Application of Ultrasound Technique in Locating the End of the Gastric Tube in Children Aged 0-6 Years

November 28, 2024 updated by: Children's Hospital of Fudan University

To Study the Application of Bedside Ultrasound in Gastric Tube Placement and Determination of the Position of the End of the Gastric Tube in Children Aged 0 to 6 Years With Congenital Heart Disease

Application of ultrasound technique to locate the end of the gastric tube in children aged 0-6 years

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Bedside blind insertion is the most common method for gastric tube indwelling in clinical practice. The key problem is that the position of the tube cannot be accurately determined in real time.Bedside ultrasound has become a common medical technology, and resources are easy to obtain. Therefore, bedside ultrasound has the advantages of fast, accurate, real-time repeatable, and non-invasive in determining the position of the end of the indwelling gastric tube.The purpose of this study is to investigate the accuracy of bedside ultrasound in guiding gastric tube placement and judging the position of the end of the tube in children with CHD aged 0-6 years. To explore the feasibility and effectiveness of bedside ultrasound guided gastric tube placement during perioperative period in children with congenital heart disease (CHD), this study plans to procedure the prospective randomized controlled study.

Study Type

Interventional

Enrollment (Estimated)

144

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 Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Recruiting
        • CICU,Cardiovascular Center,Children Hospital of Fudan University
        • Contact:

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Children with CHD who needed gastric tube in CCU were admitted
  • children aged 0-6 years
  • Informed consent of parents

Exclusion Criteria:

  • Children with delayed sternal closure
  • The parents had cognitive impairment and mental disorders

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: According to the ultrasonic images give into stomach tube group
Other: Ultrasound was used to locate the end of the gastric tube
  1. Inform the family of the purpose and method of using bedside ultrasound to guide the placement of the gastric tube, and determine the position of the end of the tube.
  2. The ultrasound machine was connected to the power supply and placed on the right side of the patient.
  3. Select the appropriate type of gastric tube and measure the length of the indwelling gastric tube by nursing staff before inserting the tube.
  4. Nurses who had been trained in ultrasound performed ultrasound judgment on the neck and abdomen of the children. Sonographers, intensive care physicians and nursing staff jointly judged the ultrasound images.
  5. Conventional judgment method was used to determine the position of gastric tube
  6. Bedside chest radiography, with results obtained by a radiologist.
  7. Keep your child safe at all times.
Active Comparator: Conventional placing nasogastric tube group
Other: Conventional placing nasogastric tube group
  1. Choose the appropriate type of gastric tube, and measure the length of the indwelling gastric tube by the nursing staff before the tube insertion.
  2. The gastric tube was inserted by the conventional blind insertion method.
  3. The conventional judgment method was used to determine the position of the gastric tube.
  4. Bedside chest radiography, with results obtained by a radiologist.
  5. Keep your child safe at all times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of accurate gastric tube placement
Time Frame: The gastric tube is placed within ten minutes
Accuracy of gastric tube placement is defined as proportion of accurate gastric tube placement (The tip of the nasogastric tube is positioned within the body or antrum of the stomach).
The gastric tube is placed within ten minutes

Collaborators and Investigators

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

Sponsor

Children's Hospital of Fudan University

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)

December 12, 2023

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

October 18, 2024

First Submitted That Met QC Criteria

October 18, 2024

First Posted (Actual)

October 21, 2024

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

November 28, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNF202333

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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