Clinical trial NCT04331873: Confirming Proper Replacement of Dislodged Gastrostomy Tubes in Pediatric Patients
Official title: Confirming Proper Replacement of Dislodged Gastrostomy Tubes in Pediatric Patients: Can we Replace Contrast Injection With Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrostomy Tube Site Complication
Gastrostomy Complications
Keywords: gastrostomy
dislodged
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: Le Bonheur Children's Hospital
First posted: 2020-04-02
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Confirmation of gastrostomy tube placement
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: LeBonheur Children's Hospital
state: Tennessee
Study officials:
affiliation: Le Bonheur Children's Hospital
name: Rudy A Kink, MD
role: STUDY_DIRECTOR
References:
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