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Completed

NCT Number: NCT04331873

Confirming Proper Replacement of Dislodged Gastrostomy Tubes in Pediatric Patients

The purpose of this study is to evaluate if ultrasound can be used effectively to confirm location of gastrostomy tube (G-tube) placement in place of a study in which contrast is flushed through the G-tube and placement is checked with X-ray. A G-tube is a tube inserted through the abdomen and delivers nutrition directly into the stomach.

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Key information

Age range

0 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LeBonheur Children's Hospital

Memphis, Tennessee, 38103, United States

About this study

The purpose of this study is to determine if ultrasound is a safe and reliable way to confirm the proper placement of a dislodged gastrostomy tube in a pediatric emergency department.

In the case of emergent replacement of dislodged gastrostomy tubes, the emergency department currently obtains a contrast injection of the gastrostomy tube to confirm proper replacement in patients who recently had gastrostomy surgically placed or those who require dilation/have difficult replacement as per the pediatric surgery protocol. In this study, an ultrasound (US) will be obtained by an US technician to assess if the gastrostomy tube is in the proper location. Once this study has been obtained, the patient will undergo the typical contrast injection of the gastrostomy tube to confirm placement. The sensitivity and specificity of ultrasound to the current gold standard of contrast injection will be compared.

Ultrasound (US) has the benefit of having no radiation exposure for the patient. In patients anticipated to have multiple emergency department visits a year for gastrostomy complications, using ultrasound as opposed to contrast injection may make a significant impact on accumulated radiation exposure.

The patient population will be composed of children ages 0 to 21 years that visit Le Bonheur Children's Hospital Emergency Department (Memphis, TN) for replacement of a dislodge gastrostomy tube who require contrast injection to confirm proper replacement. Once it is determined that imaging is needed to confirm replacement, the patient and legally authorized representative (LAR) will be consented for the study. The determination for contrast injection is made per protocol when gastrostomy was placed within the last 3 months or when a difficult replacement occurs (i.e. one requiring stoma dilation). A procedure checklist will be used for the provider to complete for the procedure that can be used to better evaluate the amount of attempts made to replace the tube and different methods used prior to decision to pursue contrast injection.

The LAR's will be consented for the study once they are in their private exam room in the ER. Consent, and assent when applicable, will be obtained for the study as well as discussion of risks of improper gastrostomy placement and it's risk of infection. However, this will not be deviating from the current standard of care for emergent gastrostomy replacement.

When patient goes to the radiology department, they will have an US performed by US technician who will inject Pedialyte solution through the gastrostomy and visualize fluid entering the stomach in sagittal and transverse views. These ultrasound images will not have any effect on the patient's ER course in real time and will be read by the attending radiologist the following day. Furthermore, the risk of Pedialyte injection into an improperly placed gastrostomy tube has already been discussed with pediatric surgery and radiology and is determined to be of no risk of harm to the patient as any misplaced tube would require confirmation with contrast injection at this point in time. The patient will then have contrast injection performed as per the standard of care to confirm placement and then will return to their ER exam room for further management during their visit based on the results of their contrast injection study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Dislodged gastrostomy tube requiring contrast injection to confirm proper gastrostomy replacement

Exclusion criteria

  • No ultrasound technician present in hospital
  • Non-functioning ultrasound equipment (e.g. due to hardware issues)

Treatment and study plan

Ultrasound

Diagnostic Test

An ultrasound will be obtained prior to obtaining the standard contrast injection to determine if this imaging modality is equivocal.

Other names: US

Primary outcomes

  1. Confirmation of gastrostomy tube placement

    Time frame: This procedure is brief (<5-10 minutes) and will be performed after gastrostomy tube replacement prior to the patient having the gold standard contrast injection performed before returning to their exam room. This should take no more than one hour

    Ultrasound will be obtained in addition to contrast injection to determine gastrostomy tube placement

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Collaborators

  • Le Bonheur Children's Hospital

Registry information

Official study title

Confirming Proper Replacement of Dislodged Gastrostomy Tubes in Pediatric Patients: Can we Replace Contrast Injection With Ultrasound

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 2, 2020
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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