The Use of Ultrasound in Nasogastric Tube Placement in Children Admitted to the Pediatric ICU

April 16, 2021 updated by: Yale University

The Use of Ultrasound to Determine Correct Nasogastric Tube Placement in Children Admitted to the Pediatric ICU: a Pilot Study

The purpose of this study is to determine if ultrasound (US), when used by the clinician, can determine the presence of nasogastric tube (NGT) in the stomach of patients admitted to the pediatric intensive care unit (PICU).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Currently, the standard of care is to routinely obtain an X-ray (XR) after every nasogastric tube (NGT) placement in the pediatric intensive care unit (PICU). After obtaining informed consent and the child's assent, a short (less than 10 minutes) ultrasound (US) scan of the abdomen within 2 hours of the routine XR.

Study Type

Interventional

Phase

  • Not Applicable

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

1 second to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • PICU patient undergoing routine NGT insertion by nursing staff

Exclusion Criteria:

  • Any contraindication for US probe placement such as skin infection and abdominal wounds.
  • Hemodynamically unstable patients.
  • Patients for whom NGT placement will not be verified by XR, such as Ataxia Telangiectasia patients.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ultrasound following X-ray
An ultrasound scan of the abdomen within 2 hours of the routine X-ray will be performed by a physician blinded to the X-ray results.
Diagnostic test: Ultrasound following X-ray
A short (less than 10 minutes) ultrasound (US) scan of the abdomen within 2 hours of the routine X-ray (XR). The performer will be a physician who received a focused training on relevant US views, blinded to the XR image and report.
Other Names:
  • Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correct placement of NG tube
Time Frame: Up to 10 minutes
The operational definition will be the number of correct identification of NG tube position using ultrasound, as compared to the official X-ray read.
Up to 10 minutes

Collaborators and Investigators

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

Sponsor

Yale University

Investigators

  • Principal Investigator: Eitan Neeman, MD, Yale University - MEDPED Critical Care

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 (ANTICIPATED)

March 24, 2020

Primary Completion (ANTICIPATED)

September 30, 2020

Study Completion (ANTICIPATED)

January 31, 2021

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

September 24, 2019

First Posted (ACTUAL)

September 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 16, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2000026488

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

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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