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RecruitingNCT06077617US-FEEDUpdated Oct 11, 2023

Bedside Ultrasound Assessment of Feeding Tube Position in the Intensive Care Unit

An observational study in Critical Illness and Tube Feeding, sponsored by Hospital de Clinicas de Porto Alegre. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-11.

Sponsored by Hospital de Clinicas de Porto Alegre · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2023, 3 years ago, but the record still lists the study as recruiting.
  • Started Mar 2023; still recruiting 3 years 6 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
423
Ages
18 Years and older
Sex
All
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Study summary

This diagnostic accuracy study aims to evaluate the performance of bedside ultrasound compared to x-ray in detecting the correct position of feeding tubes among critically ill adult patients. The main questions it aims to answer are: • diagnostic accuracy of bedside ultrasound • feasibility of its wide adoption among practitioners with minimal training in busy intensive care units.

Read the detailed description

This multicenter diagnostic accuracy study consists of a non-consecutive convenience sample of adult patients admitted to the intensive care unit starting from March 2023 who require a feeding tube as defined by the medical attending team.

Right after feeding tube placement following the institutional standard operating procedure, attending physicians perform bedside ultrasound assessment to verify the correct position of the tube. They report whether or not visualizing the feeding tube in four steps: 1) in the esophagus from either the right or left side of the patient's neck; 2) in the transverse view of the patient's epigastrium; 3) in the longitudinal view of the patient's epigastrium and 4) during the injection of 20 mL of air into the tube to detect the 'fogging sign.' Finally, the abdominal radiograph (gold standard) confirms the gastric or duodenal placement of the feeding tube.

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Conditions studied

  • Critical Illness
  • Tube Feeding

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03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's planned enrollment of 423 is above the median of 130 across 867 observational studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult critically ill patients admitted in the intensive care unit undergoing a tube feeding placement as defined by the attending medical team and in accordance with the institutional standard operating procedure.

Inclusion criteria

  • Age greater than or equal to 18 years old;
  • Need for a tube feeding for receiving diet and/or medication, as indicated by the medical team;
  • Blind insertion of a tube feeding in the intensive care unit, following the standard operating procedure;
  • Presence of a trained physician for ultrasound scanning of the tube feeding immediately after installation.

Exclusion criteria

Exclusion Criteria:

  • Major abdominal postoperative wounds, peritoneostomy, or any other conditions that preclude ultrasound abdominal examination;
  • Exclusive presence of a gastric decompression probe, which does not require radiographic confirmation;
  • Tube feeding introduced under digestive endoscopy guidance;
  • Gestation;
  • Abdominal radiography confirming the tube position obtained before the ultrasound assessment.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
423 participants (estimated)
Patient registry
No

Groups and cohorts

  • Diagnostic group

    Adult ICU patients submitted to feeding tube placement according to institutional standard operating procedure

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What researchers measure

Primary outcomes

  1. Diagnostic accuracy

    Estimating sensitivity, specificity, positive predictive rate, negative predictive rate, and total accuracy of bedside ultrasound compared with abdominal radiography (gold standard). A receiver operating characteristic (ROC) curve will display the discriminatory properties of the ultrasound assessment.

    Time frame: The expected time between ultrasound assessment and abdominal radiography is under 2 hours..

07

Study locations

1 of 1 sites recruiting
  • Hospital de Clínicas de Porto Alegre
    Porto Alegre, Rio Grande Do Sul 90035-003, Brazil
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06077617
Lead sponsor
Hospital de Clinicas de Porto Alegre
Responsible party
Sponsor
First posted
Oct 11, 2023
Start date
Mar 24, 2023
Primary completion
Sep 30, 2023 (estimated)
Completion
Jul 16, 2025 (estimated)
Last update
Oct 11, 2023

Study contacts

Juliana P Antonio, PhD
Contact
juantonio@hcpa.edu.br
+555133598530
Ana Carolina P Antonio, PhD
Contact
aantonio@hcpa.edu.br
+555133598000
Ana Carolina P Antonio, PhD
principal investigator · HCPorto Alegre

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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