Confirming Proper Replacement of Dislodged Gastrostomy Tubes in Pediatric Patients
Condition: Gastrostomy Tube Site Complication; Gastrostomy Complications
Study type: Interventional

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.
    

Intervention name(s): Ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): An ultrasound will be obtained prior to obtaining the standard contrast injection to determine if this imaging modality is equivocal.
Other intervention name(s): US
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: gastrostomy; dislodged