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

NCT ID: NCT06077617

Last Updated: 2023-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

423 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-24

Study Completion Date

2025-07-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critical Illness Tube Feeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diagnostic group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ana Carolina P Antonio, PhD

Role: PRINCIPAL_INVESTIGATOR

HCPorto Alegre

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Juliana P Antonio, PhD

Role: CONTACT

+555133598530

Ana Carolina P Antonio, PhD

Role: CONTACT

+555133598000

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Juliana P Antonio

Role: primary

+555133598530

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-0627

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.