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

NCT06077617 | Unknown

• 1 other identifier: 2022-0627
• Study Type: observational
• Target: 423
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Illness; Tube Feeding

Outcome Measures

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.

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

Study Arms (1)

Diagnostic group

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ana Carolina P Antonio, PhD

  HCPorto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana P Antonio, PhD

CONTACT

+555133598530; juantonio@hcpa.edu.br

Ana Carolina P Antonio, PhD

CONTACT

+555133598000; aantonio@hcpa.edu.br

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 11, 2023
• Study Start: March 24, 2023
• Primary Completion: September 30, 2023
• Study Completion: July 16, 2025
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

BR (1)