Accuracy of Ultrasonography in Confirming Correct Positioning of Nasogastric Tube in the Intensive Care Setting

NCT06693219 | Completed

• 1 other identifier: 2018-00036
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study was to test whether a sonographic examination instead of an X-ray allows the position of a tube in the stomach to be checked. Participants were patients admitted at an intensive care unit who required a nasogastric tube for several reasons (for example nutrition). After obtaining an informed consent from the patient or the family, the researchers checked the position of the tube with ultrasound and compared it with the gold standard, which is radiography. Data analysis allowed the concordance between the two tests to be analyzed.

Conditions

Nasogastric Tube Placement; Accuracy; Ultrasonography; Critical Care, Intensive Care

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of ultrasonography in determining correct nasogastric tube placement in the stomach

  In order to assess its diagnostic accuracy (sensitivity, specificity, negative predictive value, positive predictive value) we compared the index test (ultrasonography) against the reference standard (X-ray)

  Through study completion (enrollment of approximately 180 patients)

Study Arms (1)

Study population

EXPERIMENTAL

Diagnostic Test: ultrasonography to confirm the correct placement of a nasogastric tube in the stomach

Interventions

ultrasonography to confirm the correct placement of a nasogastric tube in the stomach DIAGNOSTIC_TEST

The sonographic examination consisted of three parts: neck scan, epigastric scan, and injection test using a mixture of 25 mL NaCl 0.9% and 25 mL room air through the nasogastric tube to detect dynamic fogging

Study population

Eligibility Criteria

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

You may qualify if:

• age ≥ 18 years
• an already inserted nasogastric tube or required nasogastric tube insertion
• no contraindication for chest or abdominal X-ray
• no contraindication for neck and upper abdominal ultrasonography

You may not qualify if:

• pregnancy
• basal skull fractures
• facial fractures
• previous or recent surgery of the neck, esophagus or stomach

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead

Study Sites (1)

Medicina Intensiva, Ente ospedaliero cantonale

Bellinzona, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 18, 2024
• Study Start: May 24, 2018
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)