in patients with low consciousness at an emergency center. Scand J Trauma Resusc Emerg Med. 2012 Jun 12;20:38. doi: 10.1186/1757-7241-20-38.

    PubMed 22691418

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Feeding Tubes and Ultrasound, run by Leiden University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jorge E. Lopez Matta, M.D. (+316715269111 ext. 97933, J.E.Lopez_Matta@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Test effectiveness of ultrasound in determining gastric feeding tube position in stomach. (time frame: ultrasound control of gastric feeding tube, confirming with X-ray). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06595537, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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