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

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.

Study Overview

• Status: Completed
• Conditions: Ultrasonography; Accuracy; Critical Care, Intensive Care; Nasogastric Tube Placement
• Intervention / Treatment: Diagnostic test: ultrasonography to confirm the correct placement of a nasogastric tube in the stomach

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bellinzona, Switzerland
    • Medicina Intensiva, Ente ospedaliero cantonale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study population	Diagnostic test: ultrasonography to confirm the correct placement of a nasogastric tube in the stomach; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Ente Ospedaliero Cantonale, Bellinzona

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2018
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Estimated): November 18, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2018-00036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No