Bedside Ultrasound Assessment of Feeding Tube Position in the Intensive Care Unit (US-FEED)

Bedside Ultrasound Assessment of Feeding Tube Position in the Intensive Care Unit: the US-FEED Study

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Tube Feeding

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.

• Study Type: Observational
• Enrollment (Estimated): 423

Contacts and Locations

• Study Contact: Name: Juliana P Antonio, PhD; Phone Number: +555133598530; Email: juantonio@hcpa.edu.br
• Study Contact Backup: Name: Ana Carolina P Antonio, PhD; Phone Number: +555133598000; Email: aantonio@hcpa.edu.br

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
      • Recruiting
      • Hospital de Clínicas de Porto Alegre
      • Contact: Juliana P Antonio; Phone Number: +555133598530; Email: juantonio@hcpa.edu.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Diagnostic group; Adult ICU patients submitted to feeding tube placement according to institutional standard operating procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The expected time between ultrasound assessment and abdominal radiography is under 2 hours..

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Ana Carolina P Antonio, PhD, HCPorto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2023
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): July 16, 2025

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 2022-0627

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No