Ultrasound to Check the Position of the Nasogastric Tube (SONUS)

December 20, 2024 updated by: Ángel Becerra, Dr. Negrin University Hospital

Ultrasound to Check the Adequate Position of the Nasogastric Tube to Improve Patient Management and Safety

The main objective of this study is to evaluate whether the use of ultrasound as a method of checking the normal positioning of the NGT is reliable, without requiring other diagnostic tests. Clinical trial that will include patients who had the NGT placed intraoperatively. 114 patients (57 with NGT and 57 without NGT) will be examined by ultrasound in the immediate postoperative period to diagnose the normal positioning of the NGT or its absence.

Can ultrasound quickly and effectively diagnose the normal positioning of the NGT? Can chest X-ray be avoided by introducing ultrasound in the verification of the normal positioning of the NGT in the immediate postoperative period?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The nasogastric tube (NGT) is an essential element of our daily clinical practice, commonly used for the administration of enteral nutrition and medication or for gastric decompression and diagnostic procedures. Despite its common use, it is still an invasive procedure with potential complications. Ultrasound is a noninvasive, inexpensive, widely available and rapid method that can speed up the proper verification of these devices. The main objective of this study is to evaluate whether the use of ultrasound as a method of checking the normal positioning of the NGT is reliable, without requiring other diagnostic tests. Clinical trial that will include patients who had the NGT placed intraoperatively. 114 patients (57 with NGT and 57 without NGT) will be examined by ultrasound in the immediate postoperative period to diagnose the normal positioning of the NGT or its absence. Patients who have had the NGT placed will have had their NGT placed correctly by chest X-ray. The upper part of the patient will be covered for the examiner, who will only have access to the patient's abdomen and will not know which patients have NGT or not.

Study Type

Interventional

Enrollment (Estimated)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Las Palmas de Gran Canaria, Spain, 35010
        • Not yet recruiting
        • Hospital Universitario de Gran Canaria Doctor Negrín
    • Las Palmas
      • Palmas DE GRAN Canaria, LAS, Las Palmas, Spain, 35002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients classified as ASA I-IV according to the American Society of Anesthesiologists
  • Patients over 18 years old.
  • Informed consent signed by the patient or their family representatives

Exclusion Criteria:

  • Patients classified as ASA V.
  • Patients under 18 years old.
  • Refusal to participate in the study.
  • Contraindication for nasogastric tube placement: ingestion of caustics, nasal or skull fractures, and cervical surgery.
  • Patients with anatomical abnormalities at the cervical or pharyngoesophageal level.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with nasogastric tube placed during the intraoperative period.
Ultrasound will be performed during the postoperative period to assess the normoposition of nasogastric tube.
Diagnostic test: Postoperative ultrasound
Ultrasound will be performed to both groups in the postoperative period to assess the normoposition or the absence of nasogastric tube.
Active Comparator: Patients without nasogastric tube placed during the intraoperative period.
Ultrasound will be performed during the postoperative period to assess the absence of nasogastric tube.
Diagnostic test: Postoperative ultrasound
Ultrasound will be performed to both groups in the postoperative period to assess the normoposition or the absence of nasogastric tube.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of confirmation of normoposition of the nasogastric tube
Time Frame: First postoperative hour.
Researchers will perform postoperative abdominal ultrasound to verify proper placement of the nasogastric tube in patients who have one or its absence in those who have not had one.
First postoperative hour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Negrin University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2024

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 20, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-300-1

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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